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Regulatory Strategy for Established Active Substances - Masterclass




Chesham, Buckinghamshire, UK


30 May 2018 - 01 Jun 2018

Reference No: T1805312-TOP

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Event Description

Course Outline:

This module 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.

Knowledge and understanding:

  • 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

Skills and attributes:

  • 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.

When & Where?

30 May 2018 - 1 June 2018

De Vere Latimer Estate


TOPRA Non-members - £1,700 plus vat
TOPRA Members - £1,500 plus vat

Travel & Accommodation is not included

Applicant Requirements
  • This course is suitable for anyone working in established active substances or individuals involved or interested in this area and students completing their MSc in regulatory affairs
Reference No: T1805312-TOP
TOPRA is the professional membership organisation for individuals working in healthcare regulatory affairs.
We work with our members internationally to enable and promote excellence across the healthcare regulatory profession.


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