Membership

Membership and minutes for the Commission on Human Medicines (CHM) and its expert advisory groups (EAGs).

Working for us

In the public interest, ministers need the advice they receive on matters relating to the regulation of medicines and medical devices to be impartial. They also need to be able to get advice from a wide range of highly-skilled professionals who are senior and well regarded in their respective fields and from a range of appointed lay representatives.

A number of independent advisory committees have been established to provide this advice. These committees can also establish working groups to address specific problems. Members of these committees may receive a fee and can claim some expenses.

If you are interested in being part of the Commission on Human Medicines or one of its expert advisory groups you should email ECSRecruitment@mhra.gov.uk.

The Chair and Commissioners are appointed in accordance with the Code of Practice for Ministerial Appointments to Public Bodies, issued by the Commissioner for Public Appointments. The Chair and Commissioners follow a code of practice, in which they are precluded from holding personal interests. Their interests in the pharmaceutical industry are published in the Commission’s annual report each year.

The Commission meets monthly in London. The Commission is supported in its work by Expert Advisory Groups (EAGs), covering various areas of medicine. In addition, the Commission calls on experts not readily available through its membership.

Current vacancies

The CHM Expert Advisory Group is looking to appoint one expert to the Pharmacovigilance Expert Advisory Group (PEAG).

Please find attached:

The closing date for applications is midday 28 January 2022.

CHM Chair and Commissioners

(Chair) Professor Sir Munir Pirmohamed MB ChB (Hons) PhD FRCP FRCP (Edin) FBPhS, FFPM (Hon) FMedSci, David Weatherall Chair of Medicine, University of Liverpool, NHS Chair of Pharmacogenetics, Director of the Wolfson Centre for Personalised Medicine, Director of the MRC Centre for Drug Safety Science

Professor Amanda Adler MD PhD FRCP Professor of Diabetic Medicine and Health Policy, University of Oxford

Ms Susan Bradford Lay Representative

Professor Jamie Coleman MD MA (Med Ed) FRCP FBPhS Professor in Medical Education / Consultant Clinical Pharmacologist, University of Birmingham

Professor Steven Cunningham MBChB PhD FRCPCH Professor of Paediatric Respiratory Medicine, University of Edinburgh and Honorary Consultant, Royal Hospital for Children and Young People, NHS Lothian, Edinburgh

Dr Jamie Fraser BSc MB ChB MRCGP GP Partner, Southside Surgery, Inverness

Professor Jonathan S Friedland MA PhD FRCP FRCPE FRCPI FESCMID FMedSci Deputy Principal, St. George’s, University of London

Professor Richard J C Gilson MD FRCP Professor of Sexual Health & HIV Medicine, Director of the UCL Centre for Clinical Research in Infection & Sexual Health & Deputy Director of the UCL Institute for Global Health

Professor Malcolm R Macleod BSc MBChB MRCP PhD FRCP (Edin): Professor of Neurology and Translational Neurosciences, University of Edinburgh and Honorary Consultant Neurologist, NHS Forth Valley

Dr Siraj Misbah MBBS (Hons) MSc FRCP FRCPath: Consultant Clinical Immunologist, Lead for Clinical Immunology, Oxford University Hospitals

Professor Sandosh Padmanabhan MBBS MD PhD FRCP(Glasg) FRCP(Edin) FBPhS FBIHS Professor of Cardiovascular Genomics and Therapeutics, University of Glasgow

Professor Poulam Patel PhD, MBBS, FRCP Professor of Clinical Oncology, University of Nottingham

Professor Yvonne Perrie BSc Hons MRPharmS FAPS FSB PhD Chair in Drug Delivery, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow. Scotland

Professor Shirley Price MSc PhD FBTS FRSB ERT FHEA FRSC MBPharmacol Soc Visiting Professor of Toxicology, University of Surrey

Professor Marc Turner MBBS PhD MBA FRCP FRCPath FHEA Professor of Cellular Therapy; Medical Director Scottish National Blood Transfusion Service (SNBTS)

Professor Christopher Weir BSc (Hons) PhD MSc FRSS C.Stat
Personal Chair in Medical Statistics and Clinical Trials, Usher Institute, University of Edinburgh

Dr Martin Wilson MRCP (UK) MPhil (Glasgow), FRCP(Edin) Consultant Physician in Care of the Elderly, Raigmore Hospital, Inverness

Summary minutes

Summary minutes are prepared on the basis that no personal, commercial or otherwise confidential information is disclosed.

See the final summary minutes for CHM and EAGs from 2014 onwards, which you can download.

CTBV21-2 Advert - CHM Clinical Trials Biologicals and Vaccines Expert Advisory Group (PDF, 80.2 KB, 2 pages)

Previous minutes can be seen on the MHRA pages on the National Archives

Code of practice for chairmen and members of the commission on human medicines, certain committees and expert advisory groups (PDF, 103 KB, 15 pages)

CHM meeting dates

2021

Jan Feb March April May May July Aug Sept Sept/Oct Oct Dec
21/22 18/19 11/12 8/9 6/7 27/28 1/2 5/6 2/3 30/1 28/29 16/17

2022

Jan March April May June June/July Aug Sept Sept Oct Nov Dec
27/28 3/4 7/8 5/6 9/10 30/1 4/5 1/2 29/30 27/28 24/25 15/16

Infection EAG

Remit

To advise the Commission on the safety and efficacy of medicines for use in infections including HIV, AIDS and viral hepatitis.

Chair

Professor Jonathan S Friedland MA PhD FRCP FRCPE FRCPI FESCMID FMedSci Deputy Principal, St. George’s, University of London

Members

Dr Michael Brown BA BM BCh FRCP PhD DTM&H Consultant Physician, Infectious Diseases & Acute Medicine, & Clinical Director, Division of Infection, University College London Hospitals NHS Foundation Trust & Honorary Associate Professor, Clinical Research Sept, London School of Hygiene & Tropical Medicine

Dr Andrew Freedman B.A M.B,B.Chir M.A M.D FRCP FRCP Reader in Infectious Diseases, Cardiff University School of Medicine/ Hon. Consultant Physician, University Hospital of Wales

Professor Richard J C Gilson MD FRCP Professor of Sexual Health & HIV Medicine, Director of the UCL Centre for Clinical Research in Infection Sexual Health & Deputy Director of the UCL Institute for Global Health

Dr Richard Hobson MB BS MRCP (UK) FRCPath PhD LLM Consultant Microbiologist and Honorary Senior Lecturer, Harrogate & District NHS Foundation Trust/University of Leeds

Dr Susan Hopkins MB ChB BAO (Hons) BA FRCPI Consultant in Infectious Diseases and Microbiology, Royal Free Hampstead NHS Trust, Healthcare Epidemiologist, Health Protection Agency, Honorary Senior Lecturer, University College London

Dr Lim S Jones MBBCh, PhD, FRCPath Consultant Microbiologist, Public Health Wales Microbiology, Cardiff; Clinical Lead Specialist Antimicrobial Chemotherapy Unit, Cardiff; Chair of the All Wales Medical Microbiology Development & Standardisation Group

Professor Kevin Moore BSc MB BS PhD FRCP Professor of Hepatology, Royal Free Hospital, London

Dr Matthias Schmid MD FRCP DTMH Consultant Physician, Head of Department of Infection & Tropical Medicine, Director of Elective Studies Newcastle University, Royal Victoria Infirmary, Newcastle upon Tyne

Ms Hilary A Shenton CPFA Lay Representative. Retired Secretary to the School of Medicine, University of Sheffield

Professor Geraint Rhys Davies BM DTM&H PhD FRCP Professor of Infection Pharmacology, University of Liverpool, Honorary Consultant in Infectious Diseases, Liverpool University Hospitals Foundation Trust

Dr Louis Grandjean MBBS BSc MSc PhD MRCPCH Associate Professor Paediatric Infectious Diseases Great Ormond Street Hospital and University College London

Cardiovascular, Diabetes, Renal, Respiratory and Allergy EAG

Remit

To advise CHM on the safety and efficacy of medicines for used for the treatment and prevention of cardiovascular, diabetes, renal, respiratory and allergy diseases.

Chair

Professor Amanda Adler MD PhD FRCP Professor of Diabetic Medicine and Health Policy, University of Oxford

Members

Professor Patrick Mark MB CHB (Hons) PhD FRCP (Glasg) Professor of Nephrology & Honorary Consultant Nephrologist, University of Glasgow and Glasgow Renal and Transplant Unit, Queen Elizabeth University Hospital, Glasgow

Professor Theresa McDonagh BSc (Hons), MB ChB (Hons), MD (Distinction), FRCP, FESC, FHFA Consultant Cardiologist, King’s College Hospital, London & Professor of Heart Failure King’s College, London

Dr Pallav L Shah MD MBBS FRCP Consultant Physician, Royal Brompton Hospital and Chelsea & Westminster Hospital, Professor of Respiratory Medicine, Imperial College

Professor Sarah Wild MB BChir MSc PhD FRCPE FFPH, Professor of Epidemiology, Honorary Consultant in Public Health, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh

Meeting dates

2021

March May June Sept Nov
09 04 24 28 23

Chemistry, Pharmacy and Standards EAG

Remit

To advise the CHM on the quality in relation to safety and efficacy of medicinal products which are the subject of marketing authorisation applications and to advise on such other matters as are referred to it.

Chair

Professor Yvonne Perrie BSc Hons MRPharmS FAPS FSB PhD Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde.

Members

Professor Hannah Batchelor BSc PhD Professor of Pharmaceutics and Biopharmaceutics, Strathclyde Institute of Pharmaceutical and Biomedical Sciences, University of Strathclyde

Professor Barbara R Conway BSc (Pharm) PhD FRPharmS CMgr FCMI Head of Pharmacy and Professor of Pharmaceutics, University of Huddersfield, Huddersfield

Dr Majella Lane BSc PhD Senior Lecturer in Pharmaceutics, UCL School of Pharmacy

Professor Graham Buckton BPharm PhD DSc FRPharmS FRSC Emeritus Professor of Pharmaceutics, UCL School of Pharmacy

Professor Geoffrey W Hanlon BSc PhD MRPharmS Emeritus Professor of Pharmaceutical Microbiology, School of Pharmacy & Bio-Molecular Sciences, University of Brighton

Professor Christopher Marriott PhD DSc Hon DSc FRPharmS CChem FRSC FRSM (Vice Chair) Emeritus Professor of Pharmaceutics, King’s College, London

Professor Afzal R Mohammed BPharm PhD Professor of Pharmaceutics, Aston Pharmacy School, Aston University

Mrs Ruth Paulin BPharm MRPharmS Practising Community Pharmacist.

Professor Kevin M G Taylor BPharm PhD FRPharmS Chair of the British Pharmacopoeia Commission and Professor of Clinical Pharmaceutics, UCL School of Pharmacy, London

Professor Michael D Threadgill PGCE MA PhD DSc FRSC CChem Professor Emeritus in Medicinal Chemistry, Department of Pharmacy and Pharmacology, University of Bath, Visiting Professor IBERS, Aberystwyth University

Professor Darragh Murnane PhD BSc (Pharm) PhD MRPharmS Professor of Pharmaceutics and Associate Dean (Enterprise), University of Hertfordshire

Professor Susannah E Walsh PhD BSc MBA Associate Head School of Pharmacy, Professor of Pharmaceutical Microbiology, Leicester School of Pharmacy, De Montfort University, Leicester

Professor Ben Forbes BPharm PhD Professor of Pharmaceutics, Institute of Pharmaceutical Science, Kings College London

Mr Hadar Zaman MPharm, MFRPSII, IPresc, FHEA Associate Professor in Pharmacy Practice and Head of School for Pharmacy and Medical Sciences, University of Bradford, Consultant Mental Health Pharmacist at Alternative Futures Group, Associated Non-Executive Director Barnsley Hospital.

Meeting dates

2021

Jan Feb March Apr May June Aug Aug Sept Oct Nov Dec
19 16 09 06 25 29 03 31 28 26 23 14

Clinical Trials, Biologicals and Vaccines EAG

Remit

To advise the CHM on:

  • first time in human (FTIM) studies with new compounds acting (directly or indirectly) via the immune system with a novel target or a novel mechanism of action or having a secondary potential effect on the immune system via a mechanism of action which currently is not well characterised.
  • FTIM studies with novel compounds acting via a possible or likely species specific mechanism
  • Any FTIM studies which are otherwise seen as requiring expert advice
  • Other clinical trials involving classes of compound where MHRA may wish to seek external expert advice or CHM may wish to have oversight
  • Whether a product’s mechanism of action is novel and comes within the scope of the EAG
  • Pre-meeting scientific advice documentation for within scope compounds
  • Other clinical trials where MHRA may wish to seek advice or where there is a difficult risk benefit balance
  • Other clinical trials involving products where a new class safety issue has been identified
  • The quality, safety and efficacy of medicinal products of biological or biotechnological origin including vaccines which are the subject of marketing authorisation applications; and to advise on such other matters as are referred to it

Chair

Dr Siraj Misbah MBBS (Hons) MSc FRCP FRCPath, Consultant Clinical Immunologist, Lead for Clinical Immunology, Oxford University Hospitals

Members

Professor Farzin Farzaneh DPhil FRCPath FRSB, Professor of Molecular Medicine, King’s College London, Honorary Consultant in Specialist Medicine, King’s College Hospital NHS Trust

Professor Chris Goldring BSc PhD PGCert FBPhS, Professor of Pharmacology, Department of Pharmacology and Therapeutics, The University of Liverpool.

Professor Kevin Park BSc, PhD, Hon FRCP, FMedSci, FBTS, HonFBPhS Professor of Pharmacology, Department of Pharmacology, University of Liverpool

Professor Sir Andrew Pollard PhD FRCPCH Chair of the Joint Committee on Vaccination and Immunisation; Professor of Paediatric Infection and Immunity, University of Oxford

Dr Robin Thorpe PhD FRCPath Retired, Head, Division of Biotherapeutics, National Institute for Biological Standards and Control (NIBSC)

Professor Marc Turner MBBS PhD MBA FRCP FRCPath FHEA Professor of Cellular Therapy; Medical Director Scottish National Blood Transfusion Service (SNBTS)

Professor Christina Yap MSci PhD C.Stat Professor of Clinical Trial Biostatistics, Team Leader in Early Phase and Adaptive Trials Team, ICR-Clinical Trials and Statistics Unit, The Institute of Cancer Research

Meeting dates

2021

Jan Feb March Apr May May June Aug Aug Sept Oct Nov Dec
18 15 08 06 04 24 28 02 31 27 25 22 13

Gastroenterology, Rheumatology, Immunology and Dermatology EAG

Remit

To advise the CHM on the safety and efficacy of medicines for use in gastroenterological, rheumatological, immunological, and dermatological diseases.

Chair

Professor Anthony G Wilson MB BCH BAO DCH PhD FRCP Professor of Rheumatology, Medical School, University of Sheffield

Members

Professor Anjan Dhar DM, MD (Medicine), FRCPE, AGAF, Cert. Med. Ed, FHEA Professor of Medicine (Teesside University), Consultant Gastroenterologist, Clinical Lead for UGI Cancers, County Durham & Darlington NHS Foundation Trust

Dr Shahida Din BMSc, MBChB, PhD, FRCP (Edin) Consultant Gastroenterologist & NHS Research Scotland Clinician, NHS Lothian; Honorary Senior Clinical Lecturer, University of Edinburgh.

Dr Michael Ardern-Jones BSc MBBS DPhil FRCP Associate Professor, University of Southampton and Consultant Dermatologist

Mr David Chandler Lay Representative. Chief Executive, Psoriasis and Psoriatic Arthritis Alliance, Hertfordshire

Professor Kevin Moore BSc MB BS PhD FRCP Professor of Hepatology, Royal Free Hospital, London

Professor Celia Moss OBE BA(Hons) MB BS MA MRCP DM FRCP MRCPCH Consultant Dermatologist, Birmingham Women’s and Children’s NHS FT, Honorary Professor of Paediatric Dermatology, University of Birmingham

Professor Nidhi Sofat PhD MBBS FRCP PGCert FHEA Professor of Rheumatology, St Georges University London

Dr Ravishankar Sargur MD, FRCPath, FRCP, MBA Consultant Clinical Immunologist and Clinical Lead for Laboratory Immunology, Northern General Hospital, Sheffield

Meeting dates

March May July Sept Dec
05 21 30 24 10

Medicines for Women’s Health EAG

Remit

To advise the CHM on the safety and efficacy of medicines related to endocrinology and women’s reproductive health from menarche to menopause and conditions related to the menopause, such as osteoporosis. The medicines covered will include medicines for contraception, emergency contraception and termination of pregnancy; medicines for infertility and assisted conception; hormone replacement therapy (HRT) and non-hormonal treatments for osteoporosis.

Chair

Professor Philip Hannaford, FRSE Emeritus Professor of Primary Care, University of Aberdeen

Members

Dr Amparo Alvarez-Llobell GP at Higherland Surgery GPwSI in Women’s Health Speciality Dr in GUM

Dr Caitlin Dean RGN, MSc, PhD Chair Trustee, Pregnancy Sickness Support

Dr Kenneth Hodson MD MBChB MRCP(UK) MRCOG Head of UK Teratology Information Service UK Teratology Information Service Ms Linda Pepper BA MA (Education) Independent Consultant: patient and public involvement in healthcare

Professor Stuart Ralston MB ChB MD FRCP FMedSci FRSE FFPM (Hon) Professor of Rheumatology, University of Edinburgh, Western General Hospital, Edinburgh

Mr Ertan Saridogan PhD MRCOG Consultant in Gynaecology, Reproductive Medicine and Minimal Access Surgery, University College London Hospitals (UCLH) Elizabeth Garrett Anderson Wing

Dr Laurie Tomlinson MBBS MSc PhD Department of Non-communicable Disease Epidemiology Faculty of Epidemiology and Population Health London School of Hygiene & Tropical Medicine

Dr Diana Wellesley FRCP (Vice Chair) Head of Prenatal Genetics, Consultant and Honorary Senior Lecturer in Clinical Genetics, Wessex Clinical Genetics Service, Princess

Meeting dates

Jan Feb March
18 15 29

Neurology, Pain and Psychiatry EAG

Remit

To advise the CHM on the safety and efficacy of medicines for use in neurological conditions, pain management and psychiatric conditions.

Chair

Professor Malcolm R Macleod BSc MBChB MRCP PhD FRCP (Edin) Professor of Neurology and Translational Neurosciences, University of Edinburgh and Honorary Consultant Neurologist, NHS Forth Valley

Members

Dr Lisa Brownell BSc(Hons) MBChB PGCertMedEd FHEA FRCPsych Associate Medical Director, Birmingham and Solihull Mental Health NHS Foundation Trust Chair of Area Prescribing Committee, Birmingham, Sandwell, Solihull and Environs

Professor Naomi Fineberg BA Hons MB BS MA MRCPsych Consultant in General Adult Psychiatry, Hertfordshire Partnership NHS

Dr David Hunt MBMS MRCP PhD Honorary Consultant Neurologist/ Wellcome Trust Clinician Scientist, Anne Rawling Regenerative Neurology Clinic, University of Edinburgh

Dr Barry Mark Miller MB ChB FRCA FFPMRCA Consultant in Pain Medicine and Anaesthesia, Bolton NHS Foundation Trust. Board Member of the Faculty of Pain Medicine.

Professor David G C Owens MD (Hons) FRCP FRCPsych Professor of Clinical Psychiatry, Edinburgh University

Dr Waqar Rashid MBBS BSc MRCP(UK) PhD Consultant and Honorary Clinical Senior Lecturer in Neurology, Brighton and Sussex University Hospitals NHS Trust, member of the Multiple Sclerosis Society

Professor Andrew Rice MB BS, MD, FRCP, FRCA, FFPMRCA Professor of Pain Research, Imperial College London, United Kingdom Honorary Consultant in Pain Medicine, Chelsea and Westminster Hospital, London, England

Dr Fergus Rugg-Gunn MB BS MRCP PhD Consultant Neurologist, National Hospital for Neurology and Neurosurgery, Queen Square, London

Dr Aditya Sharma MBBS MD MRCPsych PhD Clinical Senior Lecturer and Honorary Consultant in Child and Adolescent Psychiatry at Newcastle University and Cumbria, Northumberland Tyne and Wear NHS Foundation Trust

Dr Hoo Kee Tsang BSc(Hons) MB BCh FRCA FFPMRCA Consultant in Pain Medicine and Anaesthesia, Clinical Director of Pain Services, Liverpool University Hospitals NHS Foundation Trust, member of the Royal College of Anaesthetists and the Faculty of Pain Medicine training and assessment committees.

Professor Christopher Weir BSc (Hons) PhD MSc FRSS C.Stat Personal Chair in Medical Statistics and Clinical Trials, Usher Institute, University of Edinburgh

Oncology and Haematology EAG

Remit

To advise the CHM on the safety, quality and efficacy of medicines used in the treatment of malignant disease or blood disorders.

Chair

Professor Poulam Patel PhD, MBBS, FRCP Professor of Clinical Oncology, University of Nottingham

Members

Professor David Bowen MA MB Bchir MD MRCP FRCPath,Consultant Haematologist, Leeds Teaching Hospitals and Honorary Professor of Myeloid Leukaemia Studies, University of Leeds

Professor Janet E Brown FRCP, MD,MSc, BMedSci, MBBS Academic Unit of Clinical Oncology, Department of Oncology and Metabolism, Weston Park Hospital, University of Sheffield.

Professor Stephen Devereux PhD FRCP FRCPath Consultant Haematologist, Kings College Hospital

Dr Hugo Ford MA MB BChir MD FRCP Director of Cancer Services, Cambridge University Hospitals

Dr Rebecca Kristeleit BSc MBChB PhD FRCP FRSB Consultant Medical Oncologist, Guy’s and St Thomas’ NHS Foundation Trust.

Professor Siow Ming Lee PhD FRCP Professor of Medical Oncology, Consultant Medical Oncologist

Professor James Spicer FRCP, PhD Professor of Experimental Cancer Medicine, King’s College London; Consultant in Medical Oncology, Guy’s & St Thomas’ NHS Foundation trust

Meeting dates 2021

March Apr May June July Aug Sept Oct Nov Dec
25 29 20 24 29 26 23 21 18 09

Paediatric Medicines EAG

The remit of the EAG is to advise the CHM on the safety, quality and efficacy of medicines for paediatric use, including all matters relating to the implementation of the EU Paediatric Regulation.

Chair

Professor Steven Cunningham MBChB PhD FRCPCH Professor of Paediatric Respiratory Medicine, University of Edinburgh and Honorary Consultant, Royal Hospital for Children and Young People, NHS Lothian, Edinburgh

Members

Mrs Catrin Barker, Chief Pharmacist, Pharmacy Department, Alder Hey Children’s NHS FT, Eaton Road, Liverpool

Dr Jayesh Mahendra Bhatt MBBS, MD, DCH, FRCPCH, Consultant Respiratory Paediatrician, Nottingham Childrens Hospital

Dr Helen Burdett MB ChB MRCP FRCA , Consultant Anaesthetist, Tunbridge Wells Hospital

Miss Elinor Burrows RGN RSCN MSc , Respiratory Lead Nurse & Nurse Consultant Cystic Fibrosis

Professor J Helen Cross OBE MB ChB PhD FRCP FRCPCH , The Prince of Wales’s Chair of Childhood Epilepsy, Deputy Head of Developmental Neurosciences Programme, UCL Institute of Child Health

Dr Daniel Hawcutt BSc (Hons), MB ChB (Hons), MD, MRCPCH , Senior Lecturer Paediatric Clinical Pharmacology, Women’s and Children’s Health, Institute of Translational Medicine, University of Liverpool

Professor Meriel Jenney MBChB MRCP MD FRCPCH, Consultant Paediatric Oncologist, Clinical Board Director, Clinical Diagnostics and Therapeutics Clinical Board, Assistant Medical Director (Cancer Services), University Hospital of Wales

Dr Kathryn Johnson MBChB FRCPCH, Consultant Neonatologist, Leeds Teaching Hospitals NHS Trust and Honorary Senior Lecturer, Leeds University

Dr Caroline Jones MB ChB FRCPCH MD, Consultant Paediatric Nephrologist, Alder Hey Children’s NHS Foundation Trust

Professor Nigel Klein BSc MBBS MRCP PhD FRCPCH, Consultant, Great Ormond Street Hospital for Children NHS Trust; Professor of Infectious Diseases and Microbiology, Institute of Child Health, UCL

Dr Rubin Minhas MB ChB MBA, GP Principal

Dr Clare Pain BMBS, MSc, MRPCH, Consultant Paediatric Rheumatologist, Clinical Lead for Rheumatology Honorary Clinical Lecturer, University of Liverpool Co-Chair of NIHR CRN: children/Versus Arthritis Paediatric Rheumatology Clinical Studies Group Associate Director, UK Experimental Arthritis Treatment Centre for Children (Behcet’s and scleroderma workstreams)

Ms Sara Payne BA CPE LPC, Lay Representative. Solicitor

Dr Guido Pieles PhD MD, Consultant Congenital Cardiologist, Congenital Hear Unit, Bristol Heart Institute

Professor Heather M Wallace PhD FRCPath FRSC FRS FBTS FBPhS European Registered Toxicologist ERT, Professor of Biochemical Pharmacology and Toxicology, School of Medicine, Medical Sciences and Nutrition, Institute of Medical Sciences, University of Aberdeen.

Dr William John Watkins BSc PhD, Senior Statistician/Lecturer, College of Biomedical & Life Sciences, Cardiff University

Dr Morris Zwi MBBCh, FRCPsych, Consultant Child & Adolescent Psychiatrist and Clinical Lead, Child & Adolescent Mental Health Services, Whittington Health, Child & Adolescent Mental Health Services

Meeting dates

2021

Jan Feb March March Apr May June July Aug Sept Oct Nov Dec
13 10 03 21 28 19 23 28 25 22 20 17 08

Patient and Public Engagement EAG

The Commission on Human Medicines is in the process of identifying a replacement for the previous Expert Advisory Group on Patient and Public Engagement. This will include refreshing the Group’s remit and objectives. Further details will be added to this page in due course.

Pharmacovigilance EAG

PEAG now review applications for access to Type II Yellow Card data, the completed application form should be emailed directly to pharmacovigilanceservice@mhra.gov.uk

Remit

To advise the CHM on the following in relation to human medicines including herbal products:

  • the public health importance of potential new signals
  • the confirmation and quantification of risks identified
  • appropriate risk minimisation measures including communications
  • design and progress of pharmacovigilance plans
  • methodologies for pharmacovigilance.

Interim Chair

Professor Jamie Coleman MD MA (Med Ed) FRCP FBPhS Professor in Medical Education/Consultant Clinical Pharmacologist, University of Birmingham

Members

Professor Darren Ashcroft BPharm MSc PhD FRPharmS Professor of Pharmacoepidemiology, Division of Pharmacy and Optometry, Manchester University

Professor Ann Daly BA PhD FBPhS Professor of Pharmacogenetics, Faculty of Medical Sciences, Newcastle University

Dr Dan Hawcutt BSc MB ChB MD MRCPCH Senior Lecturer in Paediatric Clinical Pharmacology, Women’s and Children’s Health, Institute of Translational Medicine, University of Liverpool.

Professor Ian J Douglas BSc MSc PhD Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine

Dr Karen Miller BSc MBBS DRCOG DCH DFFP FRCGP GP Partner, Adelaide Medical Centre, London

Dr Rupert Payne MB ChB MRCP PhD MRCGP FRCP, Consultant Senior Lecturer in Primary Care, University of Bristol

Dr Ruben Thanacoody PGCertEd MD FRCP FRCP(Edin) Consultant Physician, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Honorary Clinical Senior Lecturer in Clinical Pharmacology, Newcastle University Honorary Consultant Clinical Toxicologist, Public Health England , Director National Poisons Information Service (Newcastle unit)

Ms Susan Hunneyball BSc (Hons) Lay Member

Dr Mark Glover BA MA MB BChir MRCP PhD Associate Professor and Honorary Consultant Physician, Clinical Pharmacology and General Medicine, University of Nottingham

Mrs Alana Adams BPharm (Hons), MSc, IP, MRPharmS
Principal Pharmacist Medicines Information, advice and Safety, University of Cardiff

Dr Richard FitzGerald MD MBChB PhD FRC
CRF Director, NIHR Royal Liverpool and Broadgreen CRF

Dr Patricia McGettigan MD, BSc, MB, BCh, BAO, BA
Reader in Clinical Pharmacology and Medical Education and Consultant Physician, Barts Health Trust

Mrs Madeleine Wang
(Lay Representative – Patient advocate)

Meeting dates

2021

Jan Feb March March Apr May June July Aug Sept Oct Nov Dec
14 11 03 31 28 20 24 29 25 23 21 18 09

Type II Yellow Card data

PEAG now review applications for access to Type II Yellow Card data, the completed application form should be emailed directly to pharmacovigilanceservice@mhra.gov.uk

CTBV21-2 Advert - CHM Clinical Trials Biologicals and Vaccines Expert Advisory Group (PDF, 80.2 KB, 2 pages)

Sodium Valproate Expert Working Group

Terms of reference of the Sodium Valproate expert Working Group

  • To review the current risk minimisation in place and possible reasons for lack of effectiveness.
  • To consider further regulatory measures required to minimize the risk of valproate use in pregnancy including, but not limited to, a contraindication for use in pregnancy in girls and women without effective contraception and a formal Pregnancy Prevention Program.
  • To consider other measures required across the healthcare system to ensure compliance with regulatory position in clinical practice (e.g. shared care agreements, registries.

Chair

Professor Sir Munir Pirmohamed MB ChB (Hons) PhD FRCP FRCP (Edin) FBPhS, FFPM (Hon) FMedSci David Weatherall Chair of Medicine, University of Liverpool, NHS Chair of Pharmacogenetics, Director of the Wolfson Centre for Personalised Medicine, Director of the MRC Centre for Drug Safety Science

Members

Professor J Helen Cross OBE MB ChB PhD FRCP FRCPCH The Prince of Wales’s Chair of Childhood Epilepsy, Deputy Head of Developmental Neurosciences Programme, UCL Institute of Child Health

Dr Martin Duerden B Med Sci, MB BS, DRCOG, Dip Ther, DPH, FRCGP Member of National Stakeholder Platform, Honorary Senior Research Fellow, Centre for Health Economics and Medicines Evaluation, Bangor University

Professor Jayne Lawrence Professor of Biophysical Pharmaceutics, Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester University and Visiting Professor of Biophysical Pharmaceutics, Institute of Pharmaceutical Science, King’s College London

Dr John Paul Leach Honorary Associate Clinical Professor, School of Medicine, Dentistry and Nursing, University of Glasgow, Elected Member of the Association of British Neurologists (ABN)

Dr Janine Lynch BHSCT Psychiatrist, Belfast Health & Social Care Trust

Dr Rebecca Mann BMBS FRCPCH Consultant Paediatrician, Taunton and Somerset NHS Foundation Trust

Dr Karen Miller BSc MBBS DRCOG DCH DFFP FRCGP GP Partner, Adelaide Medical Centre, London

Professor Catherine Nelson-Piercy MBBSMA, FRCP, FRCOG Professor of Obstetric Medicine and Consultant Obstetric Physician, Guy’s & St Thomas’ Foundation Trust

Professor David G C Owens MD (Hons) FRCP FRCPsych Professor of Clinical Psychiatry, Edinburgh University

Ms Clare Pelham Chief Executive of the Epilepsy Society

Dr Fergus Rugg-Gunn MB BS MRCP PhD Consultant Neurologist, National Hospital for Neurology and Neurosurgery, Queen Square, London

Professor Philip Smith Consultant Neurologist, Cardiff School of Medicine and former President of the Association of British Neurologists (ABN)

Mrs Madeleine Wang BA (Hons) Lay Representative. Patient Advocate

Invited expert

Professor Thomas R. E. Barnes MD FRCPsych DSc Professor of Clinical Psychiatry, Imperial College London

Opioids Expert Working Group

Terms of reference

The review will:

  • consider the current data on the utilisation of opioid-containing medicines in the UK, both prescribed and over the counter
  • examine whether the risk minimisation measures implemented for over the counter and prescription opioids have been effective or whether further measures are required
  • consider the benefit/risk of opioid-containing medicines in particular for non-cancer indications, taking into account alternatives
  • make recommendations for regulatory action to better support appropriate use of prescription opioids, such as relevant changes to the Summary of Product Characteristics and Patient Information Leaflets, product labelling and packaging, and any other risk minimisation measures

Chair

Professor Jamie Coleman MD MA (Med Ed) FRCP FBPhS Professor in Medical Education / Consultant Clinical Pharmacologist, University of Birmingham

Members

Dr Eileen M Baildam MB ChB DRCOG DCH RCP FRCP FRCPCH Consultant Paediatric Rheumatologist and Honorary Senior Lecturer, Alder Hey Foundation NHS Trust and University of Liverpool

Dr Helen Burdett MB ChB MRCP FRCA Consultant Anaesthetist, Tunbridge Wells Hospital

Dr Lesley Colvin Chair in Pain Medicine, University of Dundee/ Consultant in Anaesthesia & Pain Medicine, NHS Tayside, Deputy Head of Division, Population Health and Genomics, Hon. Professor in Pain Medicine, University of Edinburgh

Professor Peter Crome MD PhD DSc FRCP FFPM FBPharmacolS Emeritus Professor, Keele University, Honorary Professor, UCL

Dr Jamie Fraser BSc MB ChB MRCGP GP Partner, Southside Surgery, Inverness

Professor Philip Hannaford MB ChB DRCOG DCH MD FRCGP FFSRH FFPH Professor of Primary Care, University of Aberdeen

Dr Karen Miller BSc MBBS DRCOG DCH DFFP FRCGP GP Partner, Adelaide Medical Centre, London (Apologies)

Professor David G C Owens MD (Hons) FRCP FRCPsych Professor of Clinical Psychiatry, Edinburgh University

Dr Catherine F Stannard MB ChB FRCA FFPMRCA Consultant in Complex Pain/Pain Transformation Programme Clinical Lead, NHS Gloucestershire CCG (also sitting on PHE review board)

Professor Ash Soni OBE FFRPS FRPharmS LPN Pharmacy Chair (London); Executive & Council Member, National Association of Primary Care; English Pharmacy Board Member, Royal Pharmaceutical Society; Pharmacy Clinical Network Lead, Lambeth CCG

Mr Steve Taylor Programme Manager, PHE Alcohol, Drugs, Tobacco & Justice

Dr J P Thompson BMedSci MBChB FRCP FBTS FEAPCCT Clinical Senior Lecturer, Department of Pharmacology, Therapeutics & Toxicology, Cardiff University, and Director NPIS Cardiff Unit

Mrs Madeleine Wang BA (Hons) Lay Representative. Patient Advocate

Mrs Helen M Ward MSc, BSc (Hons), Senior Fellow HEA, RGN, RCN Nurse Practitioner, PGCEA, PG Cert NMP Queens Nurse, Advanced Nurse Practitioner

Professor Christopher Weir BSc (Hons) PhD MSc FRSS C.Stat C. Sci Personal Chair in Medical Statistics and Clinical Trials, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh

Dr Frances Williams BSc MBBS MRCP PhD CCST FRCP (Edin) Reader in Genetic Epidemiology and Hon Consultant Rheumatologist, King’s College London

Observer

Mr Steve Taylor Programme Manager, PHE Alcohol, Drugs, Tobacco & Justice

Isotretinoin Expert Working Group

Terms of reference

The terms of reference for the IEWG are:

  • to evaluate information from all available sources, including relevant stakeholders (patients, patient representatives, healthcare professionals, healthcare organisations, researchers, charity and patient organisations) on psychiatric effects suspected to be associated with isotretinoin. To consider whether regulatory action is required to minimise risk and ensure awareness of the risks.
  • to evaluate information from all available sources, including relevant stakeholders (patients, patient representatives, healthcare professionals, healthcare organisations, researchers, charity and patient organisations) on sexual disorders suspected to be associated with isotretinoin. To consider whether regulatory action is required to minimise risk and ensure awareness of the risks.
  • to consider the impact of the available information on psychiatric effects and sexual disorders on the balance of benefits and risks of isotretinoin.
  • to consider what research could be undertaken to further elucidate any risks and long-term impact of psychiatric effects and sexual disorders and inform risk minimisation measures.
  • to make recommendations to the Commission on Human Medicines to improve the balance of benefits and risks for isotretinoin, to raise awareness of the associated risks and for further research to evaluate the risks.

Chair

Professor Angela Thomas OBE MB BS PhD FRCPE FRC Path
University of Edinburgh

Members

Professor Darren Ashcroft BPharm, MSc, PhD, FRPharmS Professor of Pharmacoepidemiology, Head, Drug Usage and Pharmacy Practice Group, University of Manchester

Professor Amanda Drake FRCPE Personal Chair of Epigenetics and Metabolism, Academic Director, Academic Foundation Programme, Associate Director, Edinburgh Clinical Academic Training Programme

Professor Nicol Ferrier BSc MB ChB MD FRCP FRCPsych Professor of Psychiatry and Honorary Consultant Psychiatrist, University of Newcastle

Dr Arianna Di Florio Clinical Senior Lecturer, Cardiff University Honorary Consultant Psychiatrist, Cardiff and Vale University Health Board, Adjunct Assistant Professor, University of North Carolina at Chapel Hill

Dr Clive Grattan BA MA MB BChir FRCP MD ILT Consultant Dermatologist, St John’s Institute of Dermatology, Guy’s Hospital, London

Professor David Gunnell MB ChB MRCGP PhD MSc FFPHM Professor of Epidemiology, University of Bristol

Professor Peter C Hindmarsh Professor of Paediatric Endocrinology, University College London

Dr Karen Miller BSc MBBS DRCOG DCH DFFP FRCGP
GP Partner, Adelaide Medical Centre, London

Professor Rod Mitchell Professor of Developmental Endocrinology, Honorary Consultant Paediatric Endocrinologist, UKRI Future Leaders Fellow/Academic Lead for Public Engagement MRC Centre for Reproductive Health, Queens Medical Research Institute, Edinburgh

Professor Gudrun Moore Professor of Clinical and Molecular Genetics, Genetics and Genomic Medicine, UCL Great Ormond Street Institute of Child Health

Mr Giangiacomo Ollandini FRCS MD Milton Keynes Hospital NHS Foundation Trust - Urology Urologist, Andrologist, MSc in andrological surgery and gender disorder

Ms Linda Pepper BA MA (Education) Independent Consultant: patient and public involvement in healthcare

Dr Amr Abdel Raheem MB BCh, MSc, DipSurg, PhD, FECSM, FEAA University College London Hospitals NHS Foundation Trust infertility & contraception, Peyronies Disease, Erectile Dysfunction and male Hypogonadism

Mrs Madeleine Wang BA (Hons) Lay Representative, Patient Advocate

Professor Allan Young Vice Dean, Academic Psychiatry (Interim), Director, Centre for Affective Disorders NIHR Senior Investigator, Academic Director, Psychological Medicine and Older Adults Clinical Academic Group, Immediate Past President of International Society for Affective Disorders, President British Association for Psychopharmacology, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King’s College London

Observers

National Institute for Health and Care Excellence (NICE)

NHS Improvement

The Care Quality Commission

Primary Care Dermatology Society (PCDS)

COVID-19 Therapeutics Expert Working Group

Remit

  • To advise on the safety and efficacy of candidate anti-viral agents, immune-based therapies and repurposed agents for the treatment and prevention of COVID-19 infection, based on available scientific data.
  • To review the robustness of the evidence of supporting agents used for the treatment of COVID-19 complications, including agents based on putative mechanisms, as currently available and based on emerging data.
  • To advise on strategies and study designs to collect efficacy and safety data including novel trial designs.
  • To advise on measures to minimise risks and optimise the benefit-risk balance of anti-viral agents, supportive therapies (e.g., corticosteroids, NSAIDS, chloroquine, immune modulators, etc) proposed for the treatment of COVID-19 infection and its complications.
  • To advise on the benefits and risk of concomitant medications (e.g., ACE inhibitors/ AT-II blockers or immunosuppressants).
  • To advise on measures to monitor safety and effectiveness of risk minimisation measures relating to these medicinal products.
  • To advise the Commission on Human Medicines.

Chair

Professor Jonathan S Friedland MA PhD FRCP FRCPE FRCPI FESCMID FMedSci Deputy Principal, St. George’s, University of London

Members

Professor Kenneth Baillie BSc(Hons) MBChB PhD FRCA FRCP FFICM
Professor of Experimental Medicine Roslin Institute, University of Edinburgh

Ms Susan Bradford Lay Representative

Professor David Dockrell MB BCh MD FRCPI FRCP (Glas) FACP Professor of Infection Medicine, University of Edinburgh

Professor Richard J C Gilson MD FRCP Professor of Sexual Health & HIV Medicine, Director of the UCL Centre for Clinical Research in Infection & Sexual Health & Deputy Director of the UCL Institute for Global Health

Sir Michael Jacobs Consultant & Hon. Senior Lecturer in Infectious Diseases Royal Free London NHS Foundation Trust

Professor Nigel Klein BSc MBBS MRCP PhD FRCPCH Consultant, Great Ormond Street Hospital for Children NHS Trust; Professor of Infectious Diseases and Microbiology, Institute of Child Health, UCL

Dr Siraj Misbah MBBS (Hons) MSc FRCP FRCPath - Consultant Clinical Immunologist, Lead for Clinical Immunology, Oxford University Hospitals

Professor B Kevin Park BSc PhD FMedSci HonFRCP FBTS HonFBPhs Professor of Pharmacology, University of Liverpool

Professor Deenan Pillay Professor of Virology, UCL Pro-Vice-Provost International

Professor Sir Munir Pirmohamed MB ChB (Hons) PhD FRCP FRCP (Edin) FBPhS, FFPM (Hon) FMedSci David Weatherall Chair of Medicine, University of Liverpool, NHS Chair of Pharmacogenetics, Director of the Wolfson Centre for Personalised Medicine, Director of the MRC Centre for Drug Safety Science

Professor Shirley Price MSc, PhD, FBTS, FRSB, ERT, FHEA ,FRSC, MBPharmacolSoc Emerita Professor of Toxicology, University of Surrey Visiting Profesor of Toxicology, University of Hertfordshire

Observers

Professor Stuart Ralston MB ChB MD FRCP FMedSci FRSE FFPM (Hon) Professor of Rheumatology, University of Edinburgh, Western General Hospital, Edinburgh

Department of Health & Social Care

Public Health England

NHS England & NHS Improvement

National Institute for Health and Care Excellence (NICE)

COVID-19 Vaccines Safety Surveillance Methodologies Expert Working Group

Remit

Pre-deployment phase

  • To landscape the different healthcare datasets that are currently available in the UK to capture near real-time information on COVID-19 vaccine exposure and study endpoints relevant to vaccine safety and potential for disease enhancement (and effectiveness). This should take into account a range of potential scenarios for vaccine deployment (i.e. the point of administration and any prioritised/targeted immunisation), and should advise on the need for further data capture and linkage.
  • To advise on the most suitable study endpoints and design(s) to monitor COVID-19 vaccine safety, and potential for disease enhancement (and effectiveness).
  • To support engagement with UK institutions who may be planning/in a position to conduct COVID-19 vaccine safety studies. This is to encourage and facilitate studies that are complementary in terms of objective and design, to avoid duplication and to accommodate a suitable range of study endpoints and scenarios for vaccine deployment.
  • To advise on proposals for enhanced passive surveillance.
  • To advise on communications in support of the pharmacovigilance strategy.

Post-deployment phase

  • To advise on the emerging evidence from all data sources on the risks and benefits of vaccine(s) during the course of any COVID-19 immunisation campaign in the UK. This includes measures to minimise risks, and optimise the benefit-risk balance for individual vaccines, such as any new precautions or restrictions on use.
  • To advise on any communications to health professionals and the public.
  • To advise on measures to monitor impact/effectiveness of any additional risk minimisation.

Chair

Dr Siraj Misbah MBBS (Hons) MSc FRCP FRCPath Consultant Clinical Immunologist, Lead for Clinical Immunology, Oxford University Hospitals & Chair of the Clinical Trials, Biologicals & Vaccines Expert Advisory Group (CTBVEAG) & Member of the Commission on Human Medicines (CHM)

Members

Professor Ian J Douglas BSc MSc PhD Senior Lecturer in Pharmacoepidemiology, London School of Hygiene & Tropical Medicine & Member of the Pharmacovigilance Expert Advisory Group (PEAG)

Professor Jonathan S Friedland MA PhD FRCP FRCPE FRCPI FESCMID FMedSci Deputy Principal, St. George’s, University of London & Chair of the Infections Expert Advisory Group (IEAG) & Member of the Commission on Human Medicines (CHM)

Sir Michael Jacobs MA PhD MB BS FRCP FRCP Edin DTM&H Clinical Director of Infection, Royal Free London NHS Foundation Trust & Hon. Senior Lecturer, Liverpool School of Tropical Medicine

Professor Simon De Lusignan Professor of Primary Care and Clinical Informatics, University of Oxford

Dr Rupert Payne PhD MRCGP FRCPE FBPhS Consultant Senior Lecturer in Primary Care, University of Bristol & Member of the Pharmacovigilance Expert Advisory Group (PEAG)

Professor Sir Munir Pirmohamed MB ChB (Hons) PhD FRCP FRCP (Edin) FBPhS, FFPM (Hon) FMedSci David Weatherall Chair of Medicine, University of Liverpool, NHS Chair of Pharmacogenetics, Director of the Wolfson Centre for Personalised Medicine, Director of the MRC Centre for Drug Safety Science

Professor Siobhan Quenby MBBS BSc MD FRCOG Professor of Obstetrics, Warwick University & Member of the Medicines for Women’s Health Expert Advisory Group (MWHEAG)

Professor Chris Robertson PhD MSc BSc Professor of Public Health Epidemiology, University of Strathclyde

Professor Calum Semple PhD FRCPCH FRCPE FHEA Professor of Outbreak Medicine University of Liverpool

Invited Experts

Professor Elizabeth Miller Department of Infectious Disease Epidemiology, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine

Professor Anthony Scott JCVI member, and Professor of vaccine epidemiology, Director HPRU in immunisation

Helen McDonald LSHTM Health Protection Research Unit

Jemma Walker LSHTM Health Protection Research Unit

Observers

Professor Liam Smeeth MBChB FRCGP FRCP MSc PhD FMedSci Professor of Clinical Epidemiology, London School of Hygiene & Tropical Medicine (LSHTM) & MHRA, Non-Executive Director (Board)

Visiting Experts

Professor Andrew Pollard FRCPCH PhD FMedSci Chief Investigator of the Oxford ChAD vaccine

Professor of Paediatric Infection and Immunity, Director of Graduate Studies, Department of Paediatrics, Vice Master, St Cross College, University of Oxford & Member of the Clinical Trials, Biologicals & Vaccines Expert Advisory Group (CTBVEAG)

Professor Robin Shattock Lead Scientist for the Imperial saRNA vaccine programme

Professor Sheena McCormack Clinical Project Lead at MRC CTU at UCL

COVID-19 Vaccines Benefit Risk Expert Working Group

Remit

  • To advise CHM on the quality, safety and efficacy of COVID-19 vaccines and on the balance of benefit and risks prior to authorisation.
  • To coordinate safety evaluation with the Clinical Trials, Biologicals and Vaccines Expert Advisory Group.
  • To report its conclusions and recommendations to the Commission on Human Medicines.
  • To advise on the emerging evidence from all data sources on the risks and benefits of vaccine(s) during the course of any COVID-19 immunisation campaign in the UK. This includes measures to minimise risks, and optimise the benefit-risk balance for individual vaccines, such as any new precautions or restrictions on use.
  • To advise on any communications to health professionals and the public.
  • To advise on measures to monitor impact/effectiveness of any additional risk minimisation.

Chair

Professor Sir Munir Pirmohamed MB ChB (Hons) PhD FRCP FRCP (Edin) FBPhS, FFPM (Hon) FMedSci David Weatherall Chair of Medicine, University of Liverpool, NHS Chair of Pharmacogenetics, Director of the Wolfson Centre for Personalised Medicine, Director of the MRC Centre for Drug Safety Science

Members

Professor Judith Breuer MD FRCPath FmedSci Professor of Virology, University College London (UCL), Division of Infection and Immunity, London

Professor Gordon Dougan FRS Department of Medicine, Cambridge Infectious Diseases, University of Cambridge

Professor Neil French MB ChB FRCP PhD Head Department of Clinical Infection Microbiology and Immunology, Chair of Infectious Diseases & Global Health, Hon Consultant Infectious Diseases, Royal Liverpool & Broadgreen University Hospitals Trust

Professor David Goldblatt MB ChB FRCPCH FRCP PhD Professor of Vaccinology and Immunology, Consultant in Paediatric Immunology, NIHR Senior Investigator, Great Ormond Street Hospital & University College London

Ms Susan Hunneyball BSc Lay Member, Member of the Pharmacovigilance Expert Advisory Group (PEAG) and Advisory Board on the Registration of Homeopathic Products (ABRHP)

Professor Kimme Hyrich MD PhD FRCPC Professor of Epidemiology and Honorary Consultant in Rheumatology, Centre for Musculoskeletal Research, Faculty of Biology Medicine and Health, University of Manchester and Kellgren Centre for Rheumatology, Manchester University NHS Foundation Trust

Sir Michael Jacobs MA PhD MB BS FRCP FRCP Edin DTM&H Clinical Director of Infection, Royal Free London NHS Foundation Trust, Hon. Senior Lecturer, Liverpool School of Tropical Medicine & Member of the CHM Covid-19 Vaccine Expert Working Group

Professor Helen J Lachmann MA MB BChir MD FRCP FRCPath Professor of Medicine & Honorary Consultant Nephrologist Clinical Director UCL Division of Medicine & Clinical Lead for National Amyloidosis Centre, University College London & Royal Free Hospital London NHS Foundation Trust & Vice-chair of the Clinical Trials, Biologicals & Vaccines Expert Advisory Group (CTBVEAG)

Professor Paul J Lehner PhD FRCP FMedSci Professor of Immunology and Medicine, Wellcome Trust Principal Research Fellow Honorary Consultant Infectious Diseases, Cambridge Institute of Therapeutic Immunology and Infectious Disease (CITIID), Jeffrey Cheah Biomedical Centre Cambridge Biomedical Campus

Dr Siraj Misbah MBBS (Hons) MSc FRCP FRCPath Consultant Clinical Immunologist, Lead for Clinical Immunology, Oxford University Hospitals & Member of the Commission on Human Medicines (CHM) & Chair of the Clinical Trials, Biologicals & Vaccines Expert Advisory Group (CTBVEAG)

Professor Shirley Price MSc, PhD, FBTS, FRSB, ERT, FHEA ,FRSC, MBPharmacolSoc Emerita Professor of Toxicology, University of Surrey Visiting Professor of Toxicology, University of Hertfordshire

Dr Andrew Riordan MD FRCPCH DTM&H Consultant in Paediatric Infectious Diseases and Immunology, Honorary Clinical Lecturer, University of Liverpool, Alder Hey Children’s NHS Foundation Trust, Liverpool

Professor Chris Robertson PhD MSc BSc Professor of Public Health Epidemiology, University of Strathclyde

Professor Tom Solomon FRCP PhD Chair, Neurological Science and Director, NIHR Health Protection Research Unit in Emerging and Zoonotic Infections, University of Liverpool, Hon Consultant Neurologist, Walton Centre NHS Foundation Trust

Dr Robin Thorpe BSc PhD FRCPath Retired, Head, Division of Biotherapeutics, National Institute for Biological Standards and Control (NIBSC) & Member of the Clinical Trials, Biologicals & Vaccines Expert Advisory Group (CTBVEAG)

Mrs Madeleine Wang BA (Hons) Lay Member & Member of the Clinical Trials, Biologicals & Vaccines Expert Advisory Group (CTBVEAG)

Professor Christopher Weir BSc MSc PhD FRSS Cstat Professor of Medical Statistics & Clinical Trials, Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh & Member of Commission on Human Medicines (CHM) & Member of the Clinical Trials, Biologicals & Vaccines Expert Advisory Group (CTBVEAG)

Invited Members of The Clinical Trials, Biologicals & Vaccines Expert Advisory Group (CTBV EAG)

Professor B Kevin Park BSc, PhD, Hon FRCP, FMedSci, FBTS, HonFBPhS Professor of Pharmacology, Department of Pharmacology, University of Liverpool

Professor Marc Turner MBBS PhD MBA FRCP FRCPath FHEA Professor of Cellular Therapy; Medical Director Scottish National Blood Transfusion Service (SNBTS)

Invited Members of The Chemistry, Pharmacy and Standards Expert Advisory Group (CPS EAG)

Professor Kevin M G Taylor BPharm PhD FRPharmS (Chair) Chair of the British Pharmacopoeia Commission and Professor of Clinical Pharmaceutics, UCL School of Pharmacy, London

Mr V’Iain G Fenton-May BPharm MIPharm FRPharmS Pharmaceutical Microbiologist

Mr Robert Lowe BPharm FRPharmS Practising Hospital Pharmacist, Specialist Pharmacy Services - East of England

Professor Yvonne Perrie BSc Hons MRPharmS FAPS FSB PhD Chair in Drug Delivery, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow. Scotland

Professor Susannah E Walsh PhD BSc MBA Associate Head School of Pharmacy, Professor of Pharmaceutical Microbiology, Leicester School of Pharmacy, De Montfort University, Leicester

Observer

Professor Stuart Ralston MB ChB MD FRCP FMedSci FRSE FFPM (Hon) Professor of Rheumatology, University of Edinburgh, Western General Hospital, Edinburgh

Invited Experts (participation at specific meetings only)

Professor Ian J Douglas BSc MSc PhD Senior Lecturer in Pharmacoepidemiology, London School of Hygiene & Tropical Medicine & Member of the Pharmacovigilance Expert Advisory Group (PEAG)

Professor Paul-Henri Lambert MD Senior Adviser, Centre of Vaccinology, University of Geneva, Department of Pathology and Immunology, CMU

Professor Linda Sharples PhD Professor of Medical Statistics, London School of Hygiene & Tropical Medicine (LSHTM) and Faculty of Epidemiology and Population Health

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