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Pharmaceuticals

Supply Chain/Shortage

Wednesday, May 8, 2024
11:45 – 12:45 CEST
Location: A 05 + A 06
Learning Level: Intermediate

Description: The EU and its pharmaceutical market regulations are unique in many ways. Not merely a union of many individual member states and organisations, but also unique supply chain models, such as parallel trade (PT). Yet, the EU faces supply challenges as do other countries and regions globally. EMA and the EC are addressing these challenges.

This session explores how regulatory affairs professionals can and should engage with and support the EU’s initiatives for an improved supply chain, and how these benefits could be applied to other regions globally.

Questions to be discussed in this session include:
- Accessibility to drugs is a key objective, but are there sufficient safeguards in place to safeguard patient safety?
- How can regulatory affairs professionals be supporters and enablers of the EU’s initiatives for improved supply security and patient access to drugs?

This session illuminates the disparity between aspiration and reality concerning the single medicine market, advocating for a multi-stakeholder approach to effectively combat drug shortages.

Learning Objectives:

  • Understand the regulatory challenges of the European supply chain in the context of regulatory affairs
  • Gain insights into the complex dynamics of pharmaceutical supply chains, particularly parallel trade
  • Learn what benefit collaborative and communicative relationships among supply chain stakeholders, including regulatory affairs, have and how they can support the EU’s supply chain improvement initiatives.