The Regulations of Biotechnology Product
The Regulations of Biotechnology Product

Original presentation date: 22 January 2019 

Learning objectives

To understand:

  • The biotechnology products and how are they regulated
  • The characteristics of products and production processes
  • How they differ from other healthcare products
  • What are biosimilars

Target audience

  • Those who are looking for an introduction to the regulation of biotechnology products
  • New entrants to the profession, with at least 6 months of regulatory experience


Tejash Shah works as a regulatory project manager in the CMC Biopharmaceuticals department of global regulatory affairs at GSK in Ware. Tejash is a qualified Pharmacist and has a master's degree from the University of Hertfordshire, and moved into the world of Regulatory Affairs in 2015.

Tejash has a wide range of experience in Drug Discovery & Development with emphasis being on Formulation Department of monoclonal antibodies and other novel target antibody formats; such as domain antibodies and antibody fragment-conjugates.


This course offers 1 CPD hour for successful completion, to learn about why CPD is important visit the Lifelong Learning page.


Members: £70+VAT

Non-members: £95+VAT


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Terms and conditions

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