When: 23 September 2025
Time: 09:15–17:00 GMT
Where: TOPRA 3rd Floor, City Reach. 5-6 Greenwich View Place, London, E14 9NN
Course overview
This course is split into two sections:
- Two pre-course on-demand webinars to put these skills into regulatory context
- Internal and External communication as a regulatory professional webinar
- Internal and external negotiation as a regulatory professional webinar
- A face-to-face skills workshop purely to develop these skills
The webinars will give pointers and practical insights on how to optimise the way in which you communicate with and influence stakeholders and gate-keepers. They will look at how to plan and prepare for such interactions: how to deal with possible conflict; and give suggestions on how to manage follow-up to best effect.
The workshop will enable participants to put the knowledge they learnt from the webinar into practice. They will look at how to recognise and use different negotiation strategies whilst maintaining trust and respect with complex groups of stakeholders. Develop and deliver impactful presentations and documents that deliver the results you need.
Learning Objectives
Internal and External communication as a regulatory professional webinar:
- Consideration of the key internal and external gate-keepers with whom you need to communicate.
- When and why to interact with regulators
- How to prepare for best outcomes from an internal or external interaction
- Understand the necessities of a fall-back strategy and of obtaining buy-in from internal partners
- Illustrated with the principles for holding a successful advisory meeting and how to follow up
Internal and external negotiation as a regulatory professional webinar:
- Understanding your authority – who makes the decision – how do you escalate?
- How the product life cycle stage can influence negotiation
- Dealing with conflict
- Preparation and rehearsal. Scenario mapping (what ifs?)
- The post-advice period and its follow up
Overall
- Recognise negotiation strategies and be ready to put them to use in the workplace.
- Build trust and respect whilst negotiating with complex groups of stakeholders
- Communicate complex information and data analyses to any audience
- Develop and deliver management level presentations that resonate with senior stakeholders
Benefits to delegates
- Discover the best way to communicate with different stakeholders
- Strengthen your presentation skills
- Understand the art of negotiation
- Build a network to support the rest of your career
- Learn the common pitfalls to avoid
- Take a course developed by professionals for professionals with a proven track record.
CPD: This course provides 8 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
Download a copy of the draft course programme here.
Presenters
- Joe Cheal - Imaginarium Learning & Development
Face-to-face course presenter: Joe Cheal
Joe Cheal, from Imaginarium Learning and Development, has been training, consulting and coaching since 1993, working with thousands of people from a diverse range of companies over the past 25 years. He is a highly interactive and engaging speaker who focusses on practical solutions for ‘real-world’ implementation.”
Webinar presenter: Andy Thornley
Andy was a broad-based Regulatory Affairs leader during his many years in Industry (companies included GSK and J&J) with a background for the most part in Consumer Health Regulatory Affairs, and information systems. He has been an active and enthusiastic member of multi-disciplinary process excellence, innovation and brand management teams within these companies. This enthusiasm has been carried over while representing the AESGP (self-care) industry trade association at Industry-European Medicines Agency (EMA) -EU National Competent Authority (HMA) forums for ISO IDMP/ SPOR, e-Product Information, eCTD V 4.0, EU Telematics, EU Clinical Trials Database and Portal (CTIS), and Regulatory Optimisation (ROG).
As a regular presenter/ day-chairperson for over 16 years training on behalf of TOPRA, Andy has covered both technical (EU Pharmaceuticals) and soft skills. In the webinar, Andy will draw on both areas, to present important considerations regarding communication and influencing, which should help you with your development as an effective Regulatory Affairs professional.
Suitable for
- New and experienced regulatory professionals alike.
You are no doubt talented, multi-skilled Regulatory Affairs professionals, who understand and apply your well-developed competencies, insights and knowledge acquired during your careers to-date. It is expected that your skills in written language are well honed by many hours of reviewing and commenting on regulatory documents, and by looking across regulatory submission dossiers for consistency of key messages, formatting and terminology. However this can all feel like “it’s come to nought”, if you struggle to communicate your point of view and technical know-how to the decision makers within your organisations and with external gate-keepers on the outside, including those to whom you go to for scientific advice.
Pricing
Course fees*:
| Type |
Member |
Non-member |
| Standard |
£620 +VAT |
£720 +VAT |
Include membership with your booking below to unlock members' discounts. By becoming a TOPRA member before September 30, 2023, you'll receive an additional 3 months of membership for just £20 (subject to terms and conditions). Join now to access exclusive member content and enjoy discounts on courses, including this year and next year's Annual Symposium. Please be aware that membership fees are exempt from VAT.
Discounted places
A limited number of discounted places are available at the rates below.
Please email us at meetings@topra.org for a discount code before making your booking.
|
|
Those working for regulatory agencies, government agencies or academic institutions
|
£465 +VAT
|
£540 +VAT |
Those working for charities, patient groups or in full-time education
|
£310 +VAT |
£360 +VAT |
|
*VAT, if applicable, is charged at the rate of 20%
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions