CRED: Regulatory Challenges of Successfully Developing ATMPs

CRED: Regulatory Challenges of Successfully Developing ATMPs
This one-day workshop is perfect for regulatory professionals with an interest in working with ATMPs and for those who already work in this area.


Attend this course if you would like to learn about ATMP development and regulation, you would like a forum to hear from experts in the ATMP field, or you are looking for an opportunity to discuss the challenges you have and share your experiences with others.

This course will cover an introduction to ATMPs, CMC and quality considerations for ATMPs, Non clinical development of ATMPs, experience in clinical development of ATMPs, Environmental risk assessments for GMOs in clinical trials, regulatory challenges and pitfalls.

 Programme includes:

  • Introduction to ATMPs
  • CMC and Quality considerations for ATMPs – Part 1
  • CMC and Quality considerations for ATMPs – Part 2 Food for Thought (examples of ATMP challenges).
  • Non clinical development of ATMPs
  • Experience in Clinical Development of ATMPs
  • Environmental Risk Assessments for GMOs in Clinical Trials
  • Regulatory Challenges and Pitfalls

Speakers include:
• Julie Foulkes, Freelance Regulatory Affairs Advisor
• Alison Wilson, Consultant Cell Data Services
• Alexis Cockcroft, Biopharm CMC Regulatory Affairs, GlaxoSmithKline
• Michaela Sharpe, Head of Non-Clinical Safety and Immunotherapy Strategy at Cell & Gene Therapy Catapult
• Kim Champion, Regulatory Manager - Advanced Therapy Trials, Cancer Research UK & UCL Cancer Trials Centre
• James W McBlane, Medicines & Healthcare Products Regulatory Agency, UK & EMA CAT member


Please view the programme for the course: programme (157 KB). 


CPD

This course offers 6 CPD hours for successful completion, to learn about why CPD is important visit the Lifelong Learning page.

To book onto this course please log in or create an account.

Course price (including VAT):

Member: £550+VAT
Non-member: £675+VAT

Those working for regulatory agencies or government agencies or academic institutions: 
Member: £412.50+VAT
Non Member: £506.25+VAT
 
Those working for charities, patient groups or in full time education:
Member: £137.50+VAT
Non Member: £168.75+VAT

For a discount please contact meetings@topra.org for the code

- Please note the number of discounted places may be limited.
- All fees are shown in Pounds Sterling and include VAT 

- Fee excludes accommodation and travel. The delegate ticket includes refreshments at coffee breaks and buffet lunches (if applicable).
- All cancellations must be received in writing 28 calendar days before the start of the course and will be subject to an administration fee of £100 + GB VAT. We regret that registrations cannot be transferred to another course, however delegate substitutions may be made up to 10 working days before the course.

 


 

 

 
When
15/06/2016
Where
CCT Venues Plus-South Quay 193 Marsh Wall South Quay London E14 9SG UNITED KINGDOM
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