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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
Necessary documentation is required for an effective and successful implementation of reliance mechanisms, considering the concept of risk prioritization in decision-making processes for marketing applications. The appropriate use of documents such as Public and Unredacted Assessment Reports, and Certificates of Pharmaceutical Products (CPP), among others will be shown. 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. 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 models
- Explore decision-making practices necessary for the practical implementation of reliance models
- Clarify the concept of "sameness" in the context of regulatory agencies and outline the essential documentation required
- Examine the broader scope of reliance models, going beyond their applications in marketing authorizations
Speaker(s)
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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