Regulatory Strategy for Established Active Substances

Regulatory Strategy for Established Active Substances
This Masterclass (also Module 7 of the MSc) 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
: 23 - 25 September 2020
Where: Online
Start time Day 1: 15:00 | End time Day 3: 16:00 BST (GMT +1)

TOPRA is committed to continuing to support the education of regulatory professionals in this unprecedented situation. However, in light of recent developments and the advice from health authorities, we have made the decision for this course to go ahead as an interactive online course with many opportunities for questions to the speakers. All delegates already booked on the course will be individually contacted and if you require further information please email meetings@topra.org.

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

Download the current agenda for this course.

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. Confirmed speakers for this course include:
  • Cait Brennan - US/EU Registration Manager, Chanelle Pharmaceuticals
  • Sarah Faircliffe - Legal Director, Bird & Bird
  • Dejan Krajcar - Researcher Expert - Clinical Development, Lek Pharmaceuticals 
  • Paul Marshall - DLRC
  • James McCormick - Senior Director Business Development Solutions, Regulatory Affairs - PPD
  • Meg McCarthy - Consultant and Contract Qualified Person, PharmaqaServices Ltd
  • Andrew Modley - TEVA
  • Will Smith - Intellectual Property Associate, Bird & Bird

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.

       

    Related courses:

    Module 3 Regulatory Requirements for a New Active Substance: Quality

    Next steps

    Module 8: Data for Abridged Applications and Specialised Products

    Terms & conditions

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

    When
    23/09/2020 - 25/09/2020
    Where
    ONLINE
    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