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DIA Brexit Summit | Ensuring Continuity for Patients and Business


Speakers

  • Steve  Bates

    Steve Bates

    • Chief Executive Officer
    • BioIndustry Association, United Kingdom

    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, MA

    Elizabeth Kuiper, MA

    • Executive Director, Public Affairs
    • European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium

    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  Morrison, PhD

    Alan Morrison, PhD

    • Vice President Regulatory Affairs Intl
    • Merck Sharp & Dohme, United Kingdom

    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

    Aimad Torqui

    • Executive Director Global Regulatory Policy
    • MSD, Netherlands

    Aimad Torqui is Director of Global Regulatory Policy at MSD. Previous employment. He has worked with governments, regulators, trade bodies and other external stakeholders to shape robust science-based regulatory policy.

  • Virginia  Acha, PhD, MSc

    Virginia Acha, PhD, MSc

    • Global Lead, Global Regulatory Policy
    • United Kingdom

    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 recently joined MSD to lead regulatory policy efforts for innovation that will lead to better treatment for patients in Europe, the Middle East, Africa and Asia. In particular, she is supporting work on science policy, regulatory innovation and integrated evidence generation. Before joining MSD, Ginny was the senior spokesman for the industry in the UK for research, medical and innovation policy. She was responsible for ABPI’s work on BREXIT for the life sciences sector. Previously, Ginny worked for Amgen and Pfizer.

  • Vicki  Edwards

    Vicki Edwards

    • Vice President, Pharmacovigilance Excellence and International QPPV
    • AbbVie, Inc., United Kingdom

    Qualified as a pharmacist in 1981 and started her career in hospital pharmacy. In 1983 she specialised in Drug Information Services and moved to Kuwait to set up and run the first National Drug Information Centre. On her return to the UK, Vicki spent the next four years in community pharmacy. In 1996 Vicki joined GlaxoWellcome and started her career in pharmacovigilance. In 2002 she moved to AstraZeneca UK Ltd as the Drug Safety Manager moving on to become Head of Drug Safety & Medical Information. Vicki joined Abbott in 2005 as European Qualified Person for Pharmacovigilance (EU QPPV). In 2013 moved to AbbVie as EU QPPV and Head of Affiliate Safety Excellence (ASE) and is now VP, Pharmacovigilance Excellence and I-QPPV.

  • Zamshed  Harun

    Zamshed Harun

    • CEO
    • Makaris Strategies, Switzerland

    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

    Peter O'Donnell

    • Journalist
    • Belgium

    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, PhD

    Yvonne Stewart, PhD

    • Head of Brexit Implementation, Office of the CEO and CFO
    • GSK, United Kingdom

    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  Sykes, MS

    Nick Sykes, MS

    • Senior Director, Global Regulatory Affairs
    • Pfizer, Inc., United Kingdom

    Currently working in Europe and International regulatory policy and strategy group in Pfizer. Been working for Pfizer since 1998. My main focus - lead a small team providing regulatory policy and strategy to Pfizer organisation particularly regulation of clinical trials. Previous employment includes SmithKline Beecham, Scrip and Cambridge Antibody Technology

  • Peter  Bachmann

    Peter Bachmann

    • Deputy-Head, European Union and International Affairs
    • Federal Institute for Drugs and Medical Devices (BfArM), Germany

    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.

  • Klaus  Cichutek, PhD

    Klaus Cichutek, PhD

    • Director
    • Paul-Ehrlich-Institut, Germany

    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

    Niall Dickson

    • Chief Executive
    • NHS Confederation, United Kingdom

    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.

  • Emma  Du Four, MBA

    Emma Du Four, MBA

    • Head of International Regulatory Policy
    • Abbvie, United Kingdom

    Emma Du Four has extensive global experience in the biopharmaceutical industry, encompassing product development, clinical trials, real world evidence, paediatric medicines, biotherapeutics, devices, pharmacovigilance, policy and strategy development. Emma currently serves as Head of International Regulatory Policy at AbbVie and she is Chair of the EFPIA Regulatory Affairs & Operations working group. Emma holds an Honours degree in BioChemistry, an MBA and is a Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA)

  • Mick  Foy

    Mick Foy

    • Head of Pharmacovigilance Strategy
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

    Mick Foy has been with the MHRA for more than 30 years, he is a member of the MHRA’s Senior Leadership team as since 2019 Head of PV Strategy. Amongst his responsibilities is to lead 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 and WHO. Mick continues to have oversight of the operation of the UK’s Yellow Card Scheme and the MHRA’s signal detection systems. He is currently leading the MHRA’s transformation of vigilance systems with a remit to develop common IT and methodologies for medicines and devices. Mick is Chair of the MedDRA Management Committee, and a member of the Uppsala Monitoring Centre Board.

  • Gerald W. Heddell

    Gerald W. Heddell

    • Director, Inspection Enforcement & Standards Division
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

    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.

  • Robert Andrew Johnstone

    Robert Andrew Johnstone

    • Patient Representative
    • The International Foundation for Integrated Care (IFIC), United Kingdom

    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, MSc

    Keith McDonald, MSc

    • Deputy Director, Licensing Division
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

    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

    Geraldine Moore

    • Senior Registration Manager, Central Regulatory Affairs (EMEA)
    • Mylan, United Kingdom

    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, LLM

    Rita Purcell, LLM

    • Deputy Chief Executive
    • Health Products Regulatory Authority (HPRA), Ireland

    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 leads on a number of international initiatives including the HPRA respponse to Brexit and actively participates in the International Coalition of Medicines Regulatory Authorities (ICMRA). Rita is the alternate member of the EMA Management Board and previously worked for Price Waterhouse in Dublin and San Francisco. She is a chartered accountant and has a law degree from University College Dublin.

  • Emlyn   Samuel

    Emlyn Samuel

    • Senior Policy Manager
    • Cancer Research UK, United Kingdom

    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.

  • Paul  Sexton

    Paul Sexton

    • GMP Manager
    • Health Products Regulatory Authority (HPRA), Ireland

  • Oliver  Sude, PhD

    Oliver Sude, PhD

    • Legal Counsel, EU Affairs
    • European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Belgium

    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

    Chris Walker, MSc

    • Vice President, Head of Regulatory Affairs for Europe, Latin America, Middle Eas
    • Amgen, United Kingdom

    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, RPh

    Noël Wathion, RPh

    • Deputy Executive Director
    • European Medicines Agency, Netherlands

    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.

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