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.


When: 20-22 October 2021
Where: TOPRA Office, 3 Harbour Exchange, London, E14 9GE, United Kingdom
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 completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Programme

The programme is available to download HERE

Module Leaders

  • Lesley Reeve, Director, Nonclincal Regulatory Strategy, Covance

Presenters

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

Pricing  

    Standard

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

    Discounted places

    A limited number of discounted places are available at the rates below. Please email us at meetings@topra.org for a discount code before making your booking.

    • Those working for regulatory agencies, government agencies or academic institutions: £1275+VAT
    • Those working for charities, patient groups or in full-time education: £1275+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.
    When
    20/10/2021 - 22/10/2021
    Where
    TOPRA Office 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
    Sign in or create an account to register
    My registration status: Not registered
    Your company name
    Your VAT country
    Your VAT number
    NOTE
    Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

    Register now