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  • Karl  Broich, DrMed

    Karl Broich, DrMed

    • President
    • Federal Institute for Drugs and Medical Devices (BfArM), Germany

    Physician, MD (certifications in Neurology, Psychiatry, Behavioural Psychotherapy). BfArM in Bonn (Germany): 2000 to 2014 several executive functions, since 08/2014 head (President). Work in several EMA committees; chair of CNS-Working Party. Current research: clinical trials methodology CNS, biomarkers in drug development, Alzheimer’s disease and other neurodegenerative disorders.

  • Kemal Z. Malik

    Kemal Z. Malik

    • Member of the Board of Management
    • Bayer, Germany

  • Michael James Doherty

    Michael James Doherty

    • Head of Product Development
    • Foundation Medicine, United States

    Head of regulatory affairs at Roche and Genentech from 2002 to 2016. Currently head of strategic innovation at Roche and Executive adviser to Foundation Medicine.

  • Ian  Hudson

    Ian Hudson

    • Chief Executive
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

    Dr Ian Hudson became Chief Executive of the MHRA in September 2013. He is a physician who practiced as a paediatrician prior to working in the pharmaceutical industry in clinical research and development. In 2001 he joined the former Medicines Control Agency as its Licencing Division Director. He was also the UK delegate to the Committee for Human Medicinal Products and was its Vice Chair from October 2012 to September 2013.

  • Joseph  Scheeren, PharmD

    Joseph Scheeren, PharmD

    • President and CEO
    • Critical Path Institute (C-Path), United States

    Dr. Scheeren worked in R&D in the Pharmaceutical Industry for over 35 years in the USA, China and Europe. He led the Regulatory Affairs Department in Bayer in the last 15 years. Since January 2019, he is Adjunct Professor at Peking University for Regulatory Sciences in the Department of Clinical Research. In April 2019 he joined C-Path Institute as its President and CEO. Dr. Scheeren serves on Advisory Boards at the Center for Innovation in Regulatory Science, the Regulatory Affairs Track at Yale University, the Center of Regulatory Excellence in Singapore. He is also a foreign member of the Academie Nationale de Pharmacie in France, and a lecturer at Yale University. Dr. Scheeren studied pharmacy at the University of Leiden.

  • Tomas  Salmonson, DrMed, PhD

    Tomas Salmonson, DrMed, PhD

    • Partner
    • Consilium Salmonson and Hemmings, Sweden

    Tomas Salmonson, M.Sc., PhD, brings outstanding experience and expertise from a long career in the regulation of medicines both on a national and European level to his new role. A pharmacist by training, he is currently senior scientific advisor at the Swedish Medical Products Agency in Uppsala, Sweden. He has been a member of the Committee for Medicinal Products for Human Use (CHMP) for more than 12 years. In 2012, Dr Salmonson was elected chair of the CHMP; he was Vice chair of the CHMP from 2007 till 2012. Tomas has been DIA Advisory Council of Europe Member during 1996-2002 and a speaker in over 20 DIA Events.

  • Susan  Forda, PhD

    Susan Forda, PhD

    • Vice President, International Regulatory Affairs
    • Eli Lilly & Company Ltd., United Kingdom

    Sue is a PhD pharmacist. After university she joined SmithKline Beecham Pharmaceuticals followed by Eli Lilly and now is VP for International regulatory affairs. She is currently Chair of the EFPIA “Adaptive Models Priority Working Group”.

  • Sarah  Garner, PhD

    Sarah Garner, PhD

    • Associate Director – Science Policy and Research
    • National Institute for Health and Care Excellence (NICE), United Kingdom

    Professor Sarah Garner is a pharmacist specialising in the interface between Health Technology Assessment (HTA) and regulation. Sarah is the Associate Director for Scientific Policy and Research at NICE and an honorary professor at UCL and Manchester University. She leads Work Packages of the GetReal and ADAPT SMART projects funded by the EU Innovative Medicines Initiative.