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Hosted Session/Non-CE: Case Study hosted by ClaroPV: Building Effective Cross-Functional Partnerships to Strengthen Pharmacovigilance Compliance
Session Chair(s)
Invited Speaker
, Switzerland
Effective cross-functional collaboration has become increasingly important for Marketing Authorization Holder (MAH) organizations to meet evolving regulatory requirements. The revised GUI-0102 Good Pharmacovigilance Practices (GVP) Guidelines highlight specific areas where collaboration across functions is essential to ensure GVP compliance. This session will explore how Pharmacovigilance,?Regulatory Affairs, Quality and Compliance, Medical Affairs, and other functions can work together to establish effective processes and support GVP requirements. Key cross-functional processes and activities, including label updates, Terms and Conditions, Risk Management Planning, Notification of Foreign Actions, quality and compliance activities, and business continuity planning, will be explored through practical examples and lessons learned.
Learning Objective :
Learning Objectives: - Understand the importance of cross-functional collaboration in meeting regulatory requirements.
- Identify the roles and responsibilities of key functions in supporting GVP compliance.
- Explore practical approaches for establishing effective cross-functional processes and communication pathways.
- Recognize common implementation challenges and strategies to improve collaboration across the MAH organization.
Speaker(s)
Agnes Jankowicz, MS
Vice President Pharmacovigilance and Medical Information, ClaroPV Services Inc, Canada
Ricardo Pasquel Cook, MD
Safety Team Lead, Pfizer Inc., Canada
Patricia Rita Smith, PhD, RAC
Regulatory Affairs Manager, Otsuka Canada Pharmaceuticals Inc, Canada