Course description

Regulatory Strategy for Established Active Substances

This masterclass is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of the regulation ofthe 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.

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Suitability - Who should attend?

This course is suitable for

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

Outcome / Qualification etc.

Benefits to participants

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.