Date(s) And Time(s):
Jul 4 2011 7:00AM - Jul 6 2011 4:00PM
Radisson Blu Hotel, Tallinn, Estonia
This 3-day workshop will highlight the benefits of the ICH (1) Common Technical Document (CTD) for manufacturers and regulators. Harmonisation of regulatory requirements and high quality of a registration dossier facilitate the registration procedure and are essential for both generics as well as innovative medicines. A comprehensive description of the CTD structure will be provided by an expert faculty from regulatory agencies and industry. The workshop will focus on the specific regional EU (European Union) requirements taking into account the recent ICH-Q guidelines.
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)
• Gain practical knowledge about the CTD format of dossiers and ways to its implement them. The
focus will lie on Modules 2 and 3.
• Understand the steps to be followed in CTD implementation
• Learn how to develop and maintain a registration dossier in CTD format
• Find guidance on the content of the most important parts of the CTD (guidelines)
• Understand the regulatory work with a dossier in CTD format
• Learn about assessment report writing
• Gain basic knowledge of the electronic CTD (eCTD)
• 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
The DIA Europe Customer Services Team will be pleased to assist you with your registration.
Please call us on +41 61 225 51 51 from Monday to Friday between 08:00 and 17:00 CET.