Regulatory Strategy From Development To the Market Place
This masterclass module will enable you to consider and evaluate the practical regulatory aspects of regulatory strategy for commercializing products and maintaining the brand from the development stages to registration and throughout the product lifecycle and explore and critically debate the regulatory issues likely to arise prior to and during commercializing of products in order to be able to provide effective advice on such situations.
Date: 26–28 September 2018
Time: Start time (Day 1) 14:30 – End time (Day 2) 15:45
Venue: Radisson Blu Hotel, Malmö, Sweden
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 awareness 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
Who should attend
This Masterclass is suitable for students of the MSc and delegates interested in the evaluation of the regulatory strategy needed for a product from development stages through to the market place.
This masterclass module provides an opportunity to discuss and recognise the key strategic elements of which regulatory professionals need to establish with cross-functional teams such as medical affairs, commercial, market access and legal functions to be able to strategically help define a product from development stages through to the market place; protecting the brand and strategically managing the product whilst on the market.