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Session 2, Track A: Navigating Regulatory Reliance: Practical Insights and Applications Beyond Initial Marketing Authorization Application
Session Chair(s)
Daniela Bravo, DrSc, MBA, MSc
Regulatory Policy and Intelligence Latam Associate Director
AbbVie, Brazil
Susan Koepke, MBA
Head of Regulatory Affairs LATAM
EMD Serono, Inc., United States
Regulatory reliance initiatives are increasingly becoming vital in the global landscape, promoting more efficient and harmonized approaches to the approval of medicinal products. While commonly focused on medicines marketing authorization, the scope and benefits of regulatory reliance extend to essential areas such as post-approval changes, Good Manufacturing Practice (GMP) certification, clinical trials applications, medical devices authorizations and local batch release. This session will delve into how expanding reliance beyond medicines marketing authorization can streamline regulatory processes, enhance collaboration among stakeholders and support the timely availability of safe and effective medical products for patients in Latin America.
Learning Objective : - Identify broader applications of regulatory reliance across various regulatory areas
- Describe the regulatory reliance landscape in Latin America, including key challenges and opportunities beyond initial marketing authorization
- Evaluate how regulatory reliance initiatives streamline regulatory processes, contribute to the availability of safe and effective medical products and justify the importance of collaboration among regulatory bodies
Speaker(s)
Efficient Implementation of Regulatory Reliance: An Industry Perspective
Sérgio Cavalheiro Filho, MPharm
IFPMA, Switzerland
Manager, Regulatory Affairs
Speaker
Magda Bujar, PhD, MSc
Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Associate Director, Regulatory Programme and Strategic Partnerships
Navigating Regulatory Reliance: Practical Insights and Applications Beyond Initial Marketing Authorization Application
Augusto Bencke Geyer, MSc
ANVISA, Brazil
Health Regulatory Expert, International Affairs Office
Reliance's Strategic Projection in ANMAT
Andrea Ricchiutti, RPh
ANMAT Ministry of Health, Argentina
Head of the Regulatory Inspction Service