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Events Calendar

June 2024

Date Event Location
Jun 6

Webinar: Is Your RWD Regulatory Ready? Considerations When Preparing RWD for a Regulatory Submission

Watch this webinar to learn how the TransCelerate Audit Readiness Initiative has developed a set of considerations to support audit and inspection readiness for programs incorporating real-world evidence (RWE) and focusing on processes used to document data reliability. During the webinar, panelists shared key elements of TransCelerate’s considerations and summary results of a survey to providers of data services that explored…

Virtual Group 33
Jun 6

Pharmacovigilance & Drug Safety Congress

The 3rd Pharmacovigilance and Drug Safety Conference takes place on June 6-7 in Lisbon. This conference will explore crucial topics such as pharmacovigilance, drug safety, and advancements in the pharmaceutical industry. Valentina Mancini (Shionogi) will present “PV Agreements Process Optimization” on June 6.

Jun 11

Pharmageddon USA

Pharmageddon USA is a 2-day innovation experience designed to reframe thinking from what pharma is to what it could be. They’ve thrown out drawn-out vendor presentations and predictable press readings and replaced them with Ted-talk style case studies and provocative panels. Join TransCelerate BioPharma CEO Janice Chang and Cristian Massacesi (AstraZeneca) for the panel “Patient Disruption.”…

Jun 16

DIA Global 2024

The DIA 2024 Global Annual Meeting invites industry, regulators, governments, academics, innovators, and patients to network, problem-solve, and discuss global and local challenges facing the life sciences community. Hosted in San Diego, DIA 2024 will amplify different perspectives while highlighting expertise across the globe to reimagine current processes that better enhance health and well-being. Join TransCelerate at…

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July 2024

Date Event Location
Jul 11

Webinar: Vulcan UDP (Utilizing the Digital Protocol): Collaborating to Accelerate ICH M11 and End User Value 

Join us to learn about Vulcan’s Utilizing the Digital Protocol (UDP), an umbrella project that brings together multiple initiatives to develop a digital representation of a study protocol. During this webinar, our panelists will: Panelists: Ideal Attendees: TransCelerate webinars may be recorded in whole or in part. 

Virtual Group 33

August 2024

EVENTS COMING SOON!

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September 2024

EVENTS COMING SOON!

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October 2024

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Oct 29

SCOPE Summit Europe

SCOPE Europe emphasizes the significance of clinical operations to bridge the gap between research and regulatory milestones, encouraging attendees to view their work as a crucial business endeavor. Join TransCelerate at the following sessions:

November 2024

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December 2024

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January 2025

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February 2025

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March 2025

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April 2025

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May 2025

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Jun 16

DIA Global 2024

The DIA 2024 Global Annual Meeting invites industry, regulators, governments, academics, innovators, and patients to network, problem-solve, and discuss global and local challenges facing the life sciences community. Hosted in San Diego, DIA 2024 will amplify different perspectives while highlighting expertise across the globe to reimagine current processes that better enhance health and well-being. Join TransCelerate at…

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Jun 11

Pharmageddon USA

Pharmageddon USA is a 2-day innovation experience designed to reframe thinking from what pharma is to what it could be. They’ve thrown out drawn-out vendor presentations and predictable press readings and replaced them with Ted-talk style case studies and provocative panels. Join TransCelerate BioPharma CEO Janice Chang and Cristian Massacesi (AstraZeneca) for the panel “Patient Disruption.”…

Jun 6

Pharmacovigilance & Drug Safety Congress

The 3rd Pharmacovigilance and Drug Safety Conference takes place on June 6-7 in Lisbon. This conference will explore crucial topics such as pharmacovigilance, drug safety, and advancements in the pharmaceutical industry. Valentina Mancini (Shionogi) will present “PV Agreements Process Optimization” on June 6.

Jun 6

Webinar: Is Your RWD Regulatory Ready? Considerations When Preparing RWD for a Regulatory Submission

Watch this webinar to learn how the TransCelerate Audit Readiness Initiative has developed a set of considerations to support audit and inspection readiness for programs incorporating real-world evidence (RWE) and focusing on processes used to document data reliability. During the webinar, panelists shared key elements of TransCelerate’s considerations and summary results of a survey to providers of data services that explored…

Virtual Group 33
May 16

Webinar: Pharmacovigilance Agreement Solutions You Didn’t Realize You Needed

Watch this webinar for an overview of TransCelerate’s Pharmacovigilance Agreements Optimization (PVAO) Initiative, which includes a suite of solutions designed to help organizations enhance their PVA process. These solutions can help organizations improve their processes and potentially achieve more efficient negotiations with business partners globally. ​ The webinar includes: ​ Slides can be viewed here. Watch the webinar here. Panelists: Ideal Attendees:

Virtual Group 33
Apr 24

CDISC Europe Interchange

The 2024 CDISC Europe Interchange is an event consisting of workshops, training courses, and a two-day Main Conference. CDISC Interchanges are held annually on three continents with hundreds of attendees gathering to share their expertise, best practices, and lessons learned in developing and implementing CDISC standards to bring clarity to data. Learn about the digital…

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Apr 17

Society of Clinical Data Management EMEA24

The core learning focus of the event will be cross-collaboration and its ability to drive innovation in Clinical Data Science, featuring world-class guest speakers and presentations on topics ranging from AI and cognitive tech to new ways of working. Join Swapna Pothula (GSK) for the TransCelerate session “A Paradigm Shift in Personalizing the Clinical Trial Experience…

Apr 16

Data Driven, Hybrid & Full Decentralized Clinical Trials

This conference explores the latest strategies for hybrid and full decentralized trials and technology innovation and data management for clinical trials. Join TransCelerate for the following session:

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Mar 28

Webinar: Enabling Individual Participant Data Return (iPDR): An Overview of TransCelerate’s Individual Participant Data Return Package

Join us for an overview of TransCelerate’s Individual Participant Data Return (iPDR) Package, a comprehensive set of materials that provide general considerations to enable data return to clinical study participants.  The webinar will include:  Slides can be viewed here. Watch the webinar here. Panelists: Ideal Attendees: ​

Virtual Group 33
Mar 20

Patients as Partners

Patients as Partners® in Clinical Research offers an unparalleled opportunity to hear from pharma R&D, FDA, and patient advocacy on how patient involvement gets done to drive greater efficiencies in clinical research. Check out the following sessions featuring TransCelerate speakers: 21 March, 3:15 p.m. EST: “Patient Data Access: Proactive Solutions for Standardizing and Personalizing Data…

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Mar 12

DIA Europe 2024

DIA Europe 2024 will focus on sustainability, innovation and collaboration – three key pillars for shaping the future of healthcare. From the environmental impact of pharmaceuticals and of the drug development lifecycle to sustainable partnerships and sustainable healthcare systems, DIA Europe 2024 will be the prime opportunity to discuss how collaboration and innovation can support sustainability in healthcare and each stakeholder’s role…

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Mar 11

Evolution Summit

This invite-only conference explores the key aspects and issues related to drug development. Some of the key issues for Spring 2024 include:  Intelligent Drug Development: Exploring the utilization of AI to accelerate drug development and assessing the scalability of its implementation Pushing the Envelope on Health Equity: Meaningfully advancing DEI in clinical trials through a…

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Feb 29

CRDSA: The Patient Data Revolution: From Promise to Realization

In this three-hour virtual summit, leading experts share the latest developments in patient-level data sharing and data reuse. Patient data from prior clinical trials and real-world data sources has the power to transform drug development. This summit offers a practical look at the solutions being developed to facilitate and promote responsible secondary data use. Tune…

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Feb 28

Webinar: Rapid RWD Analyses to Support Safety Signal Assessments

Join us for a presentation and panel Q&A to dive deep into the work of the Rapid Signal Assessment Using Real World Data Initiative. The webinar will give an overview of the background and methodology, an analysis of the two recently released solutions, and an outline of upcoming plans for the initiative. This webinar focuses on two…

Virtual Group 33
Feb 25

PHUSE US Connect

PHUSE US Connect offers a collaborative space where attendees have direct opportunities to hear from impactful speakers, explore new perspectives from industry experts, and get involved with the PHUSE Community. Join TransCelerate for the following sessions: “USDM Standards Uncovered: Engaging Demonstrations and Active Workshop Practices,” a collaborative workshop on 25 February from 2:30 – 4:00…

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Feb 19

DIA Japan Clinical Data Management Workshop

DIA Japan is hosting their 27th annual DIA Clinical Data Management Workshop conference, the oldest event held at DIA Japan, on February 19-20, 2024, at the Tower Hall Funabashi in Tokyo, Japan. The conference will host workshops on various topics such as Digital Data Flow, DCT, Patient Centricity / Patient and Public Involvement, AI/RPA, Data…

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Feb 11

Summit for Clinical Ops Executives (SCOPE)

Clinical trials and clinical research are essential for advancing medical knowledge, improving patient care, and developing new treatments and therapies for the patients who need them. Execution of this vital work requires collaboration, innovation, and strategic decision-making. Now in its 15th year of fostering these joint efforts to advance our medical knowledge inclusive of all…

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Dec 13

Webinar: Modernizing Clinical Trials Using Digitized Protocol Information–An Exploration of New Tools for Digital Transformation

Join us for a presentation and panel Q&A to explore the newly released resources developed by TransCelerate’s Digital Data Flow (DDF) Initiative. DDF, in collaboration with CDISC and other industry stakeholders, has built the foundational capabilities and is helping enable a digital transformation that unlocks efficiencies in the design and conduct of clinical studies while modernizing pharma to healthcare interoperability. ​ This…

Virtual Group 33
Dec 5

DIA Global Clinical Trial Disclosure and Data Transparency Conference

This virtual conference will showcase the latest developments in clinical trial disclosure and data transparency. By attending, you will gain essential and timely information on global clinical trial disclosure, data sharing for secondary research, and the EU Clinical Trial Information System (CTIS), all from the convenience of your computer or mobile device. For those in…

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Dec 4

International Society of Pharmacovigilance Intelligent Automation in Pharmacovigilance Seminar

The 7th Jubilee seminar will examine the upcoming revolution in pharmacovigilance (PV) enabled by the latest technologies. What works, what does not, what regulators allow, and how does GxP validate the advanced language models for PV? Join TransCelerate member Andrew Bate (Vice President, Head of Safety & Analytics, GSK) on 4 December for the session…

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Nov 29

Clinical Trials Europe

Clinical Trials Europe is a conference that helps attendees streamline and simplify clinical trials. Conference tracks include optimizing clinical research and clinical operations; novel technology solutions to improve outcomes and clinical efficiencies; and how to develop and maintain outsourcing partnerships and strategic alliances. Joanna Culver, Patient Engagement Lead Patient Focused Development, R&D Global Medical (GSK)…

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Nov 17

Webinar-Diversity by Design: Proactive Approaches to Facilitate Industry-Wide Diversification of Clinical Trial Participants

Join us for a presentation about the tools and information developed by TransCelerate’s Diversity of Participants in Clinical Trials Initiative to support organizations working to improve the representation of diverse patient populations in clinical trials. The webinar focuses on: An overview of the importance of improving the representation of diverse patient populations in clinical trials. Key considerations…

Virtual Group 33
Nov 12

American College of Toxicology Annual Meeting

ACT is a global community of professional scientists representing the pharmaceutical and biotech industries, regulatory agencies, contract research organizations, academia, and consulting firms. The mission of the College is to educate, lead, and serve scientists by promoting an exchange of information and perspectives on safety assessment and new developments related to applied toxicology. BioCelerate, the…

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Nov 5

DIA Japan

The 2023 DIA Japan Annual Meeting invites industry, regulatory government, academics, and patients to network, problem-solve, and discuss challenges facing the life sciences community. On November 7, join TransCelerate BioPharma for a DIAmond session, “Modernizing Research Globally: A Multi-Stakeholder Discussion Focused on Accelerating Innovation & Improving Patient Experiences.” The recent past seen unprecedented events from…

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Nov 5

PHUSE EU Connect 2023

PHUSE EU Connect 2023 covers the newest trends in clinical data science, alongside demos of valuable tools and tips on how to implement them. TransCelerate BioPharma’s Digital Data Flow Initiative and CDISC are hosting a hands-on workshop, entitled Digital Data Flow: From Vision to Reality, on 7 November from 11-12:30. Topics to be addressed in…

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Nov 2

Webinar-Offering Choice to Patients: An Overview of the Personalized Clinical Trials Framework

Feedback from clinical trial participants indicates they want options for their clinical trial experience. Join TransCelerate BioPharma for an overview of our Personalized Clinical Trials Framework, which was developed in partnership with patients, sites, and clinical research organizations. The Personalized Clinical Trials Framework is a set of practical considerations to support the R&D ecosystem (i.e.,…

Virtual Group 33
Oct 18

CDISC US Interchange

The 2023 CDISC US Interchange is an event consisting of workshops, training courses, and a two-day Main Conference. CDISC Interchanges are held annually on three continents with hundreds of attendees gathering to share their expertise, best practices, and lessons learned in developing and implementing CDISC standards to bring clarity to data. On 19 October 2023,…

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Oct 18

World Drug Safety Congress Americas

The World Drug Safety Congress Americas is the world’s largest commercial gathering of pharmacovigilance professionals. It brings together 1000+ top leaders and stakeholders in biopharma to discuss the key challenges they are facing in pharmacovigilance and device safety. The agenda covers 10 tracks and includes topic areas such as AI & Machine Learning, Global PV,…

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Oct 17

SCOPE Summit Europe

The 6th Annual SCOPE Europe: Summit for Clinical Ops Executives is a two-day executive conference serving clinical innovation leaders, clin ops execs, digital leaders, functional heads, category managers, and those responsible for the planning and management of clinical trials in Europe and the Rest of the World. This event brings together leaders from large, mid-sized,…

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Oct 8

Society of Clinical Data Management Annual Conference

The SCDM Annual Conference shares the latest insights and thought-provoking ideas with the ultimate goal to drive progress across the world and support the evolution from Clinical Data Management toward Clinical Data Science. At #SCDM23 we will explore how to engage and work together towards end-to-end streamlined collaboration to continue driving data integrity, patient safety,…

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Oct 6

SCRS Global Site Solutions Summit

For the last 18 years, the Global Site Solutions Summit has been committed to being “the site’s meeting.” The Summit provides a unique hub where sites, sponsors, CRO executives, and regulators come together to discuss best practices and ideas while developing strategic partnerships through ideation sessions, workshops, and focus groups. On 8 October 2023 at…

Hollywood, FL Group 33
Oct 4

World Drug Safety Congress Europe

The World Drug Safety Congress Europe will bring together 1500+ key thought leaders to explore key challenges in pharmacovigilance. From exploring the use of big data and AI in pharmacovigilance, and examining benefit-risk management strategies and patient-centric approaches, drug safety is at the forefront of innovative technologies that will have an impact on the lives…

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Oct 3

RAPS Convergence

RAPS Convergence is the largest and most recognized annual gathering of global regulatory affairs professionals. Convergence brings together representatives of industry, regulatory bodies, research, academia, and clinical organizations that are directly involved in managing the regulatory process and aligning science, regulation, and business strategy. TransCelerate’s plenary panel “Progressing Patient-Centered Health through Collaboration: A TransCelerate Multi-Stakeholder…

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Sep 20

DPharm: Disruptive Innovations

DPharm presents the opportunity to hear senior clinical operations executives and innovative thought leaders unveil the latest innovations to modernize clinical trials. Join TransCelerate for the plenary panel “A Multi-Stakeholder Paradigm Shift: Bringing Research to Patients” with Janice Chang, CEO, TransCelerate; Ken Getz, Executive Director, Tufts Center for the Study of Drug Development; Bari Kowal,…

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Sep 18

PHUSE CSS

The PHUSE/FDA Computational Science Symposium is an interactive workshop event providing attendees the opportunity to work with industry, regulatory agencies, and academia. The event will unite attendees from industry, regulatory and academia to support health, product development and regulatory review. It will facilitate collaboration to share experiences, solve problems and explore new concepts to drive…

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Sep 16

CRC Japan

The Clinical Research Coordinators Conference is the biggest CRC assembly in Japan. TransCelerate’s Modernizing Clinical Trial Conduct Initiative for their session, “Towards the Future of Clinical Trials: Beyond Decentralized Clinical Trials–Modernizing Clinical Trial Conduct.” TransCelerate panelists are Yumiko Miyazaki, Manager, Clinical Innovations & Business Integration (Eli Lilly), and Kazumi Yabe, Senior Manager, Regional Clinical Operations…

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Sep 14

Global Pharmacovigilance Summit

The Global Pharmacovigilance Summit is designed for professionals from pharma industry to keep up to date with new trends, requirements and regulations when it comes to Drug Safety and Risk Management in 2023. Christine Taeter, Head of Immunology Safety Unit (UCB) will present the session, “Pharmacovigilance Guidances & Regulations Governing the Use of Medicines in…

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Sep 11

Innovations in Clinical Trials Congress

Innovations in Clinical Trials Congress convenes over 150 industry leaders, innovative speakers, and participants to share ideas and best practices, co-create solutions, and empower teams and individuals to drive forward innovation in clinical trials. Tracks include benchmarking innovation in clinical trials, implementing decentralized clinical trials, and conducting sustainable patient-centric clinical trials. Join TransCelerate’s CEO Janice…

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Sep 8

Webinar: Understanding Case Reporting Transmission Networks in Drug Safety: The Impact of Replication

Join TransCelerate BioPharma for a presentation and panel discussion on our Individual Case Study Report (ICSR) Replication Paper. The article is the first quantification of the phenomenon of ICSR replication across Health Authority and marketing authorization holder safety databases. It presents a first-of-its-kind illustration of the diverging case information that can exist across data repositories. The webinar includes:​ A presentation of the analysis that quantifies the amount of ICSR replication…

Virtual Group 33
Aug 23

International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE)

The International Conference on Pharmacoepidemiology & Therapeutic Risk Management brings together more than 1,500 leaders representing industry, service providers, government/regulatory agencies, academia, consultants and students from many countries – all dedicated to advancing the health of the public. This year’s theme is “The Global Home for the Science of Real-World Evidence.” Join TransCelerate’s Real World…

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Jul 18

Australia & New Zealand Site Solutions Summit

The Australia-New Zealand Site Solutions Summit is the best place for clinical research sites, sponsors, CROs, and solution providers to come together to learn, communicate and collaborate about the latest knowledge, trends, and best practices shared by experts in Australia, New Zealand, East Asia, South Asia, and Southeast Asia regions. Through education, solution-focused dialogue, and…

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Jun 25

DIA Global 2023

The DIA 2023 Global Annual Meeting invites industry, regulatory government, academics, and patients to network, problem-solve, and discuss global and local challenges facing the life sciences community. Hosted in Boston, DIA 2023 will amplify different perspectives while highlighting expertise across the globe to reimagine current processes that better enhance health and well-being. Join TransCelerate at the following…

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Jun 22

The Use of Virtual Controls in Preclinical Research: Promise and Predicament

Join BioCelerate for its second meeting of the BioCelerate Preclinical Collaboration Forum, which brings together cross-industry stakeholders to advance conversation and innovation in preclinical research. During this forum industry leaders will address the following topics: How virtual controls may play a role in a reduce, reuse, recycle strategy (3R) Considerations to ensure the scientific validity…

Virtual Group 33
Jun 20

PHUSE Data Transparency Summer Event

PHUSE has continued to strengthen its place as the world’s largest home for data transparency events, by sharing vital knowledge of the field and creating a space where questions can be asked and challenges addressed. PHUSE Data Transparency Events take place twice a year, once in the Summer and once in Winter. The events look…

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May 10

Webinar: Attitude of Gratitude for Patients & Care Partners

Join us for an overview of TransCelerate’s Gratitude Toolkit on how sponsors can acknowledge and show appreciation to our clinical trial participants and care partners. Gratitude can help provide recognition of the challenges a patient/care partner may be facing and help support them in continuing with the clinical trial. Slides from the webinar can be…

Virtual Group 33
Apr 26

CDISC Europe Interchange 2023

Join TransCelerate’s Digital Data Flow Initiative on 26 April 2023  at CDISC Europe Interchange 2023. CDISC’s Dave Iberson-Hurtz will an update on TransCelerate’s Study Definitions Repository Reference Implementation in the session “CDISCs Activities on DDF, Benefits for the Community and Looking Ahead.” The SDR Reference Implementation is based on a Unified Study Definitions Model (USDM) developed by…

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Apr 26

Society of Clinical Data Management EMEA

SCDM’s 2023 EMEA Conference is a place for the world’s clinical data management industry to reflect on the future, creating a platform for transformational learning that can change the world of clinical data science. Join TransCelerate at the following session: “Clinical Trials 2031 & Beyond” with Christine Walsh, Principal DM Process & Innovation Specialist, Novo…

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Apr 19

European Quality Assurance Conference

The German Quality Management Association (GQMA) is Germany’s largest, and Europe’s second-largest association dedicated to quality management in the chemical and pharmaceutical industries. 2023’s European QA Conference’s slogan is “Quality — towards the next generation.” Marion Pillwein (BMS), from TransCelerate’s Interpretation of Clinical Guidances & Regulations Initiative, will present a session on “The Renovation of…

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Apr 18

Decentralized Clinical Trials

The Decentralized Clinical Trials Conference covers four tracks relating to decentralized clinical trials: Explore the Real Value of Decentralized and Hybrid Clinical Trials; Patient Centricity, Diversity and Inclusion; Partnership, Consortiums and Site Perspectives; and Regulatory Updates and Technology Digitalisation. On 20 April 2023 at 10:00 a.m. EST/EDT, William Illis, Global Head, Collaboration & Technology Strategy,…

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Mar 22

DIA Europe

DIA Europe 2023 is designed to drive insights into action by connecting key policy discussions to real-world knowledge. Gathering innovative thought leaders from the entire life science landscape, DIA always has the aspiration to be ahead of current developments, reflected by 4 new content tracks in 2023: Artificial Intelligence and Data Science EU Health Policy and…

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Mar 19

Society of Toxicology Annual Toxicology Expo

This event brings together 5,000+ toxicologists and those working in areas related to toxicology to share the latest science and technology in the field, as well as to make new connections, gather with friends, and engage in mentoring and professional development. BioCelerate’s SEND Implementation for Cross-Study Analysis will present a poster at this event.

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Mar 2

Webinar–What You Need to Know about ICH E8 (R1): Using TransCelerate’s Tools to Help Interpret and Implement ICH E8 (R1)

This webinar discusses TransCelerate’s tools and resources for ICH E8 (R1) and its implementation. These solutions target key new concepts in ICH E8 such as Critical to Quality Factors, Stakeholder Engagement, Critical Thinking, and Open Dialogue. The webinar focuses on: What’s new in ICH E8 (R1) Focus of our work and how our focus topics…

Virtual Group 33
Feb 27

A Privacy Methodology to Improve Cross-Industry Data Sharing: An Informational Session for the Public Review Period

Secondary reuse of clinical trial data can help reduce patient burden and generate key scientific insights that further the development of medications to help patients. However, differences in privacy methodologies can make it difficult to compare data from different sources. TransCelerate has combined the emergent thinking and best practices from its Member Companies into recommendations…

Virtual Group 33
Feb 6

SCOPE Summit 2023

The SCOPE Summit focuses on advances and innovative solutions in all aspects of clinical trial innovation, planning, management, and operations. TransCelerate’s initiatives represented include Patient Technology, Patient Experience, Real World Data, Interpretation of Clinical Guidances & Regulations, and Modernizing Clinical Trial Conduct. TransCelerate presentations at the 2023 SCOPE Summit: Panel Discussion: Digital Technologies to Enable…

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Feb 6

DIA Global Pharmacovigilance and Risk Management Strategies Conference

DIA’s Global Pharmacovigilance and Risk Management Strategies Conference is a neutral event developed by regulators and industry experts discussing the updates, opportunities, and challenges alongside fresh problem-solving strategies that matter most to safety professionals. Amalia Alexe (Novartis) will present on behalf of TransCelerate’s Interpretation of Pharmacovigilance Guidances and Regulations for a session on “Safety in…

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Nov 13

ACT 2022

BioCelerate will be presenting at this year’s ACT 2022 on the SEND Implementation for Cross Study Analysis Initiative with speaker Mark Carfagna (Lilly).

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Nov 7

Clinical Trials Europe

TransCelerate is excited to have multiple Initiatives being featured at this year’s Clinical Trials Europe in person in Amsterdam. Our sessions include: Modernizing Clinical Trial Conduct: Fit-for-Purpose Trials of the Future with speaker, Maurits Kok (UCB). Developing a Quality Management Checklist to support Audits of Real-World Data (RWD) Used in Regulatory Submissions with speaker, Claudia…

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Nov 1

Digital Data Flow (DDF): Connectathon Results and Outcomes

TransCelerate’s Digital Data Flow (DDF) initiative aims to transform clinical studies by enabling end-to-end digital exchange of study definition information.  The DDF Initiative recently hosted a three-week Connectathon event to experiment and demonstrate how stakeholder applications integrate and deploy the CDISC Unified Study Definitions Model (USDM) and the connectivity and interoperability of these applications to the…

Virtual Group 33
Oct 26

2022 CDISC US Interchange

Join Regulatory Transformation Lead Vijay Reddi (Roche) and Principal Programmer Mikkael Traun (Novo Nordisk) for a session on “Applying TransCelerate’s Digital Data Flow Study Definition Repository Reference Implementation Minimal Viable Product” at this year’s CDISC US Interchange. This event provides an opportunity to share progress, implementation experiences, and strategic ideas on worldwide data interchange standards…

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Oct 13

PHUSE EMEA Autumn Single Day Event

TransCelerate’s Digital Data Flow Initiative will present a poster, “TransCelerate Digital Data Flow-An Initiative to Transform How Studies are Designed & Delivered,” at this event that covers biopharma’s experience with exploring and using open-source software. Historically, open-source software has been of limited interest in the pharmaceutical industry as GxP requirements impose many limitations on statistical…

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Oct 9

DIA Japan

TransCelerate is excited to have two sessions at this year’s DIA Japan. Our session include, Innovative and Dynamic Statistical Analytics for Regulatory Submissions with speaker, Eri Sekine (Novartis). Our other session is, Breaking the Document Paradigm and Digitalizing Clinical Study Start Up with speaker, Mika Ogasawara (Pfizer).

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Oct 7

SCRS Global Summit

The Summit provides a unique hub where sites, sponsors, CRO executives, and regulators come together to discuss best practices and ideas while developing strategic partnerships through ideation sessions, workshops, and focus groups. TransCelerate will be hosting a TransCelerate Experience for our Patient Experience, Patient Technology, and Diversity of Participants in Clinical Trials Initiatives. We are…

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Sep 27

Let’s Make a PV Agreement: Three Solutions You Can Use to Enhance Your PVA Process

This webinar took place on September 27, 2022. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. TransCelerate has launched a suite of solutions designed to help organizations enhance their PV agreement process. These solutions can help organizations improve their processes and achieve more efficient negotiations with their business partners.  Webinar…

Virtual Group 33
Sep 19

PHUSE/FDA CSS 2022

PHUSE is excited to welcome attendees in-person to the 11th PHUSE/FDA Computational Science Symposium, 19-21 September 2022 taking place at the Civic Centre, Silver Spring, MD. TransCelerate will be represented by our Modernization of Statistical Analytics Initiative with speaker, Steve Hamburg (GSK). Our BioCelerate SEND Implementation for Cross Study Analysis will also be featured with…

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Sep 12

Clinical Research as a Care Option

TransCelerate is excited to have two sessions at this year’s Clinical Research as a Care Option (CRAACO). Our sessions include, Patient Equity and Partnership: From After-Action to Co-Creation with speaker, Melissa Dupont (Sanofi) and Beyond COVID-19: Modernizing Clinical Trial Conduct with speaker Susan Wong (Roche)

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Sep 12

Connect-a-thon: Digital Data Flow: Organizing and Automating The Study Protocol

Join our Digital Data Flow Initiative for the TransCelerate Connect-a-thon: Organizing and Automating The Study Protocol from September 12-30, 2022. This virtual event will focus on practical ways that companies have and can use the SDR RI and the USDM. Attend this virtual event to learn about:  Increase stakeholder knowledge and awareness of the DDF…

Virtual Group 33
Jun 20

DIA Annual

This year, DIA 2022 is excited to return to in-person programming that will bring enhanced opportunities to learn, connect, and collaborate with our key tenets remaining unchanged That patients are our story That we seek to understand That collaboration is the skill we hone That this collaboration must cross organizations, decades, languages, and boundaries to…

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May 23

ARCS Australia

The 2022 ARCS Annual Conference is on 23-25 May held at the ICC Sydney! The conference brings together industry professionals, consumers, patients, practitioners, researchers and academia to unite, educate, inform and network. We’re excited to present on our Modernization of Clinical Trial Conduct Initiative with speaker Amy Sillett (AZ) at this year’s ARCS Australia Conference.

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May 20

SCRS Diversity Summit

The Diversity Site Solutions Summit will feature critical content for clinical research sites as regulatory and sponsor directives require more mandatory inclusion of diverse populations in trials. Join clinical research executives to develop industry connections through engaging networking opportunities and solution-focused workshops. TransCelerate is excited to present our TransCelerate Experience at the first annual SCRS…

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May 17

Pharma Clinical 2022

Join 1000+ clinical leaders at Reuters Events: Pharma Clinical 2022 (May 17-19, Virtual) and come together to design the first blueprints for a patient-led clinical trial design and set shared missions, education programmes, and digital advances around patients to create trial designs that work in the real world. We are excited to have 3 sessions at this year’s…

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May 11

Webinar: Digital Data Flow: Modernizing Clinical Trials, Updates on Progress and Cross Industry Collaboration (Part 2)

This webinar took place on May 11, 2022. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. TransCelerate’s Digital Data Flow (DDF) initiative aims to transform clinical studies by enabling end-to-end digital exchange of study definition information. Join us for the second part of a two-part TransCelerate DDF…

Virtual Group 33
May 1

PHUSE US Connect

This event has been re-designed from top to bottom and will feature several concurrent events from partner organisations, statistical programming head meetings, the PHUSE/FDA Innovation Challenge and much more. Also making their debut are nine new Connect Streams such as Emerging Trends and Vaccine Development. Join our Modernization of Statistical Analytics as we focus on our…

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Apr 20

Vulcan 101: Bringing FHIR to Clinical Research

Have you heard about HL7? Or Fast Healthcare Interoperability Resources (FHIR)? Or Vulcan? If you need to understand the basics of FHIR, how FHIR can be used to move data from healthcare systems into clinical research, how FHIR connects with other standards, or what Vulcan is about, register for the event. Vulcan 101 offers a…

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Apr 20

SCOPE EU

This event brings together leaders from large, mid-sized, and small pharma, specialty pharma, biotech, vendor companies, and academic research centers who come together to share best practices and discuss the new era of decentralized, analytics-driven and patient-centric trials. The event features four conference tracks, shared plenary keynotes, interactive small breakout discussion groups, panels and networking…

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Mar 29

DIA EU 2022

DIA Europe 2022 will be held from 29-31 March in-person* in Brussels, Belgium, and virtually (attendees only), with new session formats and enhanced opportunities to learn, connect, and collaborate with all stakeholders across the entire spectrum of the life science landscape. TransCelerate will be presenting three sessions at this year’s DIA Europe: Case Studies for AI-Based Intelligent…

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Mar 1

Webinar: Digital Data Flow: Modernizing Clinical Trials, Updates on Progress and Cross Industry Collaboration (Part 1)

This webinar took place on March 1, 2022. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. Attend this webinar to learn about: Collaboration and participation in modernizing clinical data flow with insights from our panel stakeholders on the vision of DDF and value to our ecosystem of…

Virtual Group 33
Feb 7

SCOPE Summit 2022

This conference will cover four days of in-depth discussions in 22 different conferences, 3 plenary keynote sessions, the 6th annual Participant Engagement Awards, special cross-department panels, a first-time golf tournament, and the ever-popular interactive breakout discussions, the programming focuses on advances and innovative solutions in all aspects of clinical trial innovation, planning, management and operations.…

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Dec 1

DIA Clinical Trial Regulation Conference

This conference will focus on the differences between the present and new requirements for managing clinical trials in the face of forthcoming changes, including the new EU clinical trials Regulation but also conducting novel complex innovative design trials. Regulators and other decision-makers, together with various experts in the field, will debate how the new legislation…

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Nov 16

Webinar: Digital Data Flow: Modernize Clinical Trials By Enabling a Digital Workflow

This webinar took place on November 16, 2021. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. This initiative is focused on enabling vendor-agnostic, digital exchange of study definition data by collaborating with technology providers and standards bodies to create a sustainable open-source solution.   Attend this webinar…

Virtual Group 33
Nov 8

ISOP 2021

Join us for a session focused on our IGR-PV: PoRTL Initiative titled, “Presentation of Safety Risks Throughout the Product Lifecycle,” with speaker Samuel Ramsden (BI).

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Nov 5

RQA (Research Quality Association) Conference

Join us for a session discussing RWD/E and considerations for establishing QMS framework and to understand the challenges of applying GCP requirements to this context with speaker Lynette Aldrich (Eli Lilly).

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Nov 2

Pharma & Patient USA 2021

Join us for a session discussing our Patient Experience Initiative – “Leverage critical insights from patients and care partners in trial protocols to create more inclusive, patient-friendly studies” with speakers Sam Reyes (Amgen) and Pete Schaeffer (GSK).

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Nov 2

Clinical Trials EU

Join us for four sessions focused on our PE/PT and IGR-Clinical Initiatives. There will also be two plenary panels for TransCelerate. Sessions include: “Leveraging TransCelerate’s patient-centric tools in today’s modern world to improve the overall patient experience” with speaker Joachim Lovin (Novo Nordisk) “Developing a data privacy framework for the reuse of clinical data for…

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Oct 28

DIA Digital Technology in Clinical Trials

Join us for a session titled, “Approaches for Developing Novel Digital Endpoint for Medical Product Development.” Speaker Michelle Crouthamel (AbbVie) will be presenting a short course under DIA’s Regulatory track for digital endpoints in medical product development.

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Oct 25

DIA Real World Evidence Conference

Join us for a session titled, “Cross Industry Consortia Addressing RWE: Impact and Future Directions” with  speaker/presenter Cathy Critchlow (Amgen) on October 25 from 3:45 – 5:00 PM. This session will cover: What is TransCelerate (introduce to the DIA audience) Describe RWD Program overall (and put into context with other relevant initiatives within TransCelerate) Describe…

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Oct 24

DIA Japan 2021

We will be presenting four sessions at DIA Japan for October 2021. Sessions include: TransCelerate’s Intelligent Automation Opportunities in Pharmacovigilance Initiative Patient Engagement – Recent Practices and Future Enhancement in Japan Risk-based Quality Management in the E8 (R1) Era Clinical Trial Operation Model in the Near Future

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Oct 20

CDISC 2021 US Interchange

The CDISC US Interchange Conference covers the planning, design, implementation, and submission of clinical data research projects. Sessions discuss new, efficient standards models and technologies now being implemented to create more efficient, compliant, and financially sustainable research platforms. TransCelerate’s Digital Data Flow Initiative is presenting during Session 6-Track A: Cross Collaboration/Special Projects. The session will…

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Oct 5

KoNECT International Conference

Join us for a session titled, “Beyond COVID19: Modernizing Clinical Trial Conduct” with speaker Dagmar Görtz (J&J)

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Oct 5

CDISC Webinar – Digital Data Flow: Project Information and Call for Volunteers

CDISC, in collaboration with TransCelerate’s Digital Data Flow Project, is developing a reference architecture, which will serve as a standard model for the development of a Study Definitions Repository. The Repository is a novel central component aimed at facilitating the exchange of structured study definitions across clinical systems using technical and data standards. Deliverables will include…

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Sep 28

FDA Public Workshop: “COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics”

Join federal leadership and key stakeholders on September 28 for the virtual FDA public workshop “COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics.” The event will disseminate findings from the Federal COVID-19 Response or Countermeasures Acceleration Groups (formerly known as Operation Warp Speed) to bring relevant therapeutics to use in the next public health emergency. Presenters will distill learnings…

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Sep 28

Webinar: TransCelerate Framework and Methodologies for Utilizing Modernized Analytical Software Tools

This webinar took place on September 28, 2021. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. The Webinar will cover topics, such as, the challenges of Statistical Analytics environments, the practical implementation of the Modernized Statistical Analytics (MSA) Framework utilizing the Accuracy, Reproducibility and Traceability Principles and…

Virtual Group 33
Sep 23

ASA Biopharmaceutical Section Regulatory-Industry Statistical Workshop

Join us for a session titled, “Use of Historical Trial Data to Expedite Drug Development” with speaker Matthew Gribbin (Amgen).

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Sep 21

Webinar: Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach and Considerations

This webinar took place on September 21, 2021. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. Our presenters will follow Digital Medicine Society’s (DiMe) V3 framework and Clinical Trials Transformation Initiative’s (CTTI) framework in a hypothetical case to validate a sleep endpoint. We will identify key considerations…

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Sep 13

PHUSE Computational Science Symposium (CSS)

Join BioCelerate’s SEND initiative team as they collaborate with FDA and PHUSE for PHUSE Computational Science Symposium (CSS) this year.

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Sep 7

DIA Pharmacovigilance Strategies Workshop

Join us for a session titled, “Negotiating your way through the maze of vigilance agreements: would a map help?” with  speaker/presenter Weronika Trun (Bayer).

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Sep 7

ACT 2021 Conference

BioCelerate Nonclinical Common Templates Initiative is presenting an ePoster highlighting the results of the phase 1 pilot and the SEND Harmonization for Cross Study Analysis Initiative along with their collaboration partners FDA and PHUSE will be hosting a workshop as well as presenting three ePosters. Monday, November 15 – noon-3:30 PM EDT Session – Collaboratively…

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Jul 26

National Academies of Sciences, Engineering, and Medicine – National Cancer Policy Forum workshop

Join Dietmar Berger (Sanofi) for a session titled, Cancer Care and Cancer Research in the Context of the COVID-19 Pandemic: Lessons Learned. The workshop will feature invited presentations and discussion on topics such as: The impact of COVID-19 pandemic across the cancer control continuum. Clinical practice changes, such as increased use of telehealth that were…

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Jul 13

SCRS Asia-Pac​

Join moderator of panel, Brian Egan and panelists Zoe Armstrong (MSD) and Amy Sillett (AZ) for a session titled, Industry Collaboration to Improve the Future of Clinical Research. 

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Jun 27

DIA Global Annual Meeting​

Join TransCelerate for a multitude of sessions at DIA Global 2021, including: Intelligent Automation Opportunities in Pharmacovigilance: “From Opportunity to Strategy: Introducing Intelligent Automation Technologies within Pharmacovigilance for the ICSR Process” Modernization of Statistical Analytics: “The Journey to a Modernization of Analytics” Digital Data Flow: “Breaking the Document Paradigm to Digitize Study Start Up: TransCelerate’s…

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Jun 14

PHUSE Connect US 2021

PHUSE Connect will contain elements including inspirational keynote speakers, over 100 presentations, Hands-on Workshops and even social events and will be formed of a mix of live and on-demand sessions. Join TransCelerate for a session titled “Is it ART? An Application of TransCelerate’s MoA Framework for Assessing Accuracy, Reproducibility, and Traceability in Novel Software Implementations.”…

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Jun 11

CDISC Japan Interchange

Join us for a session titled, “Utilizing CDISC SEND Data to Generate Historical Control Incidence from a Large Database of Toxicology Studies” with speaker William Houser (BMS).

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Jun 9

PhRMA Workshop

Rodrigo Garcia (EMD Serono) will be presenting on behalf of TransCelerate for our Diversity of Participants in Clinical Trials Initiative. This session titled ““Efforts Aimed at Advancing Clinical Trial Diversity” will be held on June 9 from 2:25-3 pm

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Jun 7

ARCS Annual Meeting​

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May 25

Pharma USA 2021 (Formerly known as eyeforpharma Philadelphia​)

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May 24

Pharma SUG

Pharma SUG is a Software Users Group of life science and health research professionals focused on the application of technological solutions in data analytics and regulatory support. Join TransCelerate for a session titled “A TransCelerate Initiative-how can you modernize your statistical environment?”

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May 20

DIA China 2021

Join us for our session “TransCelerate’s Intelligent Automation Opportunities in Pharmacovigilance.”

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Apr 20

SCRS European Site Solutions Summit 2021

The European Site Solutions Summit focuses on clinical research site performance and the growth and contributions that sites make in the clinical research enterprise. The conference provides highly sought-after custom regional content and networking opportunities and offers cutting-edge ideas to help you successfully and proactively address increasingly complex challenges within the clinical research industry. TransCelerate…

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Apr 7

Pharma: Clinical 2021

Clinical is under the microscope. As the world focuses its lens on pharma, the opportunity and pressure are there to found a new era of agile, patient-centric clinical trials. Long-standing barriers to innovation are falling, digital transformation is accelerating, and new cultures in collaboration and patient-centricity are rapidly growing. Reuters Events Clinical 2021 is the…

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Apr 7

Patients As Partners US

Join our PT/PE workstream for our session, “Leveraging TransCelerate’s patient-centric tools in today’s modern world to improve the overall patient experience.”

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Mar 15

DIA Europe​

DIA Europe is an event for all life science professionals working in drug development, from discovery to marketed use. The program includes topics designed to advance healthcare priorities and outcomes through innovation. TransCelerate’s Intelligent Automation Opportunities in Pharmacovigilance (IAO) will conduct a session on “Strategies to Implement Routine Intelligent Automation Technologies within Pharmacovigilance for the…

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Mar 12

Society of Toxicology Annual Meeting​

BioCelerate’s Toxicology Data Sharing Initiative and its SEND Implementation for Cross-Study Analysis Initiative will present its respective ePosters at the annual meeting.

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Mar 2

SCOPE US​

The Summit for Clinical Ops Executives (SCOPE) presents new ideas to drive innovation in clinical trials and digital health. Join TransCelerate at this virtual conference for the following sessions: Modernizing Clinical Trial Conduct “Pandemic-Proof Trials of 2030: Applying Lessons Learned from COVID-19” Digital Data Flow “Lessons from TransCelerate’s Digital Data Flow Virtual Hackathon: Interoperability, Digitized…

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Feb 8

DIA Regulatory Submissions, Information, and Document Management Forum

At DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum,  industry and regulatory stakeholders working across the scope of regulatory information will share their expertise on how to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related systems. The Forum presents four tracks: Regulatory Informatics Business, Regulatory…

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Jan 25

Patients as Partners EU

Patients as Partners EU demonstrates how patient engagement and involvement gets done. It’s co-produced with industry, patient advocacy and public sector voices that provide the “know-how” to turn ideas into action. And as COVID-19 creates a new normal in clinical research, it’s more critical than ever to involve patients in every aspect of R&D, including…

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Dec 10

4th ISoP Seminar – Intelligent Automation in Pharmacovigilance

Since 2017, the International Society of Pharmacovigilance has held thought-provoking seminars on Intelligent Automation in Pharmacovigilance. Offering a unique, highly focused, scientific and interactive two-day event, 30 speakers across the pharma and technology services industry were invited to speak on this engaging topic. In recognizing the need for aligned language in describing and validating various…

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Nov 10

SCOPE Europe + Clinical Trial Innovation Summit US

Bridging Europe and US to Drive Global Clinical Innovation NOW a Combined Virtual Event! 10-11 November 2020 SCOPE Europe Building on the success of its long-running US-based counterpart, Summit for Clinical Trials Operations Executives Europe (SCOPE Europe) is a two-day event serving clinical innovation leaders, clin ops execs, functional heads, category managers, and those responsible…

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Nov 8

DIA Japan 2020

In recent years, while the fourth industrial revolution progresses, various new initiatives on innovation, which lead to novel values or substantial changes in healthcare product research & development, have begun by creation and usage of brand new ideas and technologies such as artificial intelligence, big data and utilization of medical and genome information. There are…

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Nov 8

PHUSE Connect EU

Liverpool, UK will be the host city for the PHUSE EU Connect 2020, which will take place 8th–11th November at the ACC Liverpool. Building on the previous EU Connects, this event promises to be exciting and informative with a range of concurrent streams, keynote presentations, social events and ample networking opportunities.

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Nov 2

Clinical Trials Europe 2020

ACCELERATE YOUR CLINICAL DEVELOPMENT THROUGH PARTNERSHIPS, OUTSOURCING, OPERATIONS & TECHNOLOGY Be Part Of Europe’s Largest Event Dedicated To Streamlining Clinical Trials And Improving Patient Outcomes, Without The Need To Travel Bringing The Experts And Their Insights To You That’s right! Wherever you are around the globe, you will be able to enjoy this year’s Clinical Trials…

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Oct 29

Webinar: Helping companies create a quality foundation for today’s clinical trial ecosystem using key disciplines (QMS, RBM, QTL and Protocol Deviations)

This webinar took place on October 29, 2020. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. Join us for a panel discussion as experts explore how TransCelerate’s Quality Management System, Risk-Based Monitoring, Quality Tolerance Limits, and Protocol Deviations (e.g. Quality Quartet) initiatives can help…

Virtual Group 33
Oct 27

DIA China

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Oct 26

AI Applications in Biopharma Summit

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Oct 17

PHUSE’s Innovations and Strategies in Biometrics and their Impact on Pharma

Innovation propels companies forward. It’s an unlimited source of new growth and can give businesses a distinct competitive advantage. The pharmaceutical industry is fundamentally a data-driven business. All along the value chain from research to market, we wrap our molecules around with data to prove their mode of action, their safety, and efficacy, and eventually…

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Oct 13

Demystifying Quality Tolerance Limits Webinar

This webinar took place on October 13, 2020. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. ICH E6 R2 requires Quality Tolerance Limits (QTLs) as part of Clinical Quality Management. This webinar reviewed guidance and considerations for QTL implementation in Clinical Development. Additionally, it…

Virtual Group 33
Oct 12

ARCS Annual Meeting 2020

For over 35 years, ARCS Australia has been bringing together a vibrant and diverse community of professionals working in academia, government, biotech and pharmaceutical companies, hospitals and healthcare settings and other organisations to showcase and support the development and regulation of therapeutic goods. TransCelerate will be presenting on a session entitled “Clinical trials landscape 2021…

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Oct 9

SCRS Global Site Solutions Summit

For the last 14 years, the Global Site Solutions Summit has been committed to being “the site’s meeting.” The Summit provides a unique hub where sites, sponsors, CRO executives and regulators come together and share best practices, build their businesses, and develop new partnerships through debates, ideation sessions, workshops and focus groups. SCRS is confident…

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Oct 8

Demystifying Quality Tolerance Limits Webinar

This webinar took place on October 8, 2020. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. ICH E6 R2 requires Quality Tolerance Limits (QTLs) as part of Clinical Quality Management. This webinar will review guidance and considerations for QTL implementation in Clinical Development. Additionally,…

Virtual Group 33
Oct 8

DIA Master Protocols Workshop

The urgency to speed access to innovative therapies and vaccines has never been so evident as during the COVID-19 pandemic. With literally hundreds of potential medicines candidates under investigation, the ability to work efficiently and productively relies on open collaboration within frameworks that can answer multiple clinical questions in one overall trial structure. Master Protocols…

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Sep 29

PHUSE’s Practical Applications of Data Science to Speed Clinical Trials

At the end of 2019 there were almost 320,000 clinical trials worldwide. Since the outbreak, almost 500 clinical trials have been launched to find a treatment for COVID-19. There are more clinical trials then ever, and the number keeps expanding. Better technology enables faster access and data analysis. This PHUSE Single Day Event will highlight…

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Sep 23

World Drug Safety Congress Europe

The World Drug Safety Congress Europe is empowering patients, physicians, pharma, biotech and consumers to make the best drug safety decisions. Explore the use of big data and AI in pharmacovigilance, examine benefit-risk management strategies and patient-centric approaches; discuss how you can tackle the challenges of social media and drug safety legislation globally. TransCelerate BioPharma…

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Sep 22

DPharm: Disruptive Innovations US 2020

DPharm is the annual event for clinical operation professionals to get the best access to innovative ideas, especially disruptive ones, to advance drug development with a view to reducing the burden to patients and investigators. Attendees leave DPharm with a host of ideas to solve current challenges in clinical trials and better prepared for the…

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Sep 21

PhUSE 2020 Computational Science Symposium

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Sep 15

World Pharma Week

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Sep 1

World Drug Safety Congress Americas

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Aug 18

DIA Digital Technology in Clinical Trials

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Aug 11

Clinical Study Report Considerations for Studies that Have Been Interrupted by COVID-19

This webinar took place on August 11, 2020. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. TransCelerate’s Clinical Content and Reuse team has a new asset available for download, Clinical Study Report (CSR) Considerations for Studies Disrupted by the COVID-19 Pandemic. This document was created…

Virtual Group 33
Jul 29

DIA China 2020

12th DIA China Annual Meeting 2020 is the largest, event in the life sciences industry designed to foster the international exchange of actionable insights to improve health globally through the advancement of lifesaving medicines and technologies in the APAC region. The DIA China Annual Meeting 2020 will bring together 3000+ pharmaceutical R&D professionals from different…

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Jul 7

Digitizing Clinical Study Design: A Webinar with Digital Data Flow (DDF) Distinguished Hackathon Submissions

This webinar took place on July 7, 2020. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. The DDF workstream conducted a virtual Hackathon to evaluate feasibility for the Study Design component of the DDF Vision. The DDF Hackathon attracted 175 participants to provide innovative…

Virtual Group 33
Jun 30

DIA Europe 2020

DIA Europe 2020 is the largest and most forward-looking neutral healthcare conference in Europe. This annual healthcare meeting reflects DIA’s strategic initiatives across several Thought Leadership streams, including Clinical Development & Operations, Regulatory Science & Operations, Value and Access, Medical Affairs and many others.

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Jun 14

DIA 2020 Global Annual Meeting

For more than 50 years, DIA has provided the world’s largest global, neutral stage for life science professionals to come together and address healthcare challenges. Driven by purpose and focused on the future of health, the stakeholders who gather at our Global Annual Meeting advance science and technology for public health impact – today, and…

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May 28

Exploring How TransCelerate Solutions Can Enable Clinical Trial Continuity

Join us for a panel discussion as experts explore how existing TransCelerate solutions can support Clinical Trial Continuity during times of disruption. The panel will feature experts from TransCelerate initiative teams with specific knowledge around the below areas: Tools to support centralized trial monitoring: TransCelerate’s Risk Based Monitoring methodology and tools can be leveraged to transition from conventional,…

Virtual Group 33
May 27

Exploring How TransCelerate Solutions Can Enable Clinical Trial Continuity

This webinar took place on May 27, 2020. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. Join us for a panel discussion as experts explore how existing TransCelerate solutions can support Clinical Trial Continuity during times of disruption. The panel will feature experts from…

Virtual Group 33
Apr 30

Improving Efficiencies in Nonclinical Research: Developing & Implementing Common Toxicology Protocol and Report Templates

The Roundtable will provide an opportunity for all stakeholders to further the discussion around facilitating efficiencies in toxicology-study management through the development of nonclinical common templates which should create process and time efficiencies for all stakeholders.  Roundtable participants will have the opportunity to discuss, ask questions and provide meaningful input into the BioCelerate consortium’s published…

Virtual Group 33
Apr 22

Patient Technology Tools for Industry: Designing Clinical Trials with Patient and Vendor Input

This webinar took place on April 22, 2020. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. Successful implementation and use of patient-facing digital technologies (PT) in clinical trials requires collaborative effort and input from key stakeholders including sponsors, clinical research sites, patients and technology…

Virtual Group 33
Apr 15

eyeforpharma Philadelphia 2020

North America’s largest commercial pharma conference eyeforpharma Philadelphia is the meeting place where new initiatives find their wings and where pioneering initiatives develop into game-changing strategies. The ambition to redefine the very nature of biopharma, the proximity of like-minded people, and the abundance of industry leading case-studies are the main reasons so many executives come back…

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Mar 31

eyeforpharma Barcelona 2020

The world’s largest commercial pharma conference 2000+ pharma-decision makers (from across Commercial, Sales, Marketing/Digital, IT, Medical, Patient Engagement, Market Access, RWE and Clinical) will join healthcare innovators on their yearly journey to the 18th eyeforpharma Barcelona Conference. The city is the meeting place where new initiatives find their wings. The conference is how pioneering initiatives…

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Mar 24

Measuring the Impact of Risk Based Monitoring

This webinar took place on March 24, 2020. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. The RBM initiative was one of the first for TransCelerate. It released 8 methodology framework papers and multiple supporting tools and resources. The perception currently is that RBM…

Virtual Group 33
Mar 16

Patients as Partners

Bringing Value Back to Patients: Applying Patient Engagement Initiatives and Demonstrating Impact The 7th annual Patients as Partners is guided by a dedicated group of advisors from pharma and biotech, patient advocacy and FDA whom meet quarterly to develop the conference agenda. This is the only event that truly demonstrates how to involve patients throughout the entire…

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Mar 15

Society of Toxicology Annual Meeting

Taking place in Anaheim, California, the SOT 59th Annual Meeting and ToxExpo will feature more than 80 Scientific Sessions, 2,000 presentations, 300 exhibitors, and 6,000 attendees.

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Mar 9

TransCelerate Hackathon: Digitizing Clinical Study Design

The TransCelerate Digital Data Flow initiative (DDF) will conduct a virtual Hackathon from March 9 to April 7 to: Evaluate feasibility of the published Solution Framework and Conceptual Design Assess vendor readiness to build such a solution, and bring visibility to DDF During the Hackathon, multiple vendors will develop technical demonstrations of components of a…

TransCelerate Hackathon Group 33
Feb 20

Digital Data Flow: Announcing the 30-Day Virtual Hackathon

This webinar took place on February 20, 2020. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. The TransCelerate Digital Data Flow initiative (DDF) will conduct a virtual Hackathon in spring of 2020 to: Evaluate feasibility of the published Solution Framework and Conceptual Design; Assess vendor…

Virtual Group 33
Feb 18

Scope Summit 2020

TransCelerate BioPharma will be in attendance and represented by the following speakers: Tuesday, February 18 12:05 PM: Change Management Clinical Supply Chain Considerations for Digitally Enabled Patient-Centric Clinical Trials, Matthew Moyer (Merck) Wednesday, February 19 11:35 AM: An Exploration of Effective Regulator Engagement Regarding the Use of Digital Endpoints Suraj Ramachandran (Merck) 2:20 PM Strengthening…

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Feb 11

An Overview of TransCelerate’s Clinical Trial Registration Tool

This webinar took place on February 11, 2020. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. TransCelerate’s Clinical Research Access Initiative took on the challenge to improve the quality of the data in the public domain on clinical research options. One of the largest…

Virtual Group 33
Jan 31

Global Oncology Site Summit

The SCRS Global Oncology Site Summit is the best place for sites, sponsors, and CROs to come together to learn, communicate and collaborate in ways that will truly propel cancer research to a new level. The meeting provides tremendous value to attendees by providing educational tools, networking opportunities and creating partnerships and relationships between sponsors,…

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Jan 27

Patients as Partners Europe

The 4th annual Patients as Partners EU is the first European event dedicated to understanding how industry can work with patients and caregivers to drive greater clinical trial efficiencies. TransCelerate BioPharma will be in attendance and represented by the following speakers: Sherina Kuruvilla, Associate Project Director, Global Patient Relations, Novo Nordisk

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Jan 21

CROWN Congress 2020

The 9th CROWN Congress is the leading industry event to discuss clinical operations challenges, trends, and best practices. By deep diving into the role of the clinical professional, we will touch on relevant topics such as disruptive technology, data management, regulation overview, and the effects that the operations role has on clinical trials.

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Nov 19

Partnerships in Clinical Trials Europe

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Nov 6

How to Make Clinical Trials Patient-Centric: An Overview of TransCelerate’s Study Participant Feedback Questionnaire (SPFQ) Toolkit

This webinar took place on November 6, 2019. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. Although clinical study sponsors recognize the importance of partnering with patients to create better experiences for clinical study participants, caregivers, and families, they do not always have the…

Virtual Group 33
Nov 5

Transforming Clinical Trial Start Up with Digital Data Flow: A Solution Framework and Hackathon

This webinar took place on November 5, 2019. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. The TransCelerate Digital Data Flow (DDF) Initiative was launched in 2018 with the primary objective of encouraging and facilitating a pathway to digitize the clinical study startup process.…

Virtual Group 33
Nov 4

How to Make Clinical Trials Patient-Centric: An Overview of TransCelerate’s Patient Protocol Engagement Toolkit (P-PET)

This webinar took place on November 4, 2019. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. Although clinical study sponsors recognize the importance of partnering with patients to create better experiences for clinical study participants, caregivers, and families, they do not always have the…

Virtual Group 33
Oct 23

Protocol Deviations Management Toolkit: Seeking Public Feedback

This webinar took place on October 23, 2019. You can watch a recording of the webinar on our YouTube Channel and download a PDF of the presentation. This free webinar educates participants on the work done by our Protocol Deviations Initiative, and invite them to review and comment on the draft Protocol Deviations Management Toolkit.…

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