This article, the second in a two part paper highlights the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.
June 2015 - Regulatory Rapporteur
Frédéric Pailloux, Senior Director Regulatory Science Drugs & Biologics
He is in charge of design and implementation of global regulatory strategies for the development, evaluation and marketing of small molecules and biologics.Frederic is an enthusiastic Regulatory Affairs expert 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.
Nathalie Boeglin, Director Regulatory Science Drugs & Biologics
Nathalie assists clients in the design of global products development plans and associated regulatory strategies. She has extensive experience in interactions with the European Medicines Agency (EMA) and national European Health Authorities, in particular for scientific advices and Marketing Authorisation Applications (MAA).
Alice Rolland, Regulatory Scientist Drugs and Biologics
Alice has been involved in numerous projects on Life Cycle Management, Market Authorisation Applications in Europe and in the United States, Scientific Advices – national as well as at the EMA –, Orphan Drug Designations and in Regulatory Strategies for the development of drugs and biologics.
David Uguen, Executive Director Drugs and Biologics
David Uguen is responsible for the management of projects involving the design and implementation of regulatory strategies for the development of drugs and biologics. David gained a 18-year experience in European regulatory affairs applied to the development, registration and maintenance of both pharmaceutical and biotechnology medicinal products.