Regulatory Strategy From Development To the Marketplace

Regulatory Strategy From Development To the Marketplace
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.


Where: TOPRA Office, 3rd Floor City Reach, 5-6 Greenwich View Place, London, E14 9NN
When: 1 - 3 December 2026
Start Day 1: 10AM-5PM BST
End Day 3: 9AM -5PM BST

This course is also available to take online

Suitable for

  • Students of the MSc programme
  • Delegates from the regulatory affairs industry who wish to develop their knowledge of the whole life-cycle of the product
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject

Course information

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 marketplace 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
  • 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


The use of case studies and workshops will assist in the achievement of these learning outcomes and enable the students to contextualise their understanding and knowledge.

Benefits to delegates

  • 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
CPD: This course provides 15 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Programme

The module programme can be downloaded here.

Module Leader

Vina Mistry








Vina Mistry
Director, Pharmistry Consulting, UK

Speakers

TOPRA Masterclasses are developed and delivered by a faculty  of expert speakers from relevant industry, agencies, notified bodies and other stakeholders and are validated by the University of Hertfordshire.


Pricing


 Standard training course registration fees
 Event Registration Type Price (GBP)
 Standard Price 
 TOPRA Member		 £1,900.00 + VAT*
 Standard Price
 Non-member		 £2,375.00 + VAT* 
 TOPRA MSc Students
  		 £1,650.00 + VAT*

Save on the full cost of membership and £180 on the price of your training
course when you add TOPRA membership to your booking (membership fees are exempt from VAT).
*VAT, where applicable, is charged at the rate of 20%.
 
 Discounted training course registration fees
 Event Registration Type Price (GBP)
 Government or academic rates
 TOPRA Member
 £1,425.00 + VAT*
 Government or academic rates 
 Non-member
 £1,781.25 + VAT*
 Charities, patient groups, full-time education rates
 TOPRA Member		 £950.00 + VAT*
  Charities, patient groups, full-time education rates
  Non-member
  £1,187.50 + VAT*

Places are also available for those in low-income countries as defined by the World Bank.
*VAT, where applicable, is charged at the rate of 20%.
 

Please email meetings@topra.org for a discount code before making your booking.

Terms and conditions

By booking a place on this course you are agreeing to the training terms and conditions.
When
01/12/2026 - 03/12/2026
Where
TOPRA Office 3rd Floor City Reach 5-6 Greenwich View Place London E14 9NN UNITED KINGDOM
Sign in or create an account to register Registration ends 30/11/2026 23:30 (GMT Standard Time)
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