Joint DIA/WHO Workshop Benefits of the ICH Common Technical Document (CTD)
Venue: Radisson Blu Hotel
|Event Date/Time: Jul 04, 2011||End Date/Time: Jul 06, 2011|
An additional 2-day programme will be provided by the WHO for regulators from 7-8 July.
Presentations will be given in English. Simultaneous translation into Russian will also be provided.
(1) International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (www.ich.org)
â€¢ Gain practical knowledge about the CTD format of dossiers and ways to its implement them. The
focus will lie on Modules 2 and 3.
â€¢ Understand the steps to be followed in CTD implementation
â€¢ Learn how to develop and maintain a registration dossier in CTD format
â€¢ Find guidance on the content of the most important parts of the CTD (guidelines)
â€¢ Understand the regulatory work with a dossier in CTD format
â€¢ Learn about assessment report writing
â€¢ Gain basic knowledge of the electronic CTD (eCTD)
â€¢ Understand the importance of bioequivalence studies
Industry professionals and manufacturers from East European and Central Asian countries relevant for prequalification (PQ) programme, e.g. development managers and professionals in quality assurance / quality management. These professionals are invited to attend the 3-day training course (4-6 July)
Regulatory assessors from National Medicines Regulatory Authorities (NMRA) in East European and Central Asian countries. Regulators are invited to attend the 3-day training plus an additional 2-day programme provided by WHO from 7-8 July