Regulatory Rapporteur September 2010
- NORTH AMERICA’S REGULATORY LANDSCAPE
- FDA’s electronic submissions gateway
- Primary IND applications
- Due diligence
- Canada update
- PLUS:
- Patient follow-up on gene therapies
- Report on the veterinary products sector
- The current status of biosimilars
- Interview: Prof Kent Woods, MHRA
Education & Training Events
07/09/2010
21/09/2010
04/10/2010
04/10/2010
07/09/2010
21/09/2010
04/10/2010
04/10/2010
For more information about London and the various Symposia please visit our preview pages.
Webcast Update
See our latest webcast on 'New European Variations Legislation and Guidelines' filmed during the joint TOPRA-EMA meeting held in London.
Video Training
Regulatory Affairs Awards
Nominations for the Regulatory Affairs Awards are now closed!
For information on the judges and the judging process, and a countdown to the Awards ceremony go to www.regulatoryaffairsawards.org
Evaluating Medicines
TOPRA’s first book is a collaboration with the Medicines Evaluation Board of The Netherlands. Evaluating Medicines was originally published in Dutch, but has now been translated to reach a wider audience.
Order your copy now to gain an insight into the intricate nature of the EU regulatory system from an insider’s perspective.
Special Interest Networks
PharmaTimes Clinical News
- AMS medical research review to consider single regulator
- Parexel ends fiscal year with Q4 book-to-bill of 2.18
- Drug development needs to embrace “clinical/commercial convergence”
- Slow enrolment sets back completion date for Vytorin trial
- Pharmaron consolidates Chinese presence with Bridge acquisition
PharmaTimes World News
- Biogen files fampridine PR in Europe, teams up with Trillium
- US govt study probes “extraordinary” Rx price rises
- Alcon shareholders file lawsuit to stop 'brazen' Novartis takeover
- FDA panel rejects expansion of Forest drug
- New year, new inflammatory bowel disease candidate for GSK
Membership
Enjoy the benefits of being a member of TOPRA.
