Regulatory Affairs - EMA - Marketing Authorization Applications for Pharmaceutical Products in EU. Peivand Pirouzi, Ph.D.

In this video, Professor Peivand Pirouzi provides an in-depth explanation of the Marketing Authorization Application (MAA) process for pharmaceutical products in the European Union (EU). The European Medicines Agency (EMA) plays a central role in regulating and approving medicinal products in the EU, and understanding the steps involved in submitting an MAA is crucial for pharmaceutical companies and regulatory affairs professionals.

Key topics covered include:

An overview of the EMA and its role in the marketing authorization process.
A detailed look at the Marketing Authorization Application (MAA) and the documents required for submission.
How to navigate the application process, from preparing the dossier to interacting with regulatory authorities.
Key requirements for demonstrating the quality, safety, and efficacy of pharmaceutical products in the EU market.
The importance of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other regulatory standards during the submission process.
Common challenges faced during MAA submissions and strategies for a successful outcome.

This video is an essential resource for pharmaceutical professionals, regulatory affairs specialists, and anyone interested in the EU drug approval process. Whether you’re preparing for your first MAA submission or seeking to improve your understanding of the process, this video offers valuable insights into the EMA’s procedures.