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 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
• 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

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

Programme

A copy of the draft agenda can be downloaded HERE

Module Leader

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.

This course is 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

Pricing