CRED Generics: Understanding the Regulatory Considerations

CRED Generics: Understanding the Regulatory Considerations
Generic medicines are becoming increasingly important in the current healthcare environment and delivering these medicines to market as quickly as possible is critical.
When: 11 October 2017  
Where: TOPRA, 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE, United Kingdom  




What is it? 
This is an intensive one-day course which will equip you with the knowledge and skills needed to:
  • Advise project teams on optimal regulatory strategies
  • Understand the legislation relating to Abridged Applications
  • Have an appreciation of the legal considerations involved with data protection
  • Understand the specific regulatory considerations for the dossier, including the important Module 3 (CMC)
  • Understand the specific regulatory considerations for bioequivalence studies
  • Gain an insight into the regulator's perspective.

What will I learn?
Click here to view a copy of the programme, which includes each sessions learning objectives.

CPD: 6

How do I apply? 
Simply login or create an account and register below. 

Course fees:
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 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 are in full-time education
  £275.00+VAT
  £337.50+VAT

 

Terms and conditions 
Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.
When
11/10/2017
Where
TOPRA 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
Online registration not available.
My registration status: Not registered
Your company name
Your VAT country
Your VAT number
NOTE
Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

Register now