Generics: Understanding the Regulatory Considerations

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.

: 13 February 2019
Where: TOPRA. 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE
Time: 09.00 - 17.00

Course overview

This course provides delegates with a practical understanding of the particular regulatory considerations around generic products. Experts will share their knowledge and experience, providing delegates with an understanding of specific considerations for the dossier (including Module 3 CMC), and bioequivalence studies. 

Benefits to delegates

  • Meet and learn from experts in the field   
  • Learn by doing - participate in case studies and interactive sessions
  • Build a network to support the rest of your career 
  • Gain a comprehensive overview of regulatory regulations and procedures in generics medicines 
  • Discuss the impact Brexit may have on Generic medicines 
  • Take a course designed by professionals for professionals with a proven track record 
CPD: This course provides 7.50 CPD hours upon successful completion

To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

What our previous attendee said

"I learnt about what key factors to consider when faced with developing a regulatory strategy for a generic. I work for a generics based company that obtains various different dossiers and takes different approaches as to how a MA application will be applied for them, and the information provided on bioequivalence was a key area I was lacking understanding, but much information was provided by the course and I will be able to use this in future projects.” 


Downloaded the course programme here.


Eleanor Higham, Mylan 
Francesca Buttigieg, Novartis 
Jon Sisson, MHRA
Karin Bracht, MHRA  


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 at for a discount code before making your booking.

Those working for regulatory agencies, government agencies or academic institutions 
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%

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TOPRA 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
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