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Featured Speakers

Speakers

  • Karl  Broich, DrMed

    Karl Broich, DrMed

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

    Prof. Broich is a physician and has been President of the Federal Institute for Drugs and Medical Devices in Bonn since 2014. His current activities in the European network of regulatory authorities are Member of the Management Board of the European Medicines Agency, Chair of the Network Portfolio Advisory Group. He is a member of the HMA Management Group and is currently its Chair. He is also co-chair of the EMA's Darwin EU Advisory Board. His scientific focus is on clinical psychopharmacology, imaging of neurodegenerative diseases and other potential biomarkers and dementia, and clinical trial methodology, among others. Prof. Broich is author and co-author of more than 220 papers (original scientific papers, reviews, book contributions).

  • 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

    • Senior Advisor, Integrated Development
    • Bill and Melinda Gates Foundation, United States

    Dr. Ian Hudson has a leading role on the team in areas that include optimizing clinical studies and strengthening regulatory systems in Africa and other low-resource regions, particularly for malaria, polio, and COVID-19 drugs. Ian was a practicing pediatrician before joining SmithKline Beecham in 1989 to work in research and development. In 2001, he joined the UK government’s MHRA, where he served as director of licensing and then CEO. Ian was the UK delegate to the scientific committee of EMA’s Management Board, CHMP, later becoming its vice chair. He was also an honorary senior lecturer in clinical pharmacology at the University of London and served as chair of the International Coalition of Medicines Regulatory Authorities.

  • Joseph  Scheeren, PharmD

    Joseph Scheeren, PharmD

    • Founder
    • Scheeren HealthCare LLC, United States

    Dr. Scheeren worked in R&D in the Pharmaceutical Industry for over 35 years in the USA, China and Europe. Former Chair of DIA. Currently , he is a Board Member of VacciTech plc. He recently founded a consultancy company ScheerenHeathCare LLC. Since January 2019, he is Adjunct Professor at Peking University for Regulatory Sciences. He was President and CEO of the C-Path Institute from 19-21. Dr. Scheeren serves on the Forum of the NAS, on Advisory Boards at the CIRS, the Regulatory Affairs Track at Yale University, the CoRE in Singapore, the College of Pharmacy at the UA. 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
    • Critical Path Institute, United States

    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

    • VP, GLobal Regulatory Affairs International
    • 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

    • Acting Program Manager, Access to Medicines and Health Products
    • World Health Organization, Denmark

    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.

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