Module 10 | TOPRA

Optimising the Contribution of Regulatory Affairs to Product Development, Maintenance and Commercialisation

Aim

The aim of this module is to provide students with an understanding of the skills needed to run a successful Regulatory Affairs department in order to optimise the contribution that Regulatory Affairs can make to the development, maintenance and commercialisation of products.In addition, the importance of liaison and collaboration with other key departments will be addressed,together with an introduction to the influencing and negotiation skills needed for effective teamwork.

Learning outcomes

Students will be able to provide examples of policies and processes needed to run a Regulatory Affairs department.
Students will understand and be able to outline recruitment and training objectives in Regulatory Affairs.
Students will examine the tools, such as regulatory intelligence and IT, that are available to help manage a department.
Students will focus on the key departments with whom Regulatory Affairs need to work co-operatively.
Students will understand how they can maximise the contribution they can make to product development, maintenance and commercialisation by working in collaboration and negotiating appropriately with other departments.
Students will appreciate the necessity of project/portfolio management and decision analysis.

Outline of Module topics

Building a Regulatory Department
Training for a Regulatory Department
IT support
Regulatory intelligence
Collaboration with Pharmacovigilance, Marketing, Quality Control
Introduction to negotiation skills
Business planning, budgeting and registration fees
The politics of regulation (influencing and lobbying)
Product development plans and Regulatory project planning
Decision analysis and portfolio management

Links with other modules

Module 1 complements this module, covering aspects of project management, development strategies, regulatory procedures and the commercial implications of drug development.