EVENT | DIA RAPS Regulatory Policy Forum

Many key takeaways and highlights from the DIA RAPs Regulatory Policy Forum!! Capitalizing on the success of their joint collaboration this past January for 2024 Combination Products in the EU, DIA and the Regulatory Affairs Professionals Society (RAPS) are coming together once again to produce the 2024 Regulatory Policy Forum. Designed specifically for regulatory policy leaders, senior decision makers, and regulators across the pharmaceutical community, this summit will explore the new EU pharmaceutical legislation and how it will shape the future of the pharmaceutical arena—including research, development and manufacturing—in Europe for decades to come.

Many key takeaways and highlights from the DIA RAPs Regulatory Policy Forum!! Capitalizing on the success of their joint collaboration this past January for 2024 Combination Products in the EU, DIA and the Regulatory Affairs Professionals Society (RAPS) are coming together once again to produce the 2024 Regulatory Policy Forum. Designed specifically for regulatory policy leaders, senior decision makers, and regulators across the pharmaceutical community, this summit will explore the new EU pharmaceutical legislation and how it will shape the future of the pharmaceutical arena—including research, development and manufacturing—in Europe for decades to come.
December 4, 2024

It has been an incredibly insightful experience for Asphalion’s experts Lidia Cánovas, Helen Chen and Imma Ferrera to engage with key stakeholders involved in shaping the new general pharmaceutical legislation, learn from industry perspectives, and delve into discussions shaping the future of healthcare regulation in Europe at the DIA RAPS Regulatory Policy Forum in Brussels this week.

Our experts have been able to participate in the main conclusions from roundtable sessions and in dynamic panels with leading stakeholders.

Furthermore, they have been able to dive deep into the New General Pharmaceutical Legislation (GPL), participating in interactive roundtables focused on:

  • The Paediatrics elements within the GPL
  • Orphan medicines and defining (high) unmet medical needs
  • Europe’s evolving role in global expedited pathways—OPEN, PRIME, and MAA assessment timelines
  • The interface between Scientific Advice and Health Technology Assessment (HTA)

 

We are excited to continue contributing to these important conversations and supporting the evolution of pharmaceutical regulation. Thank you to everyone involved in this fantastic event!

Need help for your regulatory endeavours? Contact us! [email protected]

 

Search News & Events

  • Filter by category

Share

Related news and events

NEWS | EMA New Fee Regulation effective January 2025

The European Medicines Agency (EMA) charges fees for the services it provides. As of 1 January 2025, EMA’s fees are governed by Regulation (EU) 2024/568. This is known as the ‘New fee regulation’. Current rules apply still apply until 31 December 2024.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting