RAPS Chicago Chapter: CHMP Meetings: How to Prepare for, Manage and Excel at EU Regulatory Meetings

Getting a product approved by the European Medicines Agency (EMA) can be daunting, especially for companies that have little experience with this unique and complex process. Within EMA, the Committee for Medicinal Products for Human Use (CHMP) conducts a scientific data review and recommends whether or not the drug or biologic should receive marketing authorization. CHMP holds meetings to get input and scientific advice to inform its decision and/or to discuss objections that might prevent or delay approval. For applicants, the goal is clear: get a positive majority vote for marketing authorization. However, multiple hurdles exist that can make preparing for these meetings quite challenging.

This presentation will walk you through how to prepare for, and manage, CHMP meetings to achieve a positive recommendation for your product. Upon the presentation’s conclusion attendees will:

• Understand the EMA review timeline
• Learn how to prepare for the four different types of CHMP meetings you may face (Expert Group meeting, Scientific Advisory Group (SAG) meeting, Oral Explanation and PRAC meeting)
• Be introduced to the technology and support needed to successfully manage Q&A in the meetings

This program is brought to you by the RAPS Chicago Chapter and is intended to promote knowledge sharing and engagement with others in the local regulatory community. Dinner will be provided and RAC holders may claim two RAC recertification credits.