Transforming Pharmacovigilance: Solutions to Solve Regulatory Challenges

Patient safety depends partly on sponsor organizations’ compliance with pharmacovigilance (PV) regulatory requirements—even when global variations exist. Helping sponsors interpret and operationalize challenging PV regulations and guidances is the goal of TransCelerate’s Interpretation of Pharmacovigilance Guidances & Regulations (IGR PV) initiative.

In this third installment of our IGR PV blog series, we will examine the solutions delivered by the IGR PV team, explain the reasons for their creation, and discuss their critical importance. 

Delivering tangible answers for tough topics

The IGR PV team’s mission is to review PV regulations and guidances that may appear ambiguous and then collaboratively determine the best ways to operationalize them. We aim to develop tangible and implementable solutions to harmonize PV regulations globally.

To do this, the team purposefully selects specific topics based on prioritizing the biopharmaceutical ecosystem’s critical needs at the time. Current topics being investigated, for instance, include Regulations Governing the Use of Medicines in Pregnancy and Breastfeeding and PV Data from Digital Health Systems.

We have completed several topics over the past few years, and many solutions are now publicly available. For example:

• One of the first topics the team addressed interpreted challenging portions of investigational new drug (IND) safety reporting requirements in the 2015 U.S. Food and Drug Administration’s (FDA’s) Draft Guidance for Industry: Safety Assessment for IND Safety Reporting. The IGR PV team published a perspective paper summarizing TransCelerate member companies’ experience with several areas of the guidance, including the safety assessment committee (SAC), the safety surveillance plan (SSP), anticipated serious adverse events (SAEs), aggregate safety data review, and aggregate and individual IND safety reports.
• Another initiative reviewed the Clinical Trial Facilitation Group (CTFG) Q&A Document on Reference Safety Information (RSI), and discussed various aspects such as the selection of information to include in the RSI, event frequency calculations for events in the RSI, submission and implementation of RSI, use of RSI data in the Developmental Safety Update Report (DSUR), and more. The IGR PV team’s solutions include a manuscript that offers tips for operationalizing RSI requirements.
• More recently, solutions to help companies consider how to address the presentation of safety risks throughout the product life cycle include a framework that maps out regulatory requirements and operational considerations for presenting safety risks at various product stages.

Strengthening PV science

At its core, the IGR PV team aims to contribute to the science of PV to support clinical studies and post-marketing safety with the objective of advancing patient safety. PV considerations form a continuum from clinical trials through post-marketing.Therefore, the team always views every topic it pursues with consideration for bringing the most value and impact from a PV perspective.

Therefore, the team’s function complements TransCelerate’s holistic work. We strive to align with the organization’s mission to collaborate across the global biopharmaceutical ecosystem to create solutions that improve the delivery of new medicines. Our projects will also continue to provide a comprehensive suite of information to ensure the ecosystem has robust ways to conduct clinical trials.   

One of the key benefits of the IGR PV team is that it comprises experts from multiple sponsor companies and various professional backgrounds, including pharmaceutical physicians, physicians, pharmacists, epidemiologists, heads of pharmacovigilance, post-marketing surveillance specialists, and others. Working together rather than separately enables us to share ideas, lessons learned, and best practices as we develop publicly available solutions to benefit the entire ecosystem—and, ultimately, patients.

Celebrating success stories

It has been gratifying to see tangible impacts from the team’s solutions.

For instance, we have witnessed how sharing publications, assessments, presentations, and best practices through the team’s Pregnancy and Breastfeeding topic has already begun helping a historically underserved patient population. One sponsor company streamlined its “Clinical and Post-market Pregnancy Follow-Up” form using the initiative’s Pregnancy and Breastfeeding Landscape Assessment.

We also know that sponsor companies have used the team’s RSI solutions to shape their RSI processes more confidently. In addition, invitations to speak and lead training sessions at large conferences such as the DIA Global Annual Meeting and DIA Europe show that the ecosystem seeks information about our IGR PV solutions.

Equally important, however, are collaborative efforts between the IGR PV team and regulators. As PV regulations grow increasingly complex, it’s vital that we cooperate not just with other sponsor companies but also with other industry consortia and regulators. Some regulators — including the FDA — have asked the team for their perspective on upcoming guidances.

We are encouraged to see the PV field move toward more complementary and collaborative endeavors.

Ultimately, if we do a good job of engaging each other and health authorities to better interpret and comply with PV regulations, we will improve the delivery of new medicines and enhance patient safety.

To learn more about the work of our IGR PV team, stay tuned for upcoming blogs in our IGR PV series.

To access our entire suite of IGR PV solutions, see our solutions page.

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