Regulatory Strategy for a New Active Substance: GCD

Regulatory Strategy for a New Active Substance: GCD
Regulatory Strategy for a New Active Substance: Global Clinical Development (Module 4 of the MSc) This module will help you to understand and develop regulatory strategies for all aspects of global clinical research, as well as address practical regulatory issues in this area.


: 22–24 January 2020
Where: De Vere Latimer Estate, Chesham, UK
Start Day 1: 16:00 GMT  End Day 3: 16:00 GMT

Course overview

This Masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of global clinical development. It will allow them to examine the regulatory requirements imposed on clinical development, the processes of preparing documentation for clinical study reports and regulatory overview/summary documents, and strategic considerations for the running of international clinical trial programmes.

Lectures and workshops will cover the understanding and application of modern approaches and understanding of designing the clinical programme, different types of studies (pivotal studies, dose-finding, special studies) trial designs, statistical input (intention to treat, efficacy populations), pharmacoeconomics, clinical trial application strategy, special populations (paediatric, elderly, organ impairment) preclinical requirements, territories, (trial locations: diseases prevalence, patient populations, medical expertise) writing and evaluating clinical reports and summaries, risk management, and evaluating the data at the regulatory authorities, and achieving a Global Clinical Programme dossier. 

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

Benefits to delegates

This course will enable you to:

  • Possess a systematic understanding of knowledge and a critical awareness of the regulations and international directives pertaining to clinical development of a new medicine
  • Show a critical awareness of the clinical programme strategies which can be employed during development and registration of a new medicine of clinical programme strategy, and effective regulatory leadership throughout the clinical development and the registration of a new medicine
  • Display a comprehensive understanding of the EU Legislation on the different aspects of clinical development and of the procedures and regulatory requirements for clinical trial reports, clinical overview and summary documents for optimal product labelling
  • Evaluate methodologies and develop critique of the medical, statistical, economic and operational aspects of clinical trial programmes
  • Demonstrate the ability to critically analyse the legal documentation global operational clinical trial programme considerations of clinical research
  • Deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data and communicate their conclusions clearly to specialist and non-specialist audiences
  • Critically appraise and evaluate global clinical research communications from regulatory bodies and research publications
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 latest course programme is available HERE

Module Leader

Nicole Herijgers - Associate Director Regulatory Affairs, EMEA Liaison, Janssen Biologics, the Nertherlands


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. Speakers for this Masterclass include:

Suitable for

  • Students of the MSc programme
  • Delegates from the regulatory affairs industry who wish to develop their knowledge of the requirements for global clinical development
  • 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 £1275+VAT 
    Please email us at for a discount code before making your booking.
    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
    • VAT, if applicable, is charged at 20% 
    • The registration fee does not include accommodation 
    • Refreshments, lunch and evening meal are included in the registration fee

    Related courses

    Module 3 Regulatory Requirements for a New Active Substance: Quality

    Next Steps

    Module 5 Regulatory Control of Clinical Operations

    Terms and conditions

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

    22/01/2020 16:00 - 24/01/2020 16:00
    De Vere Latimer Place Chesham HP5 1UG UNITED KINGDOM
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