TOPRA Summit 2019

How the regulatory process works and how decisions are made is evolving. Two of the most significant factors influencing this are the drive for patient-centred regulation and the expansion in innovative sources of regulatory data.



The Future of Regulatory Decision-Making

When: 23 May 2019
Where: One Moorgate Place, London, EC2R 6EA
Time: 1pm-7pm

TOPRA has held an Annual Summit in each of the last three years as part of its commitment to advancing regulatory thinking and giving senior regulatory professionals the opportunity to debate the future of the profession and make suggestions on how processes and people might develop to improve the delivery of medicinal products to market. Each Summit has resulted in a report, which we make available to the profession and interested stakeholders and which can be viewed at the Papers section of our website.

Programme

How the regulatory process works and how decisions are made is evolving. Two of the most significant factors influencing this are the drive for patient-centred regulation and the expansion in innovative sources of regulatory data.  Consequently, senior regulatory professionals must prepare themselves and their teams for a radical new regulatory landscape, in which their roles may alter, requiring new personal competencies and management structures. 

The TOPRA Summit 2019 will explore the current facts and future developments in these two areas and give an opportunity to shape the thinking on how regulatory must respond. 

INFORMATION Sessions

Challenging presentations from experts will help set the scene and inform the attendees:

Innovation in Regulation – Preparing for novel data and approaches that will challenge Regulatory Decision Making

Medicines are becoming more personalised, data sources more diverse, we are developing novel data analytics capabilities and shortening the timeline for presentation of data to regulators utilising novel regulatory pathways. As this challenges regulatory organisations, regulators and the decision-making process: 

  • How will we prepare for new competencies and innovative strategies to present data more dynamically and ensure technological and cultural transformation of our profession.
  • How can we ensure the cultural transformation of our profession?

Speakers for this session will include:

  • Professor Steffen Thirstrup - Director, NDA Advisory Board, Denmark
 
Patient Engagement – How and Why should Leaders of Regulatory Organisations transform their team’s approach?

Patients will ultimately receive our medicines and play an increasing role in how to develop medicines and sharing their view on the benefit v risk. But:

  • What stages should regulatory organisations be engaging with patients and on what issues?
  • How will this ensure we develop better medicines and increase the value of the insights shared. Does your group have the appropriate processes, capabilities, strategies across the lifecycle? 

Speakers for this session will include:

  • Matthew May - Programme Coordinator, European Patients’ Academy on Therapeutic Innovation (EUPATI), Belgium 
  • Cordula Landgraf - Head of Networking, Swissmedic (Swiss Agency for Therapeutic Products), Switzerland

IMPACT Sessions 

Workshops will allow in-depth discussions and development of proposals for presentation in the Summit whitepaper and sharing with key influencers. 
The ticket price includes a light lunch and a networking drinks reception at the close of the meeting.

CPD

This meeting offers 5 CPD hours for successful completion.  To learn about why CPD is important, visit our Lifelong Learning page.

Pricing

Meeting Price (£) (to register, please log in or create an account)

Members: 

£245 + VAT

                 

Non members: 

£295 +VAT


Terms & conditions

Please read the training terms and conditions before booking this meeting. By booking a place on this meeting you are agreeing to the training terms and conditions.

- All fees are shown in Pounds Sterling and do not include VAT 
- Fee excludes accommodation and travel. The delegate ticket includes lunch, refreshments at coffee breaks and a drinks reception.


When
23/05/2019
Where
One Moorgate Place Chartered Accountants Hall London EC2R 6EA UNITED KINGDOM
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