Regulatory Strategy for Established Active Substances

Regulatory Strategy for Established Active Substances
This Masterclass is also Module 7 of the MSc and is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of and the strategic issues to be considered in relation to medicines containing established active substances, including line extensions, generics and the relevant aspects for OTC products. It will allow them to examine the regulatory requirements imposed on these substances.
When: 12 - 14 October 2022
Where: TOPRA Office, 3 Harbour Exchange, London, UK
Start time Day 1: 13:00 GMT | End time Day 3: 16:30 GMT

 

Course overview

This masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation of the strategic issues to be considered in relation to medicines containing established active substances, including line extensions, generics and the relevant aspects for OTC products. It will also examine the regulatory requirements imposed on established active substances.

Benefits to delegates

  • Display systematic understanding of knowledge and a critical awareness of the strategies for approval of established active substances in the context of abridged applications and OTC products
  • Have a critical understanding of the regulatory requirements, directives and associated documentation associated with established active sustance approval
  • Demonstrate a conceptual understanding of the legal requirements for approval of established medicinal products as OTC products that enables the student to evaluate critically current research and advanced scholarship in the discipline
  • Demonstrate the ability to analyse critically the legal documentation and regulatory considerations of established active substances
  • Deal with complex issues both systematically and creatively, make sound judgement in the absence of complete data and communicate their conclusions clearly to specialist and non-specialist audiences regarding established active substances
  • Critically appraise and evaluate communications form regulatory bodies and research publications regarding established active substances.
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 downloaded HERE

Module Leaders

 Orlaith Ryan Orlaith Ryan
Founder
Shorla Pharma, Ireland 
 Eva Kopecna Eva Kopecna
Head of Global Regulatory, Pharmacovigilance and Medical Affairs
ACINO, Switzerland

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.

This course is suitable for

  • Students of the TOPRA MSc programme
  • Delegates from the regulatory affairs industry who wish to develop their knowledge of the requirements for established active substances
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject

 

Pricing  

    Course fees:

    Type
    Standard
     Student
    £1500+VAT
     Delegate
    £1700+VAT

    • VAT, if applicable, is charged at 20% 
    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 meetings@topra.org 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.

       


    Terms & conditions

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

    When
    12/10/2022 - 14/10/2022
    Where
    London UNITED KINGDOM
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