Since becoming Chief Executive Officer of the BioIndustry Association in 2012, Steve Bates has led major campaigns for improved access to finance, the refilling of the Biomedical Catalyst, anti-microbial resistance and the opportunity the sector presents to generalist long term investors. He champions the adaptive pathway approach to the licensing of new drugs, Early Access and is very proud of the working relationship the BIA has established with the UK’s leading medical research charities. Steve is a member of EuropaBio’s Board and its National Association Council and is a founder member and Vice-Chair of the International Council of Biotech Associations. In 2016’s New Year’s Honours List he received an OBE for services to Innovation.

Elizabeth Kuiper is currently Executive Director for Public Affairs at EFPIA, where she leads the advocacy and public affairs of EFPIA and maintains a strong network of contacts with policymakers and other stakeholders. Elizabeth previously worked as attaché at the Permanent Representation of the Netherlands to the EU, where she represented the Netherlands in EU negotiations in the field of health, pharmaceuticals and medical devices. Prior to this, Elizabeth worked as political adviser to the Minister of Health, Welfare and Sports in the Dutch cabinet Balkenende-IV, delivering special advice and support on healthcare policy related subjects. Elizabeth studied at the University of Utrecht and holds an MA in Dutch language and literature.

Alan leads the MSD international regulatory organization across EMEA, Canada, Latin America and Asia Pacific. He is a part of the Global Regulatory Affairs & Clinical Safety leadership team, also working with international cross-divisional leaders from across the business on the overall strategy and direction of the ex-US business & organization. Previously, Alan also held leadership positions in global regulatory affairs at several multinational companies. He is active in professional qualification and membership societies, including PhRMA and EFPIA. Holds a B.Sc. in Biology & Physiology from the University of Stirling. Alan acts on several trade association committees related to biotechnology/biopharmaceuticals.

Aimad Torqui has been the Division Head at the Medicines Evaluation Board since September 2022. His role encompasses overseeing (national)policy and European affairs, regulatory science, representation in EU committees, promoting the better use of medicines and veterinary medicines.

Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined MSD in 2017 to lead regulatory policy efforts ex-US for innovation that leads to better treatment for patients globally. Since 2020 this scope has expanded, as Ginny now leads the talented and experienced Global Regulatory Policy and Intelligence team for MSD. Her work has regularly focused on policy shocks that challenge innovation and access to novel therapies for patients, including global and industry-wide policy work on BREXIT, COVID-19 and now the R&D impacts of the Inflation Reduction Act.

Vicki, a qualified pharmacist, began her career in hospital pharmacy and later specialized in Drug Information Services, setting up Kuwait's first National Drug Information Centre. After returning to the UK and spending four years in community pharmacy, she transitioned to pharmacovigilance, joining Abbott as EU QPPV in 2005. She stepped down as AbbVie EU QPPV in 2018 due to Brexit. Now, as Head of PV Excellence and International QPPV, Vicki oversees the QPPV Office, Global Safety Compliance, and Risk Management. She is passionate about pharmacovigilance and developing teams.

Zamshed Harun is Head of European Regulatory and R&D Policy at Amgen. In this role, he provides counsel and strategic advice to embed awareness of policy and regulation within Amgen. He has worked with governments, regulators, trade bodies and other external stakeholders to shape robust science-based regulatory and safety policy. He is currently a member of EFPIA’s Scientific, Regulatory and Manufacturing technical group on Brexit-related issues. He has over 12 years’ experience working in health and regulatory policy within both the pharmaceutical industry and consultancy, as well as in the UK government. Notably, Zamshed spent 10 years at the MHRA specialising in medicines safety and has intimate knowledge of Westminster and Brussels.

Peter O’Donnell has been covering European affairs for over twenty years, for The Financial Times, The Sunday Times, Reuters, the Economist Intelligence Unit, UPI, Euronews, and many other media in Europe and beyond. A former editor-in-chief of Europe Information Service, and former associate editor of European Voice and of POLITICO, he now focuses on healthcare as the Brussels correspondent of APM Europe and the European columnist of Applied Clinical Trials in the USA. He also frequently moderates or animates EU-level conferences and workshops.

Yvonne Stewart is the Head of Brexit Implementation at GSK. Yvonne is a pharmacist with a PhD in Pharmaceutical Sciences and she has more than 15 years of experience with GSK. Prior to her appointment as Head of Brexit Implementation, Yvonne has held a wide variety of roles in Quality and Regulatory across Research & Development, EU Commercial and Global Manufacturing & Supply.Yvonne is a member of the EFPIA Brexit Task Force, the EFPIA Supply Chain Working Group and is the current Chair of the EFPIA Drug Shortages team. In the UK, Yvonne is a member of both the ABPI-BIA Brexit Task force and ABPI Pharmaceutical Quality Expert Network.

Nick is a Policy Advisor for Regulatory Strategy at EFPIA. Nick’s current focus is on the revision of the general pharmaceutcal legislation, regulatory aspects of the Innovative Health Initiative (IHI), and the interface between the drug, device and diagnostics legislative frameworks in the EU. Prior to working at EFPIA, Nick spent 25 years at Pfizer within their Global Regulatory Sciences team. His last role in Pfizer was as Head of Europe and International Regulatory Policy. In this role he was also Co-Chair of EFPIA's Regulatory Strategy Committee. During 2019 Nick was President of TOPRA and Chairman of TOPRA's Board of Directors. Nick has a graduate degree in Genetics/Microbiology and a master’s degree in Information Science

Peter Bachmann is acting as the German NtA Member, a Member of the European Union Network Data Board and the EU IDMP/SPOR Task Force, the HMA WG ‘Better Use of Medicines’/'ePI Task Force', the International Pharmaceutical Regulators Programme (IPRP) Management Committee, and the European Lead of the ICH IGDG (Informal Generic Discussion Group). He has studied biology and chemistry and has a PhD in Pharmaceutical Biology, University of Wuerzburg (Germany). Following a JSPS postdoctoral fellowship at Kyoto University and a DFG Fellowship at the Institute of Food Research Norwich/UK, he has worked at the Institute of Pharmaceutical Biology, TU Braunschweig/Germany, until he joined in 1999 the BfArM, Department of Drug Approval.

Prof. Dr. Klaus CICHUTEK is the President of the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, in Germany. PEI is a senior federal agency reporting to the German Federal Ministry of Health and member of the network of the European regulatory authorities united in the HMA and the EMA. Its research and medicines control activities promote the quality, safety and efficacy of vaccines and biomedicines. Professor Cichutek was been chair of the HMA Management Group (2014 to 2018), member of the WHO ECBS (since 2012), member of the WHO PD-VAC (since 2014), founding member of the German Centre for Infection Research DZIF (since 2010) and between 2011 and 2016 the (alternate) German member of the EMA Management Board.

Niall Dickson, was appointed chief executive of the NHS Confederation in February 2017. He was formerly chief executive and registrar of the General Medical Council from 2010 to 2016 and chief executive of the Kings Fund from 2004 to 2009. Niall was the editor of the Nursing Times from 1983 to 1988, before joining the BBC as health correspondent in 1988 and progressing to the position of social affairs editor for BBC News from 1995 to 2003, broadcasting mainly on the BBC1 Ten O’Clock News and Radio 4’s Today programme. Niall was awarded a CBE in the Queen’s Birthday Honours List in 2017.

Regulatory and R&D professional with extensive experience across a network of industry, government, academic and healthcare system partners and stakeholders. Broad range of expertise in all aspects of medicines and device research and development including evidence generation, licensing, manufacturing, market access and on-market support. Specific areas of expertise include clinical trials, biologics, real world evidence, paediatric drug development, medical devices, pharmacovigilance, CMC and regulatory policy and strategy development.

Mick Foy has been with the MHRA for more than 35 years, he is a member of the MHRA’s Executive Committee and has recently been appointed Director of Delivery . Amongst his responsibilities is to drive initiatives to introduce new and improved services to stakeholders. Mick is SRO for the SafetyConnect and RegulatoryConnect programmes. He also leads MHRA efforts to build PV capabilities in other countries particularly low and middle income countries as part of a global initiative with the Bill and Melinda Gates Foundation.

Gerald Heddell, microbiologist, Chartered Biologist, and a member of the Royal Societies of Biology and Chemistry, joined the MHRA as Director of the Inspection, Enforcement & Standards Division in 2005. Since leaving the NHS, he has worked in a succession of progressively senior roles in manufacturing and QA in the pharmaceutical industry, most recently, in GSK as European Quality and Compliance Director. In the MHRA, Gerald's responsibilities focus on the quality of medicines in the UK and include a comprehensive surveillance, inspection and enforcement programme, the licensing of manufacturers and wholesalers, defective medicines reporting, unlicensed imports, borderline products, medicines testing and the British Pharmacopoeia.

FRSA. Chair: Access Matters, Midstream. Board Member: European Forum for Good Clinical Practice (EFGCP), International Foundation for Integrated Care (IFIC), Health Quality Improvement Forum (HQIP). Having had Rheumatoid Arthritis for nearly 60 years from the age of three, I have a wealth of experience as a user of health services. Since 1990 I have voluntarily represented people with disabilities & chronic conditions locally, nationally & internationally. “The people have the right & duty to participate individually & collectively in the planning & implementation of their healthcare” Alma Ata Declaration – Principle IV, 1978 World Health Organisation

Keith McDonald joined the UK Medicines Control Agency in 1997 and has held positions as pharmaceutical assessor, Unit and Group Manager and was appointed to the position of Deputy Director in 2015. He is responsible for operational delivery of the Licensing Division, including new MAAs, scientific advice, clinical trials applications and parallel imports. The Licensing Division is also responsible for delivery of PIM designations and Scientific Opinions in the UK EAMS and for the operation of the MHRA Innovation Office. He is currently vice chair of the CMDh and the EU regulatory rapporteur for ICH Q11 guideline on development and manufacture of active substances. He is a fellow of the Royal Pharmaceutical Society of Great Britain.

Geraldine Moore is a Pharmacist by training and has more than 16 years’ experience in Regulatory Affairs within the generics industry. She is currently a Senior Registration Manager (EMEA) at Mylan responsible for Regulatory Policy and is a Medicines for Europe Member of the Joint Industries Task Force on Brexit. She has participated as an industry member of the Article 57 Implementation Working Group and is a member of the Medicines for Europe SPOR/ISO IDMP Task Force.

Rita Purcell is the Deputy Chief Executive at the Health Products Regulatory Authority where she has responsibility for international affairs, finance, legal, regulatory affairs, corporate governance and infrastructure. She has lead on a number of international initiatives and is an active participant in the International Coalition of Medicines Regulatory Authorities (ICMRA). Rita is a member of the Board of the European Medicines Agency and has experience on other Boards and audit committees. She read law at University College Dublin and is qualified as a Chartered accountant. She previously worked for Price Waterhouse in Dublin and San Francisco and also has worked in the construction and food industries in the areas of finance

Emlyn leads the policy development team at Cancer Research UK. His team is responsible for developing the charity's position on areas of public policy related to the charity’s goals. This includes the how Government can support a thriving research environment, how cancer services are run - to diagnose patients earlier and provide better access to treatment - and how charity laws should be reformed. His previous roles include policy positions at the Wellcome Trust, The Academy of Medical Sciences, and a secondment to the Office for Life Sciences to support the development of the Life Sciences Industrial Strategy.

Oliver Sude is a German qualified lawyer with fifteen years’ experience in the field of life science. Before joining EUCOPE, he worked with international law firms in Munich, Germany. He has particular expertise in regulatory affairs and intellectual property law as well as in pricing and reimbursement of medicinal products and medical devices.

Chris Walker (MSc RA & BSc Hons), is Head of Regulatory Affairs for Europe, Latin America, Middle East, Africa & Canada for Amgen and Head of the UK R&D sites. Chris believes that a connected healthcare system with an enhanced flow of data will improve European Healthcare. At EFPIA Chris is chair of the Digital Health Working Group & a member of the Innovation & Regulatory Strategy Groups. At Amgen, Chris leads the Region's Regulatory Strategy team ensuring efficient execution of that strategy towards subsequent patient access, engagement with the regulatory agencies and external influence of the regulated environment that Amgen operates within.

Noël Wathion is the Deputy Executive Director of the EMA since February 2016. He is also the Chief of Policy. He joined the Agency in 1996, and has since held several senior managerial positions, including Head of the Post-Authorisation Evaluation of Medicines for Human Use Unit, Head of the Patient Health Protection Unit, and EMA’s Chief Policy Adviser.