CRED Bioequivalence and Biowaivers Practical Workshop

CRED Bioequivalence and Biowaivers Practical Workshop
A practical workshop on bioequivalence and biowaivers focused on dosage form design. This course bridges the gaps between the guidelines and the practicalities as well as the clinical aspects of bioequivalence and the quality/pharmacy aspects of dissolution.

When: 19 April 2018 
Where: TOPRA, 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE, United Kingdom 




What is it?
This highly interactive course bridges the gaps between the guidelines and the practicalities as well as the clinical aspects of bioequivalence and the quality/pharmacy aspects of dissolution. The course will be delivered by Muhaned Al-Hindawi, a technical expert and former MHRA assessor. There will be lots of opportunities to ask questions.           

Who is it for?
This course is designed for regulatory, pharmacy and clinical technical experts working on generic products.


What will I learn?
Click here to view the course programme.

This course will cover: 
  • Dosage form design & regulatory affair Strategy
  • Applicability of dissolution method linked with in vivo performance
  • Multiple strengths and if biowaiver can be applied
  • BCS based biowaiver

CPD: 7 


Speaker: Dr Muhaned Al-Hindawi
Dr Muhaned Al-Hindawi is a UK registered pharmacist with a Ph.D. degree in Pharmaceutics from the University of Wales, UK. He has more than 22 years experience in the pharmaceutical industry, followed by more than 10 years of work as a senior pharmaceutical assessor in the licensing division of the MHRA, the UK competent authority, with a credible record on both sides.


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 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 are in full-time education
  £275+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
19/04/2018
Where
TOPRA 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
Online registration not available.
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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

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