Single registrationBuy Now
Why you should attend ?
Scientific advice is when the Regulatory Authorities gives advice to a company on the appropriate tests and studies in the development of a medicine. This is designed to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients.
Choosing the right procedure for scientific advice (at the European Medicines Agency or at the National Authorities in the EU) and preparing well for the procedure is very important to assure your development program meets the requirements of the Regulatory Authorities.
In addition, the European Medicines Agency offers scientific advice to support the qualification of innovative development methods for a specific intended use in the context of research and development into pharmaceuticals.
The advice is given by the Committee for Medicinal Products for Human Use (CHMP) on the basis of recommendations by the Scientific Advice Working Party (SAWP). This qualification process leads to a CHMP qualification opinion or CHMP qualification advice. The procedure will be explained, as well as when it is best to use this procedure.
Sometimes it is useful to request scientific advice and protocol assistance in parallel with the United States Food and Drug Administration or with health-technology-assessment (HTA) bodies.
The aim of parallel scientific advice with HTA Bodies is to allow medicine developers to gain feedback from regulators and HTA bodies at the same time, early in the development of a medicine. This helps them to establish the evidence that both parties will need to determine a medicine's benefit-risk balance and value.
This webinar will address which procedure is best depending on the circumstances (centralized or national), and how to choose among the National Authorities in the case of national scientific advice. It will also address the inclusion of HTA bodies in the scientific advice procedure. In addition, it will cover the preparation of the meeting (including briefing document).
Areas covered in this webinar
·Scientific advice at the EMA
·Qualification of novel methodologies
·Parallel scientific advice: EMA and FDA
·Parallel scientific advice: EMA and HTA bodies
·National scientific advice
Who will benefit?
Regulatory Affairs personnel, Clinical Development managers and personnel, Project Managers
Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands. He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004, he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003, he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet, he has worked for four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom. He joined the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was Regulatory Affairs Project Manager in the Oncology group in 1996 and 1997. Before 1996, he was Head of Drug Regulatory Affairs for six years at Ciba-Geigy in the Netherlands and has worked as Manager Regulatory Affairs at Glaxo, also in the Netherlands