Regulatory Requirements for a New Active Substance: Quality

Regulatory Requirements for a New Active Substance: Quality
This Masterclass is also Module 3 of the TOPRA MSc Regulatory Affairs and will help you understand and provide advice on quality data requirements in the pharmaceutical regulatory environment as well as address practical regulatory questions in this area.

: 2 - 4 February 2022
Where: Online
Start Day 1: 13:00 GMT End Day 3: 16:00 GMT

Also available as a face to face course, please click here for the face to face registration option

Course overview

This Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of chemistry and pharmacy data. It will cover the regulatory requirements imposed on preparing chemistry and pharmacy data, as well as the processes of preparing chemistry and pharmacy documentation such as the Common Technical Document, IMPDs and INDs.

Lectures and workshops will cover the following:

  • Understanding the application of modern approaches for preparing the chemistry and pharmacy development programme
  • The latest requirements for the role of chemistry and pharmacy in the overall drug development programme
  • The chemistry and pharmacy dossier format and structure in the EU and US
  • Analytical methods and validation 
  • Manufacture of the drug products
  • Quality control of specifications for the drug substance and drug product

The use of case studies and workshops will assist in the achievement of these learning outcomes and enable you to contextualise your understanding and knowledge.

Benefits to delegates

This course will enable you to:

  • Display a systematic understanding of, knowledge of, and a critical awareness of the Chemistry and Pharmacy data requirements and interpretation during development of a new chemical active substance
  • Gain a comprehensive understanding of good manufacturing processes in formulation and the validation requirements in the context of drug development
  • Demonstrate conceptual understanding of the legal and regulatory requirements for the development of a new active substance including EU clinical directives, global legislation and guidelines to evaluate current research critically
  • Demonstrate the ability to critically analyse the legal documentation and regulatory considerations for the chemistry and pharmacy data required for developing the specifications for the drug product
  • Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate conclusions clearly to specialist and non-specialist audiences
  • Critically appraise and evaluate communications from regulatory bodies and research publications covering chemistry and pharmacy data
CPD: This course provides 19 CPD hours upon successful completion

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


The draft agenda is available to download HERE

Module Leader

Karen Foster - Global LCM Regulatory Affairs, Procter and Gamble Technical Centre 




Suitable for

  • Students of the TOPRA MSc programme
  • Delegates from the regulatory affairs industry who wish to develop their knowledge of the requirements for a new active substance
  • Delegates from allied industries who wish  to have a comprehensive understanding of the subject

Students of the MSc and those working in regulatory affairs departments.



  • TOPRA MSc students: £1500+VAT*
  • Delegate: £1700+VAT*

Discounted places

A limited number of discounted places are available for those working for regulatory or government agencies, academic institutions, charities or patient groups, and/or those in full time education. Price: £1275+VAT*.

Please email us at for a discount code before making your booking.

*VAT, if applicable, is charged at the rate of 20%.

    Terms and conditions

    By booking a place on this course you are agreeing to the training terms and conditions.

    02/02/2022 - 04/02/2022
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