SUMMIT HOST
Professor Anthony (Tony) Lawler, TGA
Professor Anthony (Tony) Lawler is the Deputy Secretary of Health Products Regulation, Australian Department of Health and Aged Care. As Deputy Secretary, Tony is the head of Australia’s Therapeutic Goods Administration (TGA), managing the regulation of medicines, biologics, and medical devices. The TGA works to safeguard and enhance the health of all Australians through effective, timely and risk-proportionate regulation of therapeutic goods. Tony’s responsibilities under Health Products Regulation also extends to the regulation of gene technology and industrial chemicals through the Office of Gene Technology Regulator and the Australian Industrial Chemical Introduction Scheme, and control of drug import, export and production, through the Office of Drug Control. Tony has dual medical specialist qualifications in Emergency Medicine and Medical Administration. He is also a Board member of the Australian Commission on Safety and Quality in Health Care, and a Professor in Health Services at the University of Tasmania.
ICMRA CHAIR
Ms Emer Cooke, EMA
Emer Cooke is the Executive Director of the European Medicines Agency, based in Amsterdam. She also holds the role of Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA). Previously, she was the Director responsible for all medical product-related regulatory activities at the World Health Organization in Geneva between November 2016 and November 2020. Ms. Cooke is a pharmacist with Masters degrees in Science and Business Administration from Trinity College Dublin. She has over 30 years’ experience in international regulatory affairs and held management positions at the European Medicines Agency as Head of Inspections and Head of International Affairs respectively from 2002 until 2016. From September 1998 to July 2002, she worked in the Pharmaceuticals unit of the European Commission, where intra-alia, she was responsible for international collaboration, EU enlargement and the orphan medicines regulation.