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November 12, 2021

From Subject to Superstar: How to Put Patients in the Driver Seat in Clinical Trials (Part 2)

Biopharmaceutical companies and other industry experts have been encouraged to design clinical trials with a keen focus on improving the patient experience. To this end, TransCelerate has created numerous tools, assets, and methodologies to not only help improve the patient experience within current clinical trials, but also with the aim of learning from patient experiences so that future clinical studies can be better designed with the patient’s perspective in mind.

From pre-diagnosis through clinical trial completion, this session will explore several available TransCelerate tools and assets delivered to improve the clinical trial participation journey for patients. This session will also address when to consider utilizing each tool during the patient’s clinical trial participation journey and discuss best practices in the adoption / implementation of these tools.

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November 12, 2021

From Subject to Superstar: How to Put Patients in the Driver Seat in Clinical Trials (Part 1)

Biopharmaceutical companies and other industry experts have been encouraged to design clinical trials with a keen focus on improving the patient experience. To this end, TransCelerate has created numerous tools, assets, and methodologies to not only help improve the patient experience within current clinical trials, but also with the aim of learning from patient experiences so that future clinical studies can be better designed with the patient’s perspective in mind.

From pre-diagnosis through clinical trial completion, this session will explore several available TransCelerate tools and assets delivered to improve the clinical trial participation journey for patients. This session will also address when to consider utilizing each tool during the patient’s clinical trial participation journey and discuss best practices in the adoption / implementation of these tools.

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November 12, 2021

Interpretations of New PV Guidances and Regulations

Historically, there have been challenges in addressing ambiguous regulations / guidance and Health Authority operational expectations. In this session, we will speak about the close collaboration between TransCelerate member companies to understand how each is interpreting and implementing regulations and guidances including: IND Reporting, Reference Safety Information, Postmarketing Safety Reporting for Combination Products, Safety Issue Notifications, IND Safety Reporting to FAERS, and Presentation of Risks Throughout the Lifecycle.

This session will also address best practices across the industry / learnings from feedback from regulators.

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November 12, 2021

Evidence-Based Approach to Improving Drug Safety Activities/Processes

The pharmacovigilance space is ripe for collaboration as the biopharmaceutical industry experiences challenges in drug safety surveillance. In this session, we will speak about the delivered TransCelerate solutions to improve patient safety across the value chain and best practices for implementation. We will address solutions from several TransCelerate initiatives including: Value of Safety Information Data Sources, Interpretation of Pharmacovigilance Guidances and Regulations, Intelligent Automation Opportunities in Pharmacovigilance, and Pharmacovigilance Agreements Optimization.

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November 12, 2021

Symposium Welcome and Leadership Panel

Since 2012, TransCelerate’s mission has been to improve the health of people around the globe by accelerating and simplifying the research and development of innovative new therapies.

In order to fulfill this mission, TransCelerate engages in robust partnerships with organizations across the ecosystem that provide important insights and perspectives that enable us to create value and sustainable industry change.

This leadership panel consists of senior R&D leaders who represent the perspectives of several key stakeholders across the ecosystem.

The panel will address at a high level the importance of collaboration in the future of clinical research and provide real examples of the impact of collaboration being realized today.

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