Module 6
Regulatory Strategy: The Market Place
Aim
The purpose of this Module is to provide students with an understanding of the strategic issues related to protecting and maintaining brand awareness throughout the product life.
Learning outcomes
- Students will recognise the needs of marketing colleagues in commercializing products and maintaining brand awareness through the development of new dosage forms, indications and switching of legal status.
- Students will demonstrate how the marketing life of a product can be optimised by use of patents and supplementary protection certificates and their role as regulatory professionals in maintaining the edge that such protection might offer.
- Students will evaluate the role of the Regulatory Affairs group in optimising the regulatory strategy in a manner which is sympathetic to the needs of pricing and reimbursement committees, such that any commercial advantages may be gained.
- Students will illustrate the importance of the SmPC as a means of communication with prescribers and as the basis for advertising and patient information.
- Students will identify the international constraints on the promotion of pharmaceutical products and OTC medicines.
- Students will define the responsibilities and requirements for keeping the licence current with respect to the reporting of adverse drug reactions.
- Students will differentiate the internal and external activities and interactions associated with issues management.
Outline of Module topics
- The Needs of the Market: what is the market place, what does marketing want from regulatory, maintaining/extending brand awareness
- Intellectual Property, patents, trademarks, product naming, copyrights, supplementary protection certificates
- Demonstrating Value: pricing and reimbursement policies, pharmacoeconomics, formularies, NICE
- Getting the Foundations Right: the importance of SmPC statements, links to advertising, patient information, public assessment reports, Freedom of Information/Transparency
- Advertising and Controls of POMs and OTCs: EU, USA, Direct to Consumer (DTC) advertising
- Life Cycle Management: data and marketing exclusivity, line extensions, new indications and dosage forms, influence of generics
- Issues Management
- OTC Switching
