Regulatory Strategy for a NAS: Global Clinical Development

Regulatory Strategy for a NAS: Global Clinical Development
Regulatory Strategy for a New Active Substance: Global Clinical Development  is also Module 4 of the MSc and 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.

When:16-18 May 2022
Where: Online
Start Day 1: 15:30 CEST End Day 3: 15:45 CEST

Also available as a face to face course, please click here for the face to face registration option

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.

Programme

A copy of the draft agenda can be found HERE

Module Leaders

Nicole Herijgers - Associate Director Regulatory Affairs, EMEA Liaison, Janssen Biologics,  (Netherlands)
Liesbeth  Hof - Director Project Management Office at AM-Pharma (Netherlands)

Speakers

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:

    • Ian Braithwaite, Senior Vice President, Worldwide Clinical Trials (UK)
    • Thomas Zwingers, Senior Principal Consultant, CROS-NT (Germany)
    • Amy Cheung, AstraZeneca
    • Bob Clay, Managing Director, Highbury Regulatory Science (UK)
    • Julia Forjanic Kapproth, Trilogy Writing & Consulting (Germany)
    • Lambert Creuwels, Medical Safety Advisor, Lundbeck (Netherlands)
    • Michelle Ortis, Director, Regulatory Affairs, Oncology & Anti-Infective. Gilead

    • Jeroen Aerssens, Senior Scientific Director & Janssen Fellow, Head Translational Biomarkers, Janssen Infectious Diseases

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

Pricing

    Standard

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

    Discounted places

    A limited number of discounted places are available for those working for regulatory or government agencies, academic institutions, charities or patient groups, and/or those in full time education. Price: £1275+VAT*.

    Please email us at meetings@topra.org for a discount code before making your booking.

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

    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.
    When
    16/05/2022 15:30 - 18/05/2022 15:45
    Where
    ONLINE
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