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Operationalizing Patient Safety: An Overview of TransCelerate’s Interpretation of PV Guidances & Regulations Initiative

For the second installment of our Interpretation of Pharmacovigilance Guidances & Regulations (IGR PV) Initiative blog series, we will take a deep dive into the initiative and its goals.

Established in 2018, this initiative germinated when it became apparent that some of the regulations issued by global Health Authorities can be unclear and/or challenging for sponsors to implement. As a result, each company was trying to interpret and operationalize new drug safety guidance on its own, which resulted in various degrees of interpretation and execution. It is challenging to meet Health Authority expectations and comply with these ambiguous regulations and guidances. To help overcome these challenges, TransCelerate believed that compliance efforts would greatly benefit from a mechanism that would allow Marketing Authorization Holders to learn how other organizations were tackling the same problems and compare processes to fully understand Health Authority expectations.

Setting up for success

It made sense for TransCelerate to establish a new initiative for Member Companies to collaborate and identify those regulations that were considered the most ambiguous, discuss the various potential interpretations, and then raise awareness of these elements in the greater drug safety ecosystem. An opportunity existed to share experiences about common barriers and provide relevant points to consider regarding various approaches for understanding and operationalizing regulatory expectations.

Through TransCelerate, participating Member Companies could propose solutions that would help not only Member Companies but the entire PV ecosystem by making the resulting solutions publicly available. These solutions identified the common pain points and offered options for ways to operationalize the guidance within those organizations adopting the solutions.

One of the core strengths our team takes pride in is that there are multiple professional backgrounds from the collective minds of the top R&D companies in the world represented on the team, allowing for a broad range of perspectives on topics and helping to achieve thoughtful outcomes. The TransCelerate IGR PV team includes pharmaceutical physicians, post-marketing surveillance experts, heads of pharmacovigilance, and scientists specialized in regulatory intelligence, safety operations, and PV requirements in clinical development.

When selecting a new topic, the team identifies a short list of guidances that might be good candidates for the team’s focus. Through a deliberative process, one will be chosen to be the next IGR PV Initiative. Once the topic is selected, TransCelerate sources Member Company experts in those areas to lead the team and identify other experts within their companies that would provide the most relevant input. From there, the team isolates the ambiguities and starts to create approaches to address them.

Global guidances explained

Our first IGR PV topic was from the U.S. Food & Drug Administration (FDA) 2015 guidance on Safety Assessment for IND Safety Reporting. The next topic was from Europe, focusing on the 2017 Clinical Trial Facilitation Group Q&A on Reference Safety Information, and the team quickly followed that release with the production of an implementation guide and webinar focused on interpreting areas of the FDA’s Postmarketing Safety for Combination Products Draft Guidance.

Initially, the initiative spanned both clinical and pharmacovigilance regulations. In 2021, it became apparent that there was enough need to warrant the establishment of two TransCelerate initiatives, one dedicated to clinical guidance and one dedicated to pharmacovigilance guidance. TransCelerate’s solutions are developed to identify or develop approaches for users navigating these new challenges in an effort to help companies comply with regulatory expectations in a more efficient and effective manner.

The IGR PV team broadened the scope to address a challenge faced by most companies working globally. This resulted in the topic team creating a Safety Issue Notification Guide identifying various approaches to meet Health Authority expectations in Australia, Canada, Israel, New Zealand, Saudi Arabia, Switzerland, and Turkey. This was followed by a topic team developing a Framework on the Presentation of Safety Risks throughout the Product Lifecycle, which helps companies better understand how regulators define risks during different stages of a drug life cycle from key guidances such as Good Pharmacovigilance Practices (GVP) and the International Council for Harmonisation (ICH), and describes how to present key safety risks in safety and regulatory documents in a manner which complies with these guidances.

More recently, the topics evolved even further and focused on significant areas in which ambiguity and inaction have resulted because the regulatory landscape is relatively sparse and is evolving or needs to evolve further. The first of these focused on global regulations governing the use of medicines in pregnancy and breastfeeding. The team provided a suite of solutions, including a landscape assessment and a landscape comparison by regulation, a paper outlining points to consider when considering this topic, and an infographic. More details on TransCelerate’s pregnancy and breastfeeding initiative can be found in our recent blog post on the topic.

Our most recent topic team created a glossary and reference resource library focused on PV Data from Digital Health Systems: Regulations, Implications, and Opportunities. Given the relatively sparse regulatory guidance addressing pharmacovigilance compliance to help pharmaceutical companies deal with the growing volume and complexity of safety data potentially available from Digital Health ecosystems, a need obviously exists to clarify regulatory information on digital health, including current terminology and definitions relevant to PV to increase clarity and communication within stakeholders.

Shedding light on global barriers

The points to consider solutions provide organizations with the relevant considerations that companies can assess and thereby significantly advance their efforts to comply with divergent, ambiguous, or sparse Health Authority regulations. The IGR PV Initiative team prides itself in creating tangible, implementable solutions with an aim to better support company processes to fulfill global regulations. Additionally, we use the presentation of our solutions to call for regulators to (re-) harmonize these regulations where possible.

The benefit of our released solutions isn’t restricted to sponsors. TransCelerate meets with global Health Authorities a few times a year to share TransCelerate’s progress across several initiatives and identify ways to collaborate. As our solutions are developed, TransCelerate can use these insights in our conversations with regulators to present cross-company feedback. Some of this feedback is used by Health Authorities to revise future iterations of the guidance. After six years of the TransCelerate IGR PV Initiative, regulators have become increasingly willing to engage with us for feedback.

Over the years, TransCelerate’s IGR PV topics evolved to tackle drug safety guidances that have a broader impact across R&D. For example, our March 2023 solution, “Points to Consider Concerning the Use of Medicines in Pregnancy throughout the Product Lifestyle (Based on the Regulatory Guidance across the Globe),” mainly focuses on PV matters, but our observations and identified gaps impact clinical trials operations. Our current Digital Health topic focuses on post-marketing but may also have implications for clinical trials.

It’s been an honor and a pleasure to work with such a talented, diverse, and professional group of colleagues from TransCelerate’s Member Companies, both past and present. We have both learned from participating in this initiative and from other stakeholders and have watched global PV operations change for the better to protect patients.

Check out our solutions page for the latest releases from the team.

Sven Kohler is Vice President, EU-QPPV and Head Regional Patient Safety & Pharmacovigilance at Boehringer Ingelheim. He serves as TransCelerate’s Executive Sponsor on behalf of the Interpretation of Pharmacovigilance Guidances & Regulations Initiative.
Ken Twomey is Senior Director, Oncology Patient Safety at AstraZeneca. He served as the TransCelerate Workstream Lead for the Interpretation of Pharmacovigilance Guidances & Regulations Initiative.

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