DIA Brexit Summit | Ensuring Continuity for Patients and Business
- 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
- 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.
- Vice President, RAI
- Merck Sharpe & Dohme, United Kingdom
Aimad Torqui, MSc
- Director, Global Regulatory Policy
- MSD, Netherlands
Aimad Torqui is Director of Global Regulatory Policy at MSD. Previous employment includes Medicines Evaluation Board and Novartis Vaccines. He has worked with governments, regulators, trade bodies and other external stakeholders to shape robust science-based regulatory policy.
Virginia Lee Acha, PhD, MSc
- Executive Director, Global Regulatory Policy
- MSD, United Kingdom
Virginia (Ginny) has worked in private sector and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined ABPI in 2015 to lead policy for research, medical and innovation to deliver better treatment for patients. Ginny is the senior ABPI lead for the association’s work on BREXIT. Before ABPI, Ginny was a Director for Regulatory Policy at Amgen and a Director for International Policy at Pfizer.
Vicki Edwards, RPh
- Vice President, Pharmacovigilance Excellence and QPPV
- AbbVie, Inc., United Kingdom
Vicki Edwards qualified as a pharmacist and spent time in hospital pharmacy and community pharmacy before going GlaxoWellcome in 1995 to begin her career in pharmacovigilance .She moved to AstraZeneca in 2000 as head of Safety & Medical Information at the UK affiliate and moved to Abbott as QPPV in 2005. When Abbott split into Abbott and AbbVie in 2013 Vicki became AbbVie QPPV and Head of Affiliate Vigilance Excellence. Today Vicki is Vice President, Pharmacovigilance Excellence and QPPV.
- Head of European Regulatory and R&D Policy
- Amgen (Europe) GmbH, 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 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
- 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
- Senior Director, Worldwide Safety & Regulatory
- Pfizer Ltd., United Kingdom
Currently working in Europe and International regulatory policy and strategy group in Pfizer. Been working for Pfizer for 17 years. My main focus - lead a small team providing regulatory policy and strategy to Pfizer organisation. Previous employment includes SmithKline Beecham, Scrip and Cambridge Antibody Technology
- Deputy-Head, European Union and International Affairs
- Federal Institute for Drugs and Medical Devices (BfArM), Germany
Following a Japan Society for Promotion of Science Postdoctoral Fellowship at Kyoto University (Japan), and a German Research Foundation Fellowship at the Institute of Food Research in Norwich (UK), Dr. Bachmann worked at the Institute of Pharmaceutical Biology at the Technical University Braunschweig (Germany), until joining the German Federal Institute for Drugs and Medical Devices (BfArM) Department of Drug Approval in 1999. He currently serves as Head of the ‘International Liaison Office’ and as Deputy-Head of the Cooperate Department ‘European Union and International Affairs’. Dr. Bachmann studied biology and chemistry and has a Doctorate of Natural Sciences (Pharmaceutical Biology) from the University of Wuerzburg (Germany).
Klaus Cichutek, PhD
- 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 has been chair of the HMA Management Group (since 2014), 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.
- 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
- Head of International Regulatory Policy & Intelligence
- AbbVie Inc, United Kingdom
Emma Du Four has extensive experience in the biopharmaceutical industry encompassing product development, biotherapeutics, devices, pharmacovigilance, policy and strategy development. Emma currently serves as AbbVie’s Senior Director for the company’s Regulatory Policy and Intelligence division where she is responsible for providing strategic guidance and leadership on key regulatory policy issues. She is also a Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA)
- Head of Pharmacovigilance Strategy, Vigilance Intelligence and Research Group
- MHRA, United Kingdom
Mick has been with the MHRA’s Vigilance Intelligence and Research Group for 11 years. Amongst his responsibilities is the operation of the UK’s Yellow Card Scheme and the signal detection system. He is responsible for two major projects to improve drug safety. Firstly a Gates Foundation funded project to build PV capacity in low and middle income countries and the IMI funded WEB-RADR project to deliver mobile Apps for reporting ADRs and to utilise social media for drug safety purposes.
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
- Patient Advocate; Board Member
- European Forum for Good Clinical Practice (EFGCP), 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
- 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.
- 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
- 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 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
- 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.
- GMP Manager
- Health Products Regulatory Authority (HPRA), Ireland
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
- Vice President, European Head of Regulatory Affairs
- Amgen Ltd, United Kingdom
Chris Walker (MSc RA & BSc Hons), is Head of Regulatory Affairs for Europe for Amgen and Head of the UK R&D sites.. Chris is chair of the Digital Health Taskforce at EFPIA, a member of the Innovation BSC & Regulatory Strategy Groups. Chris leads the regulatory strategy team for Amgen’s portfolio across the Europe region, ensures efficient execution of that strategy, engagement with the regulatory agencies in Europe and external influence of the regulated environment that Amgen operates within.
Noël Wathion, RPh
- Deputy Executive Director
- European Medicines Agency, European Union, United Kingdom
Noël Wathion is the Deputy Executive Director of the EMA since February 2016. He is also the Chief of Policy and Chair of the ORP Task Force. 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. He started his career in a retail pharmacy. He was later appointed to the Belgian Pharmaceutical Inspectorate in Brussels as a Chief Inspector, acting as the Secretary of the Belgian Medicines Commission. He is a former Belgian Member of the CPMP and CVMP, and Belgian representative on the Pharmaceutical Committee, Standing Committee and NTA working group.