Regulatory Requirements for a New Active Substance

Regulatory Requirements for a New Active Substance
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.

:15 - 17 May 2024
Where: TOPRA Office, 6th Floor, 3 Harbour Exchange, London, E14 9GE
Start Day 1: 13:00 (BST) End Day 3: 15:00 (BST)

Also available as an online course, please click here for the online 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

Christian Maasch - Takeda


Mike James - Cambridge Regulatory Services

Jorge Colmenares - Procter & Gamble UK

Torsten Kneuss - Bayer

Fiona Routley - AstraZeneca

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: £1,545 +VAT*
    • Delegates: £1,785 +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: £1,338.75 +VAT*
    • Those working for charities, patient groups or in full-time education: £892.50 +VAT*

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

    Please note that discounted places are not valid for those enrolled on the MSc course and cannot be used in conjunction with any other offer.

      Terms and conditions

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

      15/05/2024 - 17/05/2024
      TOPRA Office 6th Floor 3 Harbour Exchange London E14 9GE UNITED KINGDOM
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