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

Presenter 

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.

CPD

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

Price 

Members: £70+VAT

Non-members: £95+VAT

Access

Once you have purchased the webinar, you will receive an email from topclass@topra.org with a link to the webinar within one hour. Once received, simply click on the link in the email to access the webinar. You will have access to the webinar for six months from the day of purchase. Please note, if you select the pay later option, you will not have access until payment has been cleared.

Terms and conditions

Please read the training terms and conditions before booking this webinar. By booking this webinar, you are agreeing to the terms and conditions.

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