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Session 4, Track A: Regulatory Reliance Initiatives, Lessons Learned, and Best Practices
Session Chair(s)
Susan Koepke, MBA
Head of Regulatory Affairs LATAM
EMD Serono, Inc., United States
Diego Alexander Salas, LLM
Regulatory Affairs Director
FEDERACION LATINOAMERICANA DE LA INDUSTRIA FARMACEUTICA, A.C., Mexico
Attendees will gain insights on how to ensure ‘product sameness’ and discuss all relevant aspects to be considered, for example, same qualitative and quantitative composition, strength, pharmaceutical form, intended use, manufacturing process, suppliers of active pharmaceutical ingredients, and quality of excipients. The use of documents such as Public and Unredacted Assessment Reports and Certificates of Pharmaceutical Products (CPP) as tools to guide reliance decision-making by regulatory agencies will be discussed. Additionally, the scope of reliance beyond marketing applications, sharing how local practices related to the testing of pharmaceutical products are changing with the use of reliance will be discussed.
Learning Objective : - Gain insights on risk prioritization in decision-making
- Explore decision-making practices necessary for the practical implementation of reliance models
- Clarify the concept of "sameness of product" and outline the essential documentation required for effective reliance implementation
- Examine the broader scope of reliance models, going beyond their applications in marketing authorizations
Speaker(s)
Tools to Facilitate the Use of Reliance and the Importance of Sameness of Product
Sérgio Cavalheiro Filho, MPharm
IFPMA, Switzerland
Manager, Regulatory Affairs
Appraisal of Public Assessment Reports (PARs) as Tools to Guide Reliance Decision-making by Regulatory Agencies
Juan Ramón Lara
Centre For Innovation In Regulatory Science, Mexico
Senior Research Analyst
How reliance is changing local practices related to testing of pharmaceutical products
Joerg Garbe, PhD, MSc
F. Hoffmann-La Roche Ltd, Switzerland
Global Quality Manager & Policy Lead
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