Regulatory Strategy for a New Active Substance Non-clinical

Regulatory Strategy for a New Active Substance Non-clinical
This Masterclass will give delegates an understanding of the practical and legislative requirements for the non-clinical 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  Masterclass is also Module 2 of the MSc.


When
: 11-13 February 2025

Where
: Lincoln Plaza Hotel, 2 Lincoln Plaza, London E14 9BN UK
Day 1 start time: 13:30 GMT| Day 3 end time: 16:30 GMT

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 non-clinical development for a new active substance including:

  • The non-clinical regulatory requirements for drug development
  • Modern approaches to non-clinical 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 non-clinical phase to filing and life-cycle management
  • Considerations for the non-clinical 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 non-clinical development, the types and design of non-clinical safety and pharmacokinetic studies and the regulatory requirements non-clinical drug development
  • Demonstrate a comprehensive understanding of the non-clinical regulatory requirements, non-clinical guidelines and other requirements for running non-clinical drug safety studies
  • Have a conceptual understanding of the legal and ethical regulatory aspects of non-clinical 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 non-clinical regulatory documentation and guidelines for the non-clinical 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 non-clinical data
CPD: This course provides 13.5 CPD hours upon successful completionTo learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Programme

The programme is available to download HERE

 
Lesley Reeve FTOPRA,  Senior Director, Global Regulatory Strategy, Product Development and  Market Access Consulting, Fortrea

Presenters


 Paul Baldrick, Fortrea

Julianne Berrie, MHRA
   
  
Sarah Bull, Director, Tara Consulting
 
 Andy Gibbs MTOPRA, Director of Drug Development & Regulatory Strategy, LabCorp
   
 
Andrea Greiter-Wilke, Senior Principal Scientist Safety Pharmacology, Roche
 
 Tom HammondDiscovery Safety Specialist, AstraZeneca 
   
 
 Peter Kilford, Associate Vice President Business Development, Simulations Plus
  
Elisa Passini, Programme Manager in Drug Development, NC3Rs
   
 
 Michaela Sharpe, Senior Non-Clinical Director, Moare Solutions
  
Jane Stewart
, Toxicologist, Apconix
   

Suitable for

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

Pricing

Type
TOPRA MSc Student: £1650 plus VAT*
TOPRA Member: £1900 plus VAT*
Non Member: £2100 plus VAT*

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

Discounted place

  • Those working for regulatory agencies, government agencies or academic institutions receive a 25% discount.
  • Those working for charities, patient groups or in full-time education recieve a 50% discount.
  •  

A limited number of discounted places are available at the rates below. Please note that discounted places are not valid for those enrolled on the MSc course.
Please email us at meetings@topra.org for a discount code before making your booking.

Terms and conditions

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

When
11/02/2025 - 13/02/2025
Where
Lincoln Plaza Hotel 2 Lincoln Plaza London E14 9BN UNITED KINGDOM
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