Integrating global pharmacovigilance (PV) governance with effective local execution is fundamental for consistent and compliant PV operations within complex, multi-country organizational models. Inconsistencies in regional regulations, local processes, and reporting timelines and limited visibility of affiliate and vendor activities often create alignment gaps in global and local PV systems, most notably during fast track transitions, PV handovers, and organisational changes.
This webinar offers a comprehensive view of global-to-local PV alignment, emphasizing the roles, responsibilities, and accountability frameworks that that enable global teams to maintain oversight while supporting consistent local execution. The session features a case study illustrating successful integration of local PV activities into global processes through strengthened governance, harmonized procedures, and compliant local systems.
Ultimately, the webinar demonstrates that clear expectations, robust governance, and sustained engagement between global and local teams are essential to ensuring traceability, accountability, and operational readiness in evolving PV frameworks.
Key Takeaways
- Bridging Global and Local PV: Understand the key expectations for effective alignment between global PV governance and local affiliate execution.
- Leverage Regulatory Intelligence: Explore the pivotal role of robust regulatory intelligence in maintaining compliance across diverse jurisdictions.
- Implement Practical Oversight: Gain actionable insights into oversight mechanisms that enhance visibility of local PV activities, including affiliates and vendors.
Why Attend This Webinar?
- Navigate Complexity with Confidence: Understand how to standardise local procedures in line with global SOPs while respecting regional regulatory requirements.
- Enhance Collaboration: Navigate strategies to foster effective two-way communication between global and local PV teams.
- Drive Compliance Through Clarity: Learn how clear roles, responsibilities, and oversight mechanisms reduce compliance gaps and enhance global-local collaboration.
- Real-World Insights: Dive into a detailed case study showcasing successful integration of local PV activities into global processes through strengthened governance and standardized procedures.
About the Speakers
Dr Kanwalpreet Kaur, MBBS
Qualified Person for Pharmacovigilance (QPPV) and Head of the Strategic Development Group
Dr Kanwalpreet Kaur is a physician by training with over 18 years of experience in clinical practice, healthcare operations, and pharmacovigilance (PV). She brings end to end expertise in PV and clinical safety, including more than a decade of specialised experience in risk management and safety surveillance. Dr Kaur has extensive experience across a broad portfolio of medicinal products, including vaccines, biologics, medical devices, and advanced therapies, spanning multiple therapeutic areas such as cardiology, immunology, and oncology.
Dr Kaur combines strong medical judgement with hands-on proficiency across a wide range of global PV systems and tools. She has played a pivotal role in regulatory inspections and audits, contributing to successful outcomes and ensuring ongoing compliance with global PV requirements. Recognised as a subject matter expert, Dr Kaur has supported global biopharmaceutical organisations through complex PV transitions, delivering optimised PV processes, strengthened inspection readiness, and effective alignment between local and global operating models.
Dr Kaur currently serves as QPPV and Head of the Strategic Development Group at APCER Life Sciences. In this role, she provides strategic medical and scientific leadership and oversees business continuity planning and regulatory intelligence, ensuring proactive monitoring and interpretation of evolving global PV regulations. Dr Kaur is also actively engaged in organisational learning and strengthening capabilities while driving innovation across PV and clinical safety functions.
Binoy Sharma
Vice President, Pharmacovigilance
Binoy Sharma is a seasoned Pharmacovigilance leader with over 18 years of experience across pharmaceutical companies and CROs, with deep expertise spanning the full spectrum of PV domains. Currently serving as Vice President – Pharmacovigilance, he drives both strategic vision and operational excellence in global drug safety, leading initiatives in regulatory compliance and the adoption of innovative technologies.
He works with pharmaceutical organizations to address complex operational challenges across all pharmacovigilance verticals and brings extensive experience in managing major safety databases and systems. Binoy has successfully led large, cross-functional teams and managed complex integrations of QPPV and Local QPPV frameworks, ensuring robust governance and seamless regulatory alignment across regions.
His expertise encompasses end-to-end pharmacovigilance systems, including leading audits and regulatory inspections. Binoy consistently delivers scalable, high-quality safety solutions that strengthen compliance and enhance patient safety outcomes.