TOPRA is committed to continuing to support the education of regulatory professionals in this unprecedented situation. However, in light of recent developments and the advice from health authorities, we have made the decision for this course to go ahead as an interactive online course on the same date with many opportunities for questions to the speakers. All delegates already booked on the course will be individually contacted and if you require further information please email meetings@topra.org.
Where: Online
When: 1-3 July 2020
Day 1: 14:30–19:00 BST (GMT+1) | Day 2: 08:30–17:00 BST (GMT+1) | Day 3: 08:30–16:00 BST (GMT+1)
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
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 latest course programme is available 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. The speakers for this course include:
Tannyth Cox
Manager
Prescription Medicines Code of Practice Authority (PMCPA)
Helen Erwood
Director, Global Regulatory Affairs
ESPL Regulatory Consulting
Daniel Jackson
Global Head of Market Access Policy
UCB Biopharma
David Knight
Partner
FieldFisher
David Lewis
EU QPPV Head
Novartis Pharma GmbH
Amanda Roche
Associated Director, Regulatory Development - China
Biogen Idec Ltd
Lynda Scammell
Senior Enforcement Advisor
MHRA
Anne Vinther Morant
Independent Regulatory Science Consultant
Anne Morant Consulting
Janet Worrell
Head of Regulatory
JensonR+ Limited
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
Course fees:
| Type |
Student |
Delegate |
| Standard |
£1500+VAT |
£1700+VAT |
Discounted places
A limited number of discounted places are available for those working for regulatory or government agencies, academic institutions, charities, patient groups or full time education at £1275+VAT
Please email us at meetings@topra.org for a discount code before making your booking.
Please note that discounted places are not valid for those enrolled on the MSc course and cannot be used in conjunction with any other offer.
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- VAT, if applicable, is charged at 20%
- The registration fee does not include accommodation
- Refreshments, lunch and evening meal are included in the registration fee
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Related Course
Module 1: Strategic Planning in Regulatory Affairs
Next Steps
Module 10: Leadership and Strategic Planning in Regulatory Affairs
Module 12: Data Management and Digitalisation in Regulatory Affairs
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions