Overview

This Solution Provider Webinar is brought to you by DIA in cooperation with

Sciformix

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 the 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. This presentation will walk you through how to prepare for, and manage CHMP meetings to achieve a positive recommendation for your product.

Continuing Education Credits are not available for this event.

Featured topics

Prepare for and manage CHMP meetings to achieve a positive recommendation for your product
Overcome CHMP objections within a limited timeframe
Ensure voting participants retain information up until the vote

Who should attend?

Professionals who work in the area of:

US regulatory
EU regulatory
Clinical Development

Learning objectives

At the conclusion of this webinar, participants should be able to:

Define the EMA review timeline
Evaluate 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)
Assess technology and support needed to successfully manage Q&A in the meetings

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