WHEN: 3 July 2018
WHERE: Devonport House, London
TOPRA has held an Annual Summit in each of the last two 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 white paper, which we make available to the profession and interested stakeholders and which can be viewed at the Papers section of our website.
The Regulatory Profession in a disrupted Health Care System – how to remain fit for purpose
We plan to debate the effect of advancements in distributed digital technologies and enablers, and how these possibilities can best be harnessed and used in regulatory decision making – both for safety monitoring and as the evidence base for approvals or label expansions. We also want to explore the challenges progressions in areas like cell therapy, tissue engineering, 3-D printing and multi-pronged biotech products put on the current regulatory framework. Finally, we want to challenge ourselves to think whether the regulatory profession – whether in an industry setting or in a regulatory agency environment – is sufficiently well educated and prepared.
The Summit will comprise scene-setting by several key opinion leaders giving their reflections on this topic from their own perspective. This will be followed by break-out discussion groups to give participants an opportunity to develop ideas for how regulatory professionals can develop their skills to support the different stakeholders to meet these challenges. Meeting attendees will also be invited to develop a view on how to incorporate new science and technologies into future legislation or guidance. The Meeting Proceedings and feedback from the discussion sessions will once again be published as a white paper to help guide the regulatory profession moving forward.
Download the programme here.
This meeting offers 5 CPD hours for successful completion. To learn about why CPD is important, visit our Lifelong Learning page.
Meeting Price (£) (to register, please log in or create an account):
||Meeting and Dinner:
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- Fee excludes accommodation and travel. The delegate ticket includes refreshments at coffee breaks and dinner (if applicable).