When: 9 - 11 May 2023
Also available as a face-to-face course, please click here for the face-to-face registration option.
Lectures and workshops 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 and workshops will assist in the achievement of these learning outcomes and enable you to contextualise your understanding and knowledge of strategic planning.
"All lectures were extremely interesting and engaging." – 2018 attendee
Benefits to delegates
This course will enable you to:
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.
- 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.
You can view and download an example programme based on previous courses here
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. In addition to the module leaders listed above, previous speakers for this course include:
Daniela Drago - Chief Regulatory Officer, Aurion Biotech
Michael Banks - Senior Vice President, TEVA Pharmaceuticals
Ashley Burt - Senior Director, Head of Global Regulatory Operations, Seqirus
Stephan Hütter - Director Global Program Management, PharmaLex
Melanie Pires - Leading Senior Pharmaceutical Assessor, MHRA
Nicole Small - Senior Manager, Medical Technologies Specialist Team, Element Materials Technology
- 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
*VAT, if applicable, is charged at the rate of 20%
||1,700£ + VAT*
A limited number of discounted places are available at the rates below.
Please note that discounted places are not valid for those enrolled on the MSc course.
Please email us at firstname.lastname@example.org for a discount code before making your booking.
|Those working for regulatory agencies, government agencies or academic institutions
| 1,275£ + VAT*
|Those working for charities, patient groups or in full-time education
|| 1,275£ + VAT*
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions
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