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ViewAttendees 10

Pharmaceuticals

Domain: Product Development & Registration

Knowledge Area: Regulatory Guidance

European Expedited Approval Pathways in a Global Context

Friday, May 12, 2023
15:30 – 16:30 CEST
Location: Carmine & Charcoal

Supported By
Description: Many regulatory agencies offer faster or expedited approval pathways for drug approval. This could be for life threatening, seriously debilitating conditions, urgently needed drugs (example Covid-19 Vaccine), or drugs for a particular population (e.g., paediatric, orphan disease).
There is only limited global harmonization for these approval pathways (this will be covered in detail in chapter 31 in the new drugs fundamentals book).
We will address how those expedited pathways in Europe compare with those applied elsewhere. For example, do they cover similar or the same types of drugs, qualifying criteria and features, is the burden for documentation comparable, or are the timelines similar?

Learning Objectives:

  • 1. Upon completion, participants will have an understanding of some key differences of the expedited pathways between Europe and other regions/countries.
  • 2. Upon completion, participants will be aware how information and data required for EU expedited pathways can be leveraged for applications in other regions/countries.
  • 3. Upon completion, participants will be better equipped to define regulatory strategies that include expedited pathways globally.