August 2020
Price: £95 PLUS VAT
Format: DOWNLOADABLE PDF
***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
