Course description
Regulatory Strategy From Development To the Market Place
This Masterclass is also Module 6 of the MSc regulatory Affairs, and will enable you to consider and evaluate the practical regulatory aspects of regulatory strategy for commercialising products and maintaining the brand from the development stages to registration and throughout the product lifecycle. You will explore and critically debate the regulatory issues likely to arise prior to and during commercialising of products in order to be able to provide effective advice on such situations.
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Suitability - Who should attend?
Suitable for
- Students of the MSc programme
- participants from the regulatory affairs industry who wish to develop their knowledge of the whole life-cycle of the product
- participants from allied industries who wish to have a comprehensive understanding of the subject
Outcome / Qualification etc.
Benefits to participants
- Recognition of the needs of marketing colleagues in commercialising products and maintaining brand awareness through the development of new dosage forms, indications and switching of legal status
- Ability to demonstrate how the marketing life of a product can be optimised by use of patents and supplementary protection certificates and the role of the regulatory professionals in maintaining the edge that such protections might offer
- Ability to evaluate the role of regulatory affairs in optimising the regulatory strategy in a manner sympathetic to the needs of pricing and reimbursement committees, such that any commercial advantages may be gained
- An understanding of the importance of the SmPC as a means of communication with prescribers and as the basis for advertising and patient information
- Understanding the international constraints on advertising and promotion of pharmaceuticals and OTC medicines
- Appreciation of the responsibilities and requirements for keeping the licence current with respect to risk management plans and the safety reporting of adverse drug reactions
- Differentiate the internal and external activities and interactions associated with issue management and handling falsified medicines
Training Course Content
Lectures and case studies will cover the understanding and application of modern approaches and understanding of regulatory and strategic requirements from drug development stages through to the market place including:
- Defining and shaping the brand
- Protecting the brand: Intellectual Property, patents and marketing exclusivity
- Maintaining/extending brand awraeness through line extensions
- Demonstrating value and market access through pharmacoeconomics, pricing and reimbursement policies and Health Technology Assessments
- Pharmacovigilance and risk management
- Falsified and counterfeit medical products
- Issue and crisis management
- Communicating with Patients and Prescribers and the importance of SmPC statements
- OTC switching
- Links to advertising, patient information and compliance controls: EU and USA
Expenses
The full tuition price for students is 1500 GBP. The price for participants is 1700 GBP