March 2021
Starting from:
£99 + VAT
Format: DOWNLOADABLE PDF
***Full-scale policy conference taking place online***
This conference focuses on the way forward for developing medicine regulation in the UK following the end of the transition period.
The conference will also be an opportunity to consider the impact of proposed reforms in the Government’s Integration and Innovation white paper on the future of health and care, which aims to take forward advances made through the pandemic, looking at ways of:
- improving patient access to innovative medicines and technologies
- addressing unnecessary bureaucracy
- improving the use of data and medicine registries
- taking forward more collaborative and integrated approaches to enable efficiencies
Overall, areas for discussion include:
- priorities for the MHRA in light of its evolving role following Brexit
- opportunities for regulatory collaboration with other agencies
- supporting innovation and patient access to new treatments
- the regulatory environment in the wake of the pandemic, and what can be learned from the flexible processes adapted as a result of COVID-19
The discussion is bringing together stakeholders with key policy officials who are due to attend from the MHRA, DHSC, DIT and The Scottish Government.
The agenda
- Regulatory developments and the evolving role of the MHRA
- Stakeholder priorities for the future of medicine regulation - supporting innovation, providing transparency, and ensuring patient access to medicines not affected by regulatory change
- Regulatory collaboration in the WHO EURO region - opportunities for the UK
- Working with regulatory partners and keeping the UK at the forefront of medicine regulation
- Learning from the COVID-19 response - enabling rapid regulatory response and ensuring safety
- Navigating changes to the research landscape, and supporting safety and transparency
- Clinical trials after COVID-19: maintaining speed, enhancing quality
Key areas for discussion:
- the evolving regulatory framework post-Brexit - with the MHRA now the UK’s standalone medicines and medical devices regulator:
- priorities for the MHRA as it adapts to its new expanded role
- how to provide regulatory certainty and transparency going forward
- ensuring patient access to new and innovative medicine and medical devices, including the potential impact of:
- the offer of incentives by the MHRA to encourage the development of medicines for rare diseases
- introduction of the Innovative Licensing and Access Pathway, which will provide advice for clinical trial design to ensure greater efficiency in access, with the first ‘innovation passport’ having been awarded for Belzutifan
- what more can be done to engage the UK life sciences sector in the regulatory process
- what lessons can be learnt from flexible approaches to regulation adapted in response to COVID-19, and the pace of safe vaccine approval
- the impact of the White Paper - looking at:
- taking forward innovation from the pandemic, making efficiencies, improving patient access to innovation and the use of data
- proposed changes allowing the MHRA to maintain publicly financed medicine registries to improve evidence-based decision-making
- safety - what can be learned from the Independent Medicines and Medical Devices Safety Review for improving patient safety
- collaboration and keeping the UK at the forefront of medicine regulation:
- international joint working - including the UK’s future relationship with the EU and the EMA
- research - building on UK systems already in place, partnerships with higher education institutions, navigating the evolving research landscape, and the future of funding streams
- regulation - priorities for working with regulatory partners across the UK, and internationally with other regulators going forward
- clinical trials - ensuring safety and quality, and making the UK an attractive place in which to conduct clinical trials, supply human medicines, and develop and supply devices
A scan of relevant developments:
- the Medicines and Medical Devices Act - enabling the UK to take over regulation for medicines, clinical trials and medical devices now that the UK has left the EU, as well as the bill impact assessment
- Integration and Innovation: working together to improve health and social care for all - Government White Paper on the future of health and social care, with proposals to improve safety and quality of regulation, as well as reforms to support efficiency, innovation and integration
- COVID-19 vaccines - continuing rapid approvals, with new options from a range of providers coming onstream in the UK, as well as continual monitoring of approved vaccines to ensure safety
- Innovative Licensing and Access Pathway - aimed at enhanced coordination and monitoring of product development and achieving faster patient access to innovative new medicines
- Registry of UK medical devices - to improve the performance monitoring of medical devices, and using global medical device nomenclature to align internationally
- MHRA regulatory flexibilities resulting from coronavirus (COVID-19) - guidance for industry on approaches to regulation during the COVID-19 pandemic
- First Do No Harm - the Independent Medicines and Medical Devices Safety Review - chaired by Baroness Julia Cumberlege, who has kindly agreed to part-chair this conference:
- the Review sets out recommendations to reduce the risk of avoidable harm from medicines and medical devices in the future
- MHRA response statement to IMMDS Review report publication - the Agency’s initial response, with some recommendations being implemented immediately
- the Pharmaceutical Strategy for Europe - from the European Commission, aimed at supporting the competitiveness, innovative capacity and sustainability of the EU's pharmaceutical industry
Policy officials attending:
Our forums are known for attracting strong interest from policymakers and stakeholders. Places have been reserved by parliamentary pass-holders from the House of Commons Library; the House of Lords; and the Parliamentary Office of Science and Technology, and officials from the Medicines and Healthcare Products Regulatory Agency; the Department of Health and Social Care; the Department of Health, NI; the Department for Education; the Department for International Trade; the Care Quality Commission; the Government Legal Department; the Veterinary Medicines Directorate; The Scottish Government; and the Welsh Government.
This is a full-scale conference taking place online***
- full, four-hour programme including comfort breaks - you’ll also get a full recording and transcript to refer back to
- information-rich discussion involving key policymakers and stakeholders
- conference materials provided in advance, including speaker biographies
- speakers presenting via webcam, accompanied by slides if they wish, using the Cisco WebEx professional online conference platform (easy for delegates - we’ll provide full details)
- opportunities for live delegate questions and comments with all speakers
- a recording of the addresses, all slides cleared by speakers, and further materials, is made available to all delegates afterwards as a permanent record of the proceedings
- delegates are able to add their own written comments and articles following the conference, to be distributed to all attendees and more widely
- networking too - there will be opportunities for delegates to e-meet and interact - we’ll tell you how!
Full information and guidance on how to take part will be sent to delegates before the conference
