When: 23 April 2020 (live session online); on-demand presentations available for download from 23 March
Where: Online
Time: Live session will take place from 09:30 to 12:30 BST (GMT +1) on 23 April.
Course overview
This course will cover:
- An introduction and overview of the pharmaceutical GMO environment including the use of GMOs in clinical trials
- Common pitfalls of GMO submissions from an industry perspective
- Risk assessments for clinical trials involving GMOs
- Beyond Europe: feedback from Canada - what you need to know about GMO submissions in Canada
- Live question and answer session with the speakers
- Case study on the strategic considerations for clinical trial and GMO submissions
Benefits to delegates
- Understand the key issues in biotechnology/biopharmaceuticals and successfully navigate the GMO legislative framework in Europe
- Be able to advise on GMO submissions within your company or team
- Gain an appreciation of the requirements for a biotechnology IMPD and be able to complete Regulatory GMO application forms
- Learn from experts in the field
- Learn by doing - participate in case studies
- Develop skills to increase performance and support career progression
CPD: This course provides 8 CPD hours upon successful completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
Download a copy of the programme here.
Presenters
Confirmed:
 Jayne Hunt
Associate Director, Regulatory Affairs
Boyd Consultants, UK |
 Sabine Rühle
Senior Associate, Regulatory Affairs
Boyd Consultants, UK |
Janneke Westra-de Vlieger
Associate Director, Regulatory Affairs
Janssen Vaccines & Prevention B.V., the Netherlands |
 Myra Widjojoatmodjo
Director, Global Regulatory Affairs
Janssen Vaccines & Prevention B.V., the Netherlands |
Additional working party members:
- Carol McConnell, Regulatory Director, Orchard Therapeutics, UK
- Kathryn Parsley, Associate Director, Regulatory Affairs, Boyd Consultants, UK
- Pierre Omnes, Executive Director, Site Start-up & Regulatory, Syneos Health, France
- Sean Russell, Director, Regulatory Affairs, Achilles Therapeutics Ltd, UK
Pricing
| Type |
Member |
Non-member |
| Standard |
£550 + VAT |
£675 + VAT |
Discounted places
A limited number of discounted places are available at the rates below. Please email us at meetings@topra.org for a discount code before making your booking.
|
|
Those working for regulatory agencies, government agencies or academic institutions
|
£412.50 + VAT
|
£506.25 + VAT |
| |
|
|
Those working for charities, patient groups or in full-time education
|
£275 + VAT |
£337.50 + VAT |
*VAT, if applicable, is charged at the rate of 20%
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions
Registration
Simply log in or create an account and then register using the 'Register Myself' button that will appear below when you are logged in.