At the recent expert webinar hosted by the Council for the Promotion of International Vaccine Cooperation (CPIVC) under the China Association for Vaccines (CAV), P95 was invited to present regulatory best practices for pharmacovigilance support in global clinical trials.
P95’s presentation, delivered by our Safety Expert, Dr Marc Ceuppens, focused on the responsibilities of sponsors and investigators, highlighting how sound pharmacovigilance systems contribute to both trial integrity and participant safety.
In this blog, we summarize our key insights into regulatory frameworks, regional differences, and how P95 supports pharmacovigilance activities across international clinical studies.
Why pharmacovigilance support is essential in global clinical trials
In the context of vaccine research, pharmacovigilance plays a central role in maintaining participant safety, ensuring regulatory compliance, and strengthening confidence in outcomes.
Whether operating across Europe, Asia, or LMICs, pharmacovigilance support in global clinical trials must be timely, transparent, and tailored to regional requirements. At P95, our goal is to simplify this complexity for our clients.
Regulatory responsibilities: sponsor and investigator roles
P95’s presentation during this webinar provided an overview of responsibilities guided by the ICH E6(R3) Good Clinical Practice guidelines, serving as the foundation for effective pharmacovigilance across diverse jurisdictions.
Investigator responsibilities include:
- Immediate reporting of serious adverse events (SAEs)
- Reporting protocol-defined adverse events and lab abnormalities
- Sharing relevant documentation in cases of participant death
- Complying with local rules for unexpected serious adverse drug reactions (SUSARs)
Sponsor responsibilities are even more comprehensive:
- Regular safety data reviews that assess impacts on study conduct and ethics approvals
- Expedited safety reporting for SUSARs to regulators, ethics committees, and investigators
- Managing immediate hazards to trial participants, including protocol changes, and notifying authorities
Each of these is a core component of robust pharmacovigilance support in global clinical trials, especially in fast-moving vaccine development programs.
Regional requirements: adapting pharmacovigilance across countries
We also addressed the practical implications of region-specific safety reporting regulations, comparing protocols in:
- The European Union, including EudraVigilance reporting and Development Safety Update Reports (DSUR) expectations
- Indonesia, Malaysia, and Thailand, where expedited and periodic reporting standards vary by health authority
Our experience highlights how global pharmacovigilance support depends on local expertise and proactive planning to stay compliant while ensuring participant safety.
How P95 delivers pharmacovigilance support in global clinical trials
As the demand for global vaccine research expands, so does the need for consistent and localized pharmacovigilance. From early-phase planning to post-marketing safety oversight, P95 offers end-to-end pharmacovigilance capabilities tailored to international vaccine and infectious disease trials.
We help sponsors:
- Design protocols with compliant safety frameworks
- Navigate regional regulatory requirements
- Submit expedited and periodic safety reports
- Coordinate data across multiple sites and study teams
- Manage communication with health authorities and ethics committees
This level of pharmacovigilance support in global clinical trials ensures that our clients remain audit-ready and scientifically rigorous, no matter where the trial is run.
Learn more about our pharmacovigilance and regulatory services.
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