Mergers and acquisitions are essential for portfolio growth, but they often result in fragmented Pharmacovigilance environments. Following an acquisition, organizations often inherit multiple PV systems, disparate local processes, and diverse operating models designed for regional needs rather than unified global oversight. Without a structured integration strategy, these complexities can increase compliance risk, operational burden, and barriers to scalability.
Key Takeaways
- The Critical Role of PV Due Diligence: Understand how robust PV due diligence identifies regulatory, compliance, and operational risks early in the M&A lifecycle; enabling informed decision making and proactive mitigation strategies
- Building a Global PV Framework with Local Flexibility: Learn best practices for establishing a global pharmacovigilance framework that accommodates local regulatory requirements.
- Strategies for Structured PV System Integration: Explore strategies for structured integration of complex PV systems to reduce fragmentation, strengthen oversight, and maintain global regulatory compliance during the transition phase.
- Benefits of a Phased Go Live Approach: How a phased go live approach minimizes operational risk, enabling controlled migrations, end to end setup, and inspection-ready processes.
- Lessons Learned from Post Merger PV Challenges: Identify common pitfalls organizations face after acquisitions and gain practical guidance to prepare your PV organization for future M&A activity with greater agility and resilience.
This webinar session will explore how organizations can transform fragmented PV landscapes into cohesive, compliant, and future ready global PV models. Participants will get practical insights into best practices for PV Integration during Merger and Acquisition.
About the Speaker:
Dr. Vineet Kacker Ph.D.
Managing Director and Global Technical Head
Dr. Kacker holds a PhD in Pharmacology from the All India Institute of Medical Sciences (AIIMS), India. He brings more than 26 years of experience in global Regulatory Affairs and Pharmacovigilance. He serves as a Qualified Person for Pharmacovigilance (QPPV) across several multinational organizations, playing a key role in establishing, strengthening, and overseeing global pharmacovigilance systems.
He is a co‑founder of APCER Life Sciences and currently serves as Managing Director and Global Technical Head of the organization. In this capacity, he provides scientific and regulatory leadership for the development, implementation, and continuous improvement of global compliance systems for clients. Dr. Kacker is a Life Member of the Indian Pharmacological Society and an active member of the Organization for Professionals in Regulatory Affairs (TOPRA) and the Research Quality Association (RQA).