Regulatory Strategy for a New Active Substance Nonclinical

Regulatory Strategy for a New Active Substance Nonclinical
Module 2 of the MSc and Masterclass: This Masterclass will give delegates an understanding of the practical and legislative requirements for the nonclinical phase of global drug development. It will explore the regulatory issues that are likely to arise and provide advice and discussion around solutions to such situations.

15 - 17 March 2023
Where: TOPRA Office, 6th Floor, 3 Harbour Exchange, South Quay, London, UK
Day 1 start time: 13:30 GMT| Day 3 end time: 16:00 GMT

Also available as a virtual course, please click here for the virtual registration option.

Course Overview

This Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the nonclinical development for a new active substance including:

  • The nonclinical regulatory requirements for drug development
  • Modern approaches to nonclinical regulatory requirements for drug development including considerations for candidate selection and the latest requirements for pharmacokinetics and toxicology, genotoxicity, carcinogenicity and reproduction testing
  • The role of regulatory affairs throughout the nonclinical phase to filing and life-cycle management
  • Considerations for the nonclinical components of regulatory documents and submissions including IB, IMPD, IND, NDA, MAA and CTD reports

The use of case studies and workshops will assist in the achievement of these learning outcomes and enable students to consolidate their understanding and knowledge. 

This course gave a very good overview of the non-clinical development which is very helpful to further develop your understanding of this field of drug development.”  – 2018 delegate

Benefits to delegates

This course will enable you to:

  • Develop a systematic understanding,  and a critical awareness of the practical management aspects of nonclinical development, the types and design of nonclinical safety and pharmacokinetic studies and the regulatory requirements nonclinical drug development
  • Demonstrate a comprehensive understanding of the nonclinical regulatory requirements, nonclinical guidelines and other requirements for running nonclinical drug safety studies
  • Have a conceptual understanding of the legal and ethical regulatory aspects of nonclinical research and the importance of critical evaluation of the study designs and data generated during research on medicinal products
  • Demonstrate the ability to critically analyse the nonclinical regulatory documentation and guidelines for the nonclinical part of drug development
  • Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data and communicate your conclusions to the specialist and non-specialist audiences including working with other departments
  • Critically appraise and evaluate communications from regulatory bodies and research publications covering nonclinical data
CPD: This course provides 15 CPD hours upon successful completionTo learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.


You can view and download an example programme based on previous courses here

Module Leaders

  • Lesley Reeve - Director, Nonclincal Regulatory Strategy, Labcorp Drug Development
  • Andy Gibbs - Drug Development Leader, Labcorp Drug Development


TOPRA Masterclasses are developed and delivered by a faculty of expert speakers from relevant industry, agencies, notified bodies and other stakeholders, and are validated by the University of Hertfordshire. In addition to the module leaders listed above, previous speakers for this course include:

Suitable for

  • Students of the TOPRA MSc programme
  • Delegates from the regulatory affairs industry who wish to develop their strategic planning of nonclinical development
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject



    • TOPRA MSc students: 1,500£ + VAT*
    • Delegates: 1,700£ + 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: 1,275£ + VAT*
    • Those working for charities, patient groups or in full-time education: 1,275£ + VAT*

    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.

    15/03/2023 - 17/03/2023
    TOPRA Office 6th Floor 3 Harbour Exchange South Quay London E14 9EG UNITED KINGDOM
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