Programme |
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UK Clinical Research: A Professional Awareness Update |
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Chair: Dr Virginia Acha, Associate Vice
President, Global Regulatory Policy, MSD |
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09:00 |
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REGISTRATION AND COFFEE
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09:30 |
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Welcome and Introduction
Speaker: Professor Atholl Johnston, President, Clinical & Contract Research
Association
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09:35 |
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Consultation on Legislative Proposals for
Clincial Trials
Session information.
Speaker: Dr Marc Bailey, Chief Science and Innovation Officer, MHRA
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10:05 |
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Questions & Discussion
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10:15 |
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The O'Shaughnessy Review of UK Clinical Trials
Session information.
Speaker: Emily
Hirsz, Head of Secretariat for O'Shaughnessy Review, Office for Life
Sciences
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10:45 |
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Questions & Discussion
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10:55 |
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COFFEE
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11:25 |
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HRA Response to the Review
This presentation will describe some of the ongoing work that the HRA is
leading or participating in to contribute to the Life Sciences Vision, and
reflect on the recommendations from the independent review led by Lord
O’Shaughnessy.
Speaker: Dr Janet
Messer, Director of Approvals, HRA
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11:55 |
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Questions & Discussion
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12:05 |
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MHRA Response to the Review
Session information.
Speaker: Dr Marc Bailey,
Chief Science and Innovation Officer, MHRA
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12:35 |
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Questions & Discussion
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12:45 |
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LUNCH
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13:45 |
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DHSC Response to the Review
Session Information.
Speaker: Emma Lowe, Head of Research Policy - Clinical Research & Growth,
DHSC
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14:15 |
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Questions & Discussion
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14:25 |
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Status of UK Combined Review Process
This session will provide an opportunity to reflect on how combined
review is working, particularly in comparison with experience of the new
regulatory process in the EU and using CTIS. What are the lessons and
opportunities for the UK?
Speaker: Dr Janet
Messer, Executive Director of Approvals, HRA
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14:55 |
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Questions & Discussion
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15:05 |
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TEA
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15:35 |
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Building UK Leadership in Next Generation
of Clinical Trials: RWD-enhanced Trials
This
session discusses the future of data linkage in clinical trial evidence
generation. The UK healthcare system and connected data infrastructures are
uniquely positioned to support innovative clinical trial designs. There is a
growing global demand for clinical trials that are linkable to real-world
data such as electronic health records, administrative and claims data, and
disease registries. Sponsors are realizing that clinical trials linked to
real-world data at the patient level can enhance evidence generation beyond
what is possible in traditional clinical trials and are taking steps towards
making their trials linkable to RWD. There are success stories in the UK
that can help navigate the linkage process, unleash this unique capacity at
scale, and create a competitive advantage for the UK to attract innovative
clinical trials.
Speakers:
Dr Mehdi NajafZadeh, Senior Director, Medidata AI
Ben McConnochie, Director of Strategic Development, Medidata AI
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16:05 |
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Questions & Discussion
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16:15 |
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Pivotal Advancements in Technological
Innovation Across Clinical Trials
The impact of new technology innovations has exponentially changed our
lifestyles over the past decades. Through new scientific and technological
innovations, we have seen accelerated drug, device, vaccine development
across the life sciences and healthcare sectors benefiting communities. This
session looks at some of the patient centric innovations being adopted to
digitize and in general modernize clinical trials.
The discussion will provide an overview of the
evolution of decentralized clinical trials and the regulatory positions and
considerations within the European/UK region.
The session will also include a brief
overview of other related technologies being used in clinical trials
pertaining to the 'unleashing of power of data', such as the use of
artificial intelligence, use of historical data to inform trials etc, to
deliver more accurate, timely, and insightful clinical outcomes that lead to
transformative healthcare solutions for humanity.
Speaker: Fiona Maini, Chair, New Technologies Working Group, EUCROF
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16:45 |
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Questions & Discussion
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16:55 |
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Summing up and close
Chair and Speaker: Professor Atholl Johnston, President, Clinical & Contract Research
Association
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