Westminster Health Forum

Since lockdown, we have been organising our full programme of conferences online. We will continue online until further notice, to ensure we play our part in helping our employees and delegates to remain safe during this time. We are pleased that so many key stakeholders, policymakers and other interested parties - both old friends and new delegates - are taking up the opportunity to discuss public policy issues and network at our impartial seminars. New events are coming on to our conference programme all the time. So there are plenty of opportunities for you to join us if you haven’t already, from wherever you are. For booking-related queries, or information on speaking, please email us at info@forumsupport.co.uk or contact us using one of the following numbers: +44 (0)7538736244 / +44 (0)7503591880 / +44 (0)7951044809.
For delegates already booked on, we will send you the online joining instructions (including links, event numbers and passwords) five working days before your conference. If you cannot find these in your inbox please email delegate.relations@forumsupport.co.uk

The future of medicine regulation in the UK

Morning, Wednesday, 10th March 2021


***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, and in the face of the challenges currently being faced in the wake of the pandemic.


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
  • International collaboration and the UK’s future relationship with the EMA
  • 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
  • Ensuring quality in clinical trials - research integrity, public trust and workforce development

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 in rare diseases
      • introduction of the Innovative Licensing and Access Pathway which will provide advice for clinical trial design to ensure greater efficiency in access
    • 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 
  • 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 Bill - enabling the UK to take over regulation for medicines, clinical trials and medical devices after the UK leaves the EU - as well as the bill impact assessment
  • 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, 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
  • UK medicines regulator gives approval for the third UK COVID-19 vaccine - Moderna vaccine approved, following approval of both the Pfizer/ BioNTech and Oxford/Astrazeneca vaccines
  • 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, and officials from the Medicines and Healthcare Products Regulatory Agency; the Department of Health and Social Care;  the Department for International Trade; and The Scottish Government.


Overall, we expect speakers and attendees to be a senior and informed group including Members of both Houses of Parliament, and senior government officials involved in this area of public policy, together with representatives from the NHS and private health providers, executive agencies including clinical staff, regulators, pharmaceutical companies, medical technology companies, the independent and third sectors, patient groups, local authorities, research and development, law firms, consultancies, and others affected by the issues discussed as well as academics and think tanks, and others with an interest in the matters being discussed.


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



Supported by

Keynote Speakers

Jonathan Mogford

Policy Director, MHRA

Meindert Boysen

Deputy Chief Executive and Director of the Centre for Health Technology Evaluation, NICE

Professor Alastair Denniston

Research and Innovation, University Hospitals Birmingham NHSFT; Deputy Director, Birmingham Health Partners Centre for Regulatory Science and Innovation; and Member, Regulatory Horizons Council (UK)

Chairs

Daniel Zeichner MP

Vice-Chair, All-Party Parliamentary Group for Life Sciences

Baroness Julia Cumberlege

Speakers

Dr Jan Turner

Director, Safer Medicines Trust

Chris Tovey

Chief Operating Officer, GW Pharmaceuticals

Sarah Faircliffe

Legal Director, Bird and Bird

Professor Melanie Calvert

Director, Birmingham Health Partners Centre for Regulatory Science and Innovation; and NIHR Senior Investigator, University of Birmingham