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Regulatory Strategy from Development to the Market Place

Regulatory Strategy from Development to the Market Place
Module 6 of the MSc: This masterclass module 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 and 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.

: 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



Please click here to download the programme for this course.



Module Leader and Speakers

Vina Mistry
Pharmistry Consulting Ltd 
Dr Laura Brown

Morrell David
Lewis David Consultancy 

Helen Erwood
ESPL Regulatory Consulting
Emma Fulton
Hogan Lovells

Dr Daniel Jackson 
UBC Biopharma

Amanda Roche
Biogen Idec

Paul Woods
Paul Woods Compliance

Janet Worrell
Consult2Deliver / OTC Experts


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


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.


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.



This course provides 19 CPD hours for successful completion. To learn about why CPD is important, visit our Lifelong Learning page


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).

26/09/2018 - 28/09/2018
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