Clear strategy, compelling argument and well-rehearsed preparation are the keys to winning at an EMA meeting, no matter if it is a Scientific Advice meeting or a CHMP meeting. In this webinar, we will use CHMP meeting as an example to walk you through the complex processes and share insights on the preparation, for you to get the best out of the EMA meetings.Register Now
Peri Aghadiuno, MBBS, MRCOG
As a Medical Director at VCLS, Peri is responsible for providing input to, and critical review of, the clinical sections of a variety of documents, including client clinical development plans, ODD, PIP and PRIME briefing documents. She also plays a crucial role in identifying questions to be raised with Regulators as part of the requests to EMA, National Agencies and Joint EMA-HTA bodies for scientific advice, and in critically reviewing the advice received.
Eugenio Fernandez Alanis, Ph.D., M.Sc.
Senior Regulatory Scientist, Regulatory Science
Eugenio provides support to both the Drugs & Biologics and Complex Biologics teams. His roles include conducting research, drafting deliverables – in particular projects requiring scientific writing, coordinating regulatory submissions, and interacting with Regulatory Agencies.
Frédéric Pailloux, Pharm.D. M.Sc.
Senior Director, Regulatory Science, Drugs & Biologics
Frédéric is an enthusiastic Regulatory Scientist with 16 years of experience in the pharmaceutical industry. He has extensive experience in coordinating all aspects of Centralized submissions to the European Medicines Agency, and of Decentralized/Mutual Recognition procedures to EU National Health Authorities, from pre-filing dialogue stage to grant of marketing authorizations and beyond.