When: 10-12 November 2025
Where: TOPRA Office, 3rd Floor City Reach, 5-6 Greenwich View, London, E14 7NN, UK
This course is also available to attend online.
Suitable for
This course is essential for:
- Students of the TOPRA MSc programme;
- Delegates from the regulatory affairs industry who wish to develop their knowledge in leadership and management of regulatory affairs;
- Delegates from allied industries who wish to have a comprehensive understanding of the subject.
This Masterclass is also Module 10 of the MSc.
Course information
This course will cover the understanding and application of modern principles, approaches and understanding of leadership and strategic management in regulatory affairs including:
- Recruitment, training and development of regulatory affairs departments
- Regulatory affairs during mergers and acquisitions
- Competitive advantage of regulatory affairs
- Regulatory intelligence
- Collaboration with other departments such as pharmacovigilance/vigilance
- Regulatory Operations
- The politics of regulation (influencing and lobbying)
- Product development plans and regulatory project planning and decision analysis
- Product management
The use of case studies will assist in the achievement of these learning outcomes and enable you to contextualise your understanding and knowledge of strategic planning.
Benefits of delegates
This course will enable you to:
- Demonstrate a critical knowledge of how to liaise and collaborate with other departments to ensure the appropriate documentation used in development, maintenance and commercialisation of medicinal products and medical devices is in place
- Possess a comprehensive understanding of the legal requirements and management theory governing regulatory strategies to product development, maintenance and commercialisation
- Demonstrate the ability to understand the management and leadership skills required to run a regulatory affairs department as a manager, a leader or a member of the RA team
- Deal with complex issues both systematically and creatively, make sound management judgments in the absence of complete data and communicate your conclusions to the specialist audiences including working with other departments
- Appraise and evaluate communications from regulations, guidelines, research and other publications regarding the management of a regulatory affairs department.
CPD: This course provides 16 CPD hours upon successful completion.
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
You can view and download the programme here.
Module Leaders
Presenters
The expert presenters for this training course are:
- Helen Easter, Senior Director, Global Product Optimisation Programme Lead, Teva Pharmaceuticals
- Gabrielle Micallef, Senior Manager, CMC Regulatory Strategy – Biologics, Ipsen UK & Ireland
- Natasha Long, Senior Regulatory Consultant, Fusion Pharma Limited
- Sue Allen MTOPRA, Senior Director Regulatory EUCAN & Operations, Mundipharma
- Vincenzo Cannizzaro, Regulatory Affairs Expert
- John Faulkes, Principle Consultant, Phetairos Limited
- Stephen Huetter, Director Global Program Management, Pharmalex
- Eva Kopecna FTOPRA, Vice President Regulatory, Medical and Pharmacovigilance GenMed, Arcera
- Rade Injac, Senior Research Fellow, University of Ljubljana & Independent Consultant & Author
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* |
*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.
Simply log in or create an account and then register using the 'Register Myself' button that will appear below once you are logged in.