When: 1 - 3 April 2025
Where: TOPRA Office, 3rd Floor City Reach, 5-6 Greenwich View Place, London, E14 9NN, UK
Start time Day 1: 13:00 BST | End time Day 3: 16:30 BST
Also available as a virtual course, please click here for the virtual registration option
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
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Orlaith Ryan
Founder
Shorla Pharma, Ireland |
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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
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
- Those working for charities, patient groups or in full-time education
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 & conditions
By booking a place on this course you are agreeing to the training terms and conditions