David Cockburn is the recently retired Head of Manufacturing and Quality Compliance with the European Medicines Agency (EMA). A Pharmacy graduate, Mr. Cockburn has grounding in the pharmaceutical industry augmented by roles in the authorities at national and EU level. Industry exposure included Regulatory Affairs at GD Searle and in Production at Glaxo Operations, both in the UK. Mr. Cockburn joined the U.K Medicines and Healthcare products Regulatory Agency as a Principal Medicines Inspector and spent 14 years there before moving to the EMA for 15 years and becoming Head of Manufacturing and Quality Compliance. He worked part-time for the last 3 years of his career at EMA and during that time acted as EU’s technical lead in the process towards establishing the EU-USA Mutual Recognition Agreement on GMP Inspections. Since retiring from the European Medicines Agency, Mr. Cockburn has formed associations with a number of organizations promoting training and education on Good Manufacturing Practice and medicines’ quality.
Elizabeth Golberg is currently a Senior Fellow at the Mossavar-Rahmani Center for Business and Government at the Harvard Kennedy School. Her areas of expertise are regulatory policy development and oversight, international regulatory cooperation, external relations, assistance program coordination and management and international trade. She was Director of Better Regulation at the European Commission and a member of the Bureau of the OECD Regulatory Policy Committee. Previously, she managed units in the Secretariat General responsible for external relations and the G7/G20 and for the President’s briefings as well as the unit in the Environment Directorate General responsible for strategic planning and coordination. She held various advisory posts in the European Commission and was coordinator of the European Union’s technical assistance programme in the Czech Republic and Slovakia.
Lawrence O. Gostin
Lawrence O. Gostin is University Professor, Georgetown University’s highest academic rank conferred by the University President. Professor Gostin directs the O’Neill Institute for National and Global Health Law and is the Founding O’Neill Chair in Global Health Law. He is Professor of Medicine at Georgetown University and Professor of Public Health at the Johns Hopkins University. Professor Gostin is the Director of the World Health Organization (WHO) Collaborating Center on National and Global Health Law. He has also been appointed high-level positions at the WHO, such as International Health Regulations (IHR) Roster of Experts and the Expert Advisory Panel on Mental Health. He co-chairs the Lancet Commission on Global Health Law and he is the Legal and Global Health Correspondent for the Journal of the American Medical Association. He is Founding Editor-in-Chief of Laws (an international open access law journal). He also holds multiple international academic professorial appointments, including at Oxford University, the University of Witwatersrand (South Africa), and Melbourne University. In 2016, President Obama appointed Prof. Gostin to the National Cancer Advisory Board, on which he currently serves. He has expertise in areas such as, health law and ethics, global health and global governance, AIDS law and ethics, human rights, privacy and consent. In his previous positions, he served as Associate Dean for Research at Georgetown Law, The WHO Director-General’s Advisory Committee on Reforming the World Health Organization, as well as numerous WHO expert advisory committees, including on the Pandemic Influenza Preparedness Framework, smallpox, genomic sequencing data, and human rights. He served on the WHO/Global Fund Blue Ribbon Expert Panel: The Equitable Access Initiative to develop a global health equity framework. He also served on the drafting team for the G-7 Summit in Tokyo 2016, focusing on global health security and Universal Health Coverage. He was formally the Editor-in-Chief of the Journal of Law, Medicine & Ethics. Professor Gostin served on the Governing Board of Directors of the Consortium of Universities for Global Health. He is a member of the National Academy of Medicine.
Gavin Huntley-Fenner is a human factors and safety consultant at Huntley-Fenner Advisors. His areas of expertise are risk management and communication. He has a unique problem-solving skill set and communication style developed over 20 years as a researcher, author, educator and business consultant. He regularly provides consumer product hazard analyses and has served as an expert witness for matters relating to risk perception, instruction manuals, warnings, labeling, safety and human development, human reaction time and decision-making. Dr. Huntley-Fenner has been invited to speak at national and international scientific and nonscientific gatherings on topics ranging from basic and applied research to forensic consulting and to education. He is a former member of the United States Food and Drug Administration Risk Communication Advisory Committee.
Professor Barbara Koremenos received her Ph.D. from the University of Chicago and is now Professor of Political Science at the University of Michigan. She received a National Science Foundation CAREER Award for her research -- the first such winner to study international relations and law. She has given seminars in the United States, Canada, Denmark, France, Germany, Greece, Italy, Japan, Latvia, South Korea, Spain, Sweden, and Switzerland. Her award-winning book, The Continent of International Law: Explaining Agreement Design (Cambridge University Press 2016), focuses on how international law can be structured to make international cooperation most successful.
Murray Lumpkin is Deputy Director, Global Health/Integrated Development, and Lead for Global Regulatory Systems Initiatives at the Bill and Melinda Gates Foundation. The Global Regulatory Systems Initiatives are focused on working with partners such as WHO (Geneva), PAHO, AFRO, regulatory regionalization initiatives, and NRAs in all parts of the world, to make more efficient and effective (without sacrificing product quality, efficacy, or safety) the regulatory processes through which health care products must pass to be developed, be eligible for procurement, and be legally marketed in low- and middle-income countries on which the Foundation focuses. Before joining the Bill and Melinda Gates Foundation, Dr. Lumpkin was the Director, Division of Anti-infective Drug Products (CDER); Deputy Center Director for Review Management (CDER); and Deputy Commissioner for International Programs at the US Food and Drug Administration, serving at the US FDA from 1989 to 2014.
Lembit Rägo is the Secretary-General of the Council for International Organizations of Medical Sciences. His research interests include international drug regulation, pharmaceutical policy, and regulatory cooperation. When he was previously working at the World Health Organization (WHO), he worked on activities related to International Non-proprietary Names (INNs), quality assurance, pharmacovigilance, regulatory support, fighting falsified medicines and prequalification of medicines. His previous positions include Professor of Clinical Pharmacology at Tartu University, founder and first Director General of the Estonian Drug Regulatory Authority, State Agency of Medicines, Coordinator of Quality Assurance and Safety: Medicines (QSM) team at the WHO, and Head of WHO’s Regulation of Medicines and Other Health Technologies unit.