The CHM meeting date on March 2024 is shown as on March 14 2024. I wonder?
2024
Jan Feb March Apr May June July Aug Sept Oct Nov Dec
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Type II Yellow Card data
PEAG now review applications for access to Type II Yellow Card data. The completed Type II Yellow Card data application form should be emailed directly to vigilanceservice@mhra.gov.uk.
Application Form (PDF, 173 KB, 10 pages)
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 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
Professor Rupert Payne MB ChB PhD MRCGP FRCPE FBPhS FHEA Professor of Primary Care & Clinical Pharmacology, University of Exeter. 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 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 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
Mr V’Iain G Fenton-May BPharm MIPharm FRPharmS, Pharmaceutical Microbiologist
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(Hons), 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, Consultant in Infectious Diseases, Royal Free London NHS Foundation Trust; Hon. Senior Lecturer, University College London and Liverpool School of Tropical Medicine
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 FRS
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
Mr Robert Lowe BPharm FRPharmS, Practising Hospital Pharmacist, Specialist Pharmacy Services - East of England
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 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, MBPharmacolSoc, Emerita Professor of Toxicology, University of Surrey, Visiting Professor of Toxicology, University of Hertfordshire and Member of the Commission on Human Medicines (CHM)
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 Kevin M G Taylor BPharm PhD FRPharmS, Chair of the British Pharmacopoeia Commission and Professor of Clinical Pharmaceutics, UCL School of Pharmacy, London
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)
Professor Marc Turner MBBS PhD MBA FRCP FRCPath FHEA, Professor of Cellular Therapy; Medical Director Scottish National Blood Transfusion Service (SNBTS)
Professor Susannah Walsh BSc PhD MBA, Head of School, Professor of Pharmaceutical Microbiology, Pharmacy and Life Sciences, Robert Gordon University
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)
Cancer Vaccines Expert Working Group
Remit
To advise CHM on the quality, safety and efficacy of candidate personalised cancer vaccines.
To advise CHM on the quality, non-clinical and clinical development of personalised cancer vaccines.
To advise on the measures to characterise the clinical effectiveness of personalised cancer vaccines in the clinical use setting.
To advise on the measures to monitor short-term & long-term safety and minimise the risks of personalised cancer vaccines.
To advise on healthcare practitioner and patient communications related to personalised cancer vaccines.
To advise on the regulatory nomenclature of cancer vaccines and immunotherapy.
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 Centre for Drug Safety Science
Members
Dr Robert Andrews Senior Lecturer FHEA, Data Hub at Heath, Cardiff
Dr Colin Brown PhD FRCPath Consultant Clinical Scientist, Head of H&I Laboratory Colindale, NHS Blood and Transplant
Professor Robert Brown BSc PhD Professor of Translational Oncology, Department of Surgery & Cancer, Imperial College London
Dr Peter Buckle FRSPH, FIEHF, FIEA, C.ErgHF Principal Research Fellow, NIHR London In Vitro Diagnostics Co-operative Department of Surgery and Cancer, Faculty of Medicine, Imperial College London
Professor Tom Clutton-Brock MBE MB ChB FRCP FRCA Director, Medical Devices Testing and Evaluation Centre, Clinical Director, NIHR Trauma Management MedTech Cooperative, Chair, NICE Interventional Procedures Advisory Committee, Associate Medical Director, University Hospitals Birmingham NHS Foundation Trust, Professor of Anaesthesia & Intensive Care Medicine, University of Birmingham
Professor Jamie Coleman MD MA (Med Ed) FRCP FBPhS Professor in Medical Education/Consultant Clinical Pharmacologist, University of Birmingham
Mrs Julia Cons Lay Representative
Professor Ann Daly BA PhD FBPhS Professor of Pharmacogenetics, Faculty of Medical Sciences, Newcastle University
Professor Jon Deeks PhD CStat Professor of Biostatistics Public Health, Epidemiology and Biostatistics, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham
Dr Brendan Fish BSc PhD Director of Biologics & RNA Centre of Excellence
Professor Eric Lim MB ChB MD MSc FRCS(C-Th) Consultant Thoracic Surgeon, Royal Brompton Hospital, Professor of Thoracic Surgery, Imperial College London
Mr Robert Lowe BPharm FRPharmS Practising Hospital Pharmacist, Specialist Pharmacy Services - East of England
Dr David Millrine PhD Translational Immunology Team lead, CRUK Cancer Biomarker Centre, University of Manchester
Professor Christian Ottensmeier MD, PhD, FRCP. Professor of Molecular and Clinical Cancer Medicine, University of Liverpool
Professor Poulam Patel PhD, MBBS, FRCP Professor of Clinical Oncology, University of Nottingham
Professor Yvonne Perrie BSc PhD Professor in Drug Delivery within the Strathclyde Institute of Pharmacy and Biomedical Sciences
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
Professor Jacqui Shaw BSc PhD Group Leader and Professor of Translational Cancer Genetics, Leicester University
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
Professor Nigel Stallard Professor of Medical Statistics, Deputy Director Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry
Professor Kevin M G Taylor BPharm PhD FRPharmS Emeritus Professor of Clinical Pharmaceutics, UCL School of Pharmacy, London
Dr Robin Thorpe BSc PhD FRCPath Retired, Head, Division of Biotherapeutics, National Institute for Biological Standards and Control (NIBSC)
Dr David Turner PhD FRCPath H&I Laboratory, Scottish National Blood Transfusion Service, Royal Infirmary of Edinburgh
Professor Marc Turner MBBS PhD MBA FRCP FRCPath FHEA Professor of Cellular Therapy, Medical Director Scottish National Blood Transfusion Service
Professor Christopher Weir BSc MSc PhD FRSS Cstat Professor of Medical Statistics & Clinical Trials, Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh
Professor Anthony Williams BSc MSc MRCP, FRCPath, PhD Professor of Translational Medicine and Honorary Consultant in Clinical Immunology and Allergy, University of Southampton, and University Hospital Southampton NHS Trust
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 [Cancer UK/ UK CI]
Professor Christopher Yau MA MEng DPhil Professor of Artificial Intelligence, Nuffield Department of Women’s & Reproductive Health, University of Oxford, and Health Data Research UK
Professor Ly-Mee Yu BSc MSc DPhil Professor of Clinical Trials and Biostatistics, Deputy Director Academic of Primary Care Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University of Oxford
Observers
Professor Peter Johnson National Clinical Director for Cancer, England
Dr Jayne Spink Prostate Cancer Research
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