Module Aims

The aims of this module are to enable students to...

• Consider and appreciate strategic regulatory aspects of global regulatory affairs
• Explore and review the strategic regulatory issues in order to be able to provide effective advice on the commercial implications of regulatory affairs activities involved with approval and pricing negotiations.

Learning Outcomes

Knowledge and Understanding

Successful students will typically:

• Demonstrate a systematic understanding of knowledge, and a critical awareness of the theory and practice of global strategic planning strategies as they relate to obtaining regulatory marketing authorisation and pricing negotiations
• Display critical knowledge of the regulatory requirements, global legislation, regulatory authorisation and associated documentation for planning drug development programmes
• Demonstrate an in depth conceptual understanding of strategic plans for the regulatory approval of drug development programmes.

Skills and Attributes

Successful students will typically:

• Critically appraise and evaluate communications from regulatory bodies and research publications for the management of regulatory affairs and strategic planning in drug development
• Demonstrate the ability to critically analyse the legal documentation and regulatory considerations of drug development
• Evaluate complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences regarding planning regulatory strategies for drug development programmes for regulatory authorisation and marketing approval.