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.
Frédéric Pailloux, Pharm.D. M.Sc. Senior Director, Regulatory Science, Drugs & Biologics
Frédéric Pailloux manages projects involving the design and implementation of global regulatory strategies for the development, evaluation and marketing of small molecules and biologics.
Eugenio Fernandez-Alanis Ph.D., M.Sc. Senior Regulatory Scientist, Drugs & Biologics / Complex Biologics
Eugenio providing support to both the Drugs & Biologics and Complex Biologics teams. Eugenio is involved in the preparation of orphan drug designation (ODD) applications in the EU and in the US, as well as the preparation of Paediatric Investigation Plans (PIP) and the authoring of Briefing documents for Scientific Advices. He also provides recommendations on the feasibility of these applications and on the strategy to develop to meet Agencies’ expectations.
Peri Aghadiuno, MBBS, MRCOG, Medical Director
Peri is a Medical Director with VCLS, She provides input into the drafting and critical review of clinical development plans including prospective drafting and gap analysis); critical review of clinical parts of EMA Scientific Advice, National Scientific Advice and Joint EMA-HTA bodies Scientific Advice briefing documents; responses to issues raised (by CHMP/National regulators)and corresponding presentations, critical review of clinical parts and significant benefit sections of ODD briefing documents and PIP briefing documents and the rehearsal of client presentations on clinical regulatory perspective for oral explanations when required.