Events: detail
European Regulatory Procedures & Standards for Pharmaceuticals
- Hosted by:
- Management Forum
- Speaker:
-
Dr Hugh Delargy, Hugh Delargy Associates, UK
Dr Michael Robertson, European Regulatory Affairs, Pharmaceutical Quality Matters, UK
Dr David Snodin, PAREXEL Drug Development Consulting, UK
- Starts:
- March 21, 2007 at 09:00 am
- Ends:
- March 23, 2007 at 05:45 pm
- Location:
- Harrington Hall Hotel, 5-25 Harrington Gardens, London, SW7 4LJ United Kingdom
- Maps:
Description
This course aims to fit in all the regulatory essentials for successful outcomes to applications for marketing authorisations (MAs). If you can only spare 3 days out of the office, then this is the course for you.
There will be a wide coverage of the various European regulatory procedures, some being open to companies to select and others being compulsory to follow.
This course will also be focused on data and documentation essential requirements for the registration dossier and its maintenance, regarding clinical, non-clinical and pharmaceutical (chemistry, manufacturing and control, CMC topics). The course is relevant for all types of MA dossiers, ‘full’ and ‘abridged’, whether they concern new drug substances, biologicals or existing active substances including line extensions and generics.
- Registration required:
- Yes
- Free:
- No
Additional information
21 March 2007
08.30 Registration & Coffee
Start 09.00 – Finish 17.45
Drinks Reception Start 17.50 – Finish 18.50
22 March 2007
Start 08.30 – Finish 17.45
23 March 2007
Start 08.30 – Finish 15.30
Conference Fee
£1,750 + 17.5% VAT. The fee includes course documentation as well as mid-session refreshments and lunch. Invoice and confirmation will be forwarded to you.
Discounted Rates
Available on application for personnel from non-profit making organisations and registered charities. Group discount available on request.
For more information
- Contact person:
- Management Forum office
- Phone:
- 01483 730071
- Email:
- registrations [ at ] management-forum.co.uk
- Website:
- European Regulatory Procedures & Standards for Pharmaceuticals
