Associate Director, Global Pharmacovigilance Operations,
Takeda Global Research & Development Center Asia Private Limited
13:00 Roundtable A: Negotiating PV Timelines: Closing the Gap between Company SOP and Local Regulation
15:45 Exploring Long-Term Strategies in Developing Core PV Processes: Outsourcing vs. Capacity Building
•Discussing Asia’s strategic shift from outsourcing to innovation in research and development
•Discovering opportunities and overcoming obstacles in building core PV processes in various parts of Asia.
•When is it more justifiable to internalize PV functions?
•Ensuring smooth transitions: how and when should one re-integrate outsourced functions into the company?
Merger and acquisitions are increasingly on the rise in the pharmaceutical and bio-technology industry. Done out of financial or business reasons, PV is often considered as afterthought and may be addressed late in negotiations on post-conclusions, at the risk of compliance or safety:
• How do you overcome operational challenges and manage the switch in ownership?
• Ensuring safety systems continue uninterrupted and that PV functions are carried out in a timely manner
• The role of the QPPV in ensuring a clear transition of responsibilities and the maintenance of activities
• How is compliance assured across multiple databases?
• Determining that all safety exchange agreements in place and valid