What is it?

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.

Who is it for?

What will I learn?

Lectures and workshops will cover the understanding and application of modern approaches and understanding of regulatory requirements the type and range of abridged applications in Europe and the US, the legal background to abridged applications including data protection, marketing exclusivity and patent protection, options for abridged applications and use of the different regulatory procedures, strategy for abridged applications including implications for harmonisation of the SmPC, (Summary of Product Characertistics) processing of abridged applications by the regulatory authorities, particular issues for products containing well-established active ingredients,  and generic and over-the-counter (OTC) products.

The use of case studies and workshops will assist in the achievement of these learning outcomes and enable the students to put into context their understanding and knowledge. 

About the Module Leader

Phillip Thornton is a pharmacist with 25 years in pharmaceutical research and development, including pharmacology, toxicology and clinical trials. He also has 19 years' experience in regulatory affairs consultancies involved in all areas of RA with mainstream and biological products for over 40 companies.

How do I apply? 

Terms and conditions