CRED 8 Presentations

03/07/2024

CRED Navigating European Regulatory Procedures

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CRED Navigating European Regulatory Procedures – 11-12 July 2024 Developing Strategy for Non-NCEs

12-13 th March 2020

Eesha Vyas, Oncology Regulatory Lead, GSK

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes

This session is intended to give the delegates an overview of developing their strategy for non-NCEs, in Europe

Key points to be covered:

● Understand the legal basis, and the complexities involved when considering the Regulatory Strategy for:

• Bibliographic/ Well Established Use • Line extensions/generics/hybrids • Biosimilars • Borderline and Combination Products • Herbals

The Organisation for Professionals in Regulatory Affairs

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