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July 10 2024
July 17 EMA Webinar on New Pilot Programs Offering Consolidated Scientific Advice

The European Medicines Agency (EMA), in collaboration with the Accelerating clinical trials in the EU (ACT EU) initiative, will host a webinar on July 17th regarding its two new consolidated scientific advice pilot programs. The pilots enhance the coordination within the European medicines regulatory network (EMRN) to offer applicants harmonized advice on how to improve the quality of their applications for marketing and/or clinical trial authorization(s).

TITLE: CT EU consolidated advice pilots: information and training webinar for Applicants.

WHEN: Wednesday, 17 July 2024, 15:00 – 17:00 CEST / 9:00 – 11:00 am EDT

WHAT: The webinar will cover the background, benefits, and scope of each pilot. Key actors will be introduced, such as the Clinical Trial Coordination Group(CTCG) and Scientific Advice Working Party (SAWP). There will be an opportunity for Q&A and feedback from stakeholders.

PILOT PROGRAMS:

– Pre-CTA: Provides consolidated advice from the National Competent Authorities (NCA) of the EU Member States regarding regulatory and technical aspects of clinical trials.

SAWP-CTCG: Provides consolidated advice on both clinical trial evidence requirements (NCA remit) and marketing authorization evidence requirements (centralized scientific advice remit).

These programs are a great opportunity for sponsors. EMA is accepting applications now.