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 8 CPD hours upon successful completion

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


The latest course programme can be downloaded here.


All CRED courses are taught by experts with real-life practical knowledge and experience. Past presenters have included experts from MHRA, Concordia, Diamond BioPharma Ltd and Voisin Consulting Life Sciences. 


Book now at 2018 registration fees!

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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On occasions, TOPRA takes photographs and videos which may be used to help promote our conferences and courses (both online and in print). By purchasing a ticket to attend this meeting you are confirming that you are aware of this and have no objections to your image or voice appearing in any material issued by TOPRA after the meeting.

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Recording and photography by delegates is not permitted.