Module 10
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 review examples of policies and processes needed to run a Regulatory Affairs department.
- Students will identify and apply recruitment and training objectives in Regulatory Affairs.
- Students will examine tools such as regulatory intelligence and IT that are available to help manage a department.
- Students will categorise the key departments with whom Regulatory Affairs need to work co-operatively.
- Students will establish how they can maximise the contribution they make to product development, maintenance and commercialisation by working in collaboration and negotiating appropriately with other departments.
- Students will evaluate 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.