When: 26–28 September 2018
Where: Radisson Blu Hotel, Malmo, Sweden
Start time (Day 1): 14:30
End time (Day 3): 15:45
Course Overview
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
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Programme
Please click here to download the programme for this course.
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Learning outcomes
- 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
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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.
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Why attend
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.
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CPD
This course provides 19 CPD hours for successful completion. To learn about why CPD is important, visit our Lifelong Learning page.
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Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.
Course price (to register, please log in or create an account)
Students of the MSc £1500.00 plus VAT 25% (£375.00) = Total £1875.00
Delegates £1700.00 plus VAT 25% (£425.00) = Total £2125.00
Discounted rates
A limited number of discounted discounted places are available to the groups mentioned below, please email us for the code before making your booking.
Those working for regulatory agencies, government agencies or academic institutions:
Those working for charities, patient groups or in full time education:
- All fees are shown in Pounds Sterling and do not include VAT
- Fee excludes accommodation and travel. The delegate ticket includes refreshments at coffee breaks and buffet lunches (if applicable).
