Westminster Health Forum

We are continuing to organise full-scale virtual conferences which retain all the features of physical seminars, including full programmes, presentations with slides, panel discussions and live delegate questions and comments sessions, person-to-person and group networking, and a permanent record provided to all delegates afterwards. New events are coming on to our conference programme all the time, so there are plenty of opportunities to join us if you haven’t already, from wherever you are.
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The future for UK regulation of medicines, medical devices and clinical trials - transparency and public trust, safety and enforcement, and support for innovation

August 2020

Price: £95 PLUS VAT

***Full-scale policy conference taking place online***

This conference will be a timely opportunity to discuss the future regulation of medicines, clinical trials and medical devices in the UK.

The agenda:

  • Priorities for regulation and the role of the MHRA
  • Meeting the challenge of regulating and developing medicines during the COVID-19 pandemic
  • Transforming care: industry view on seizing opportunities to support access to innovation
  • Stakeholder priorities for medicine regulation - safety, research integrity and innovation:
    • developing a regulatory ecosystem that supports innovation, provides regulatory certainty, and is transparent
    • Research transparency, public involvement and proportionality
    • key issues for patient care - research, communication and access to treatment
    • developing methods and technologies to ensure safe and effective medicines
    • prioritising support for the uptake and adoption of innovations
  • The future for collaboration with the EU, and the UK’s relationship with the EMA
  • Using technology to tackle irresponsible medical ads - partnership with online platforms and statutory enforcement partners
  • Key issues for ensuring quality in clinical trials and the medicine approval process - research integrity, public trust and workforce development

Developments that are relevant to the discussion:

  • Publication of the Independent Medicines and Medical Devices Safety Review’s report First Do No Harm which makes wide-ranging recommendations, including:
    • appointment of an independent Patient Safety Commissioner
    • establishment of a Redress Agency to support those who have been harmed by medicines and medical devices
    • strengthening the MHRA’s engagement with and focus on patients
    • overhauling medical device regulation and adverse event reporting, and the establishment of a central medical device database
    • expansion of the General Medical Council register to include a list of financial interests for all doctors
  • MHRA guidance for industry on regulatory flexibility during the COVID-19 pandemic, in the areas of the management of clinical trials, marketing authorisations, pharmacovigilance, inspections and good practice, blood components for transfusions, and medical devices
  • MHRA’s support for the use of remdesivir as the first medicine to treat COVID-19 in the UK under the Early Access to Medicines Scheme for medicines that are not yet licensed but when there is a clear, unmet medical need, and as UK trials demonstrate the success of using dexamethasone to treat COVID-19 patients

Areas for discussion at this conference:

First Do No Harm

  • Implications for policy, regulation and stakeholders of recommendations in the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege

The Medicines and Medical Devices Bill - and its provisions for:

  • ensuring the safety of human medicines and devices,
  • access to and availability of human medicines and medical devices, and
  • making the UK an attractive place in which to conduct clinical trials, supply human medicines or develop and supply devices.

Healthcare regulation

  • the future landscape, and role of the UK in European regulatory procedures - including key issues for maintaining access, innovation and the supply of medicines to the UK;

Clinical trials - looking at priorities for the research transparency group, and key issues including:

  • priorities for research and funding in a changing landscape and responding to urgent need during the COVID-19 pandemic,
  • what is needed from regulation to ensure the transparency of clinical trials - and how improvements in transparency will be measured,
  • maintaining the trust of the public and clinicians, and encouraging engagement, and
  • driving adoption and preventing variation.

Safety of medicines and technologies - key issues for improvement, looking at:

  • priorities for developing safe and effective treatments, and
  • awareness raising and training in the administration of treatments for staff, patients and the general public and the developing role of patient safety specialists.

Enforcement and sanctions - how non-compliance with regulations should be tackled, including:

  • proposals in the Medicine and Medical Devices Bill for enforcement notices with criminal sanctions for breaches,
  • how individuals affected by breaches to legislation will be able to bring civil proceedings forward, and
  • what more can be done to deter the manufacture and supply of counterfeit products in the future.

Innovation - ensuring the regulatory framework fosters development of new medicines and technology, including:

  • priorities for meeting ambitions around scalability and adoption of new products and devices from successful clinical trials to rollout,
  • progress of the Accelerated Access Collaborative (AAC) - set up to speed up the uptake of pioneering treatments,
  • factors for effective adoption, looking at clinician trust, the role of AHSNs and limiting variation,
  • improving the speed of the regulatory approval process, and
  • further support could be provided to innovators, with the NHS Long Term Plan emphasising the importance of innovation and bringing the benefits to patients.

Policy officials attending:

Our forums are known for attracting strong interest from policymakers and stakeholders.

It’s certainly the case with this one. Places have been reserved by parliamentary pass-holders from the House of Commons Library and the APPG on Population, Development and Reproductive Health, and officials from the MHRA; DHSC; BEIS; HM Treasury; the Department for International Trade; the Department for Trade and Investment; the Government Legal Department; HM Revenue & Customs and The Scottish Government.

This is a full-scale conference taking place online***

  • full, four-hour programme including comfort breaks - you’ll also get a full recording 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

This pack includes

  • Dropbox video recording of the conference
  • PDF transcript of the discussion, including all speaker remarks and Q&A
  • PDFs of speakers' slide material (subject to permission)
  • PDFs of the delegate pack, including speaker biographies and attendee list
  • PDFs of delegate articles