Regulatory Strategy for a New Active Substance: Nonclinical

Regulatory Strategy for a New Active Substance: Nonclinical
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. This is also Module 2 of the TOPRA MSc Regulatory Affairs.

When: 3 - 5 July 2019
Where: De Vere Latimer Estate, Chesham, UK
Start Day 1: 15:00 | End Day 3: 16:00

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 imposed on drug development
  • The process of preparing documentation for the nonclinical dossier including considerations for the non-clinical dossier study reports and summaries
  • Modern approaches to nonclinical regulatory requirements for carrying out drug development including the latest requirements for toxicology, genotoxicity, carcinogenicity and reproduction testing
  • The role of regulatory affairs throughout the nonclinical phase to filing and life-cycle management
  • Preparation of the nonclinical components of regulatory submissions including 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 contextualise their understanding and knowledge. 

Benefits to delegates

This course will enable you to:

  • Develop a systematic understanding of , and a critical awareness of the practical management aspects of nonclinical development, types and design of nonclinical safety and pharmacokinetic requirements in the context of the nonclinical research phase of 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 completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.


The latest course programme can be downloaded HERE


Module Leaders

Lesley Reeve, Director, Nonclincal Regulatory Strategy, Covance


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

Suitable for

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


    Course fees:
    Type Student Delegate
    Standard    £1500+VAT £1700+VAT 

    Discounted places
    A limited number of discounted places are available  for those working for regulatory or government agencies, academic institutions, charities, patient groups or full time education 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 
    Those working for charities, patient groups or in full-time education

    • VAT, if applicable, is charged at 21% 
    • The registration fee does not include accommodation 
    • Refreshments, lunch and evening meal are included in the registration fee

    Related courses

    Module 8: Data for Abridged Applications and Specialised Products
    Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products


    Next steps

    Module 3: Regulatory Requirements for  a New Active Substance: Quality

    Book now

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    Terms and conditions

    Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions
    03/07/2019 - 05/07/2019
    De Vere Latimer Estate Chesham HP5 1UG UNITED KINGDOM
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