Dr June Raine, MHRA

Dr June Raine DBE is CEO of the Medicines and Healthcare products Regulatory Agency. She trained in medicine in Oxford after completing a Master’s degree by research in Pharmacology. Her interest in drug safety led to a career in medicines regulation which has spanned a number of roles in assessment, management and strategic development within the UK national authority. She was elected in 2012 as the first chair of the European Pharmacovigilance Risk Assessment Committee, and is also co-Chair of the WHO Advisory Committee on Safety of Medicinal Products. Her special interests are in monitoring the outcomes of regulatory action, risk communication and patient involvement in the regulatory process.

Dr Yasuhiro Fujiwara, PMDA

Dr Yasuhiro Fujiwara has taken his position as Chief Executive of Pharmaceuticals and Medical Devices Agency (PMDA) since April 1, 2019. He has been re-elected Co-chair of the International Coalition of Medicines Regulatory Authorities (ICMRA) from 1st October 2022. Dr. Yasuhiro Fujiwara was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and Deputy Director of the Hospital, National Cancer Center Hospital. He is a medical oncologist, specializing in breast cancer. Before joining National Cancer Center Hospital, he was Deputy Director of the Evaluation Division II of the Pharmaceuticals and Medical Devices Evaluation Center of the National Institute of Health Sciences (PMDEC, which later merged with other organizations to form PMDA) of the Ministry of Health and Welfare and Labor between 1997 - 2002, making his current position as Chief Executive his second appointment. Between Jan 2011 to Feb 2013, he was Deputy Secretary General of Office of Medical Innovation, Cabinet Secretariat of Japan, and led health policy issues regarding life science. Dr Fujiwara has authored or co-authored over 280 original articles in peer-reviewed journals including Nature Reviews Drug Discovery, Lancet Oncology, Journal of Clinical Oncology, Annals of Oncology. He is an active member of American Society of Clinical Oncology (between 2003 and 2006, he was International Affairs Committee’s member), and Board Member of Japanese Society of Medical Oncology (JSMO) (He was the President of 2019 JSMO annual meeting, held in Kyoto). He is on the Editorial Board of Cancer Chemotherapy and Pharmacology; Cancer Science; Investigation New Drugs; Asian-Pacific Journal of Clinical Oncology; Japanese Journal of Clinical Oncology.

CAPSTONE SPEAKER

Professor Melissa Little, AC

Professor Melissa Little, AC, BSc (Hons I), PhD, GAICD, FAAHMS, FAAS, is CEO of the Novo Nordisk Foundation Centre for Stem Cell Medicine (reNEW), Executive Director of reNEW Copenhagen, Chief Scientist at the Murdoch Children’s Research Institute, and leader of the Kidney Regeneration Laboratory, Melbourne, Australia where she holds an NHMRC Senior Principal Research Fellow. Melissa is the Immediate Past President of the International Society for Stem Cell Research and holds an honorary position as Professor in the Department of Pediatrics, University of Melbourne.

REGULATORY SPEAKERS

Dr Ian Rees, MHRA

Ian joined the MHRA as a GMP inspector in 2001, before this he was an inspector with the Veterinary Medicines Directorate and before that worked for a start up biopharmaceutical firm during which time it was authorised by US FDA and MHRA. In 2004, Ian became a manager responsible for the London based team of GMP inspectors, he was promoted to Expert GMP Inspector in 2006 and Unit Manager Inspectorate Strategy and Innovation in 2014 managing a team of Expert Inspectors. Between 2008 and 2015, Ian was MHRA’s representative on the EMA’s GMDP Inspectors Working Group. Ian was also one of the MHRA’s representative at EU Blood Authority Meetings. Ian was part of the MHRA’s Innovation Office team and UK cross regulatory ‘One Stop Shop’ providing regulatory advice and guidance to organisations developing innovative processes or novel manufacturing processes. Ian led MHRA’s work in developing the new regulatory framework for distributed and point of care manufacture until he retired from MHRA in March 2023.

Dr Yasuhiro Fujiwara, PMDA

Turki Bin Hammad, SFDA

Turki Bin Hammad is the team lead of the methodology and biostatistics at the Efficacy and safety department in the Saudi Food and Drug Authority. He has a background in Pharmacy and completed a Master of Science degree in Epidemiology at the London School of Hygiene and Tropical Medicine. He has been with the SFDA since 2017 as a reviewer of clinical development programs pertaining to new drug applications. His interest is in improving the methodology of estimating causal effects when using non-randomized data and transportability of causal effects from randomized controlled trials to target populations.

Dr Tony Gill, TGA

Dr Tony Gill is a public health physician who is a Principal Medical Adviser in the Therapeutic Goods Administration (TGA) and heads up the Advanced Biological and Therapies Section in the Prescription Medicines Authorisation Branch. In this role he heads up a section involved in the clinical evaluation and market authorisation decision making for gene therapies and cell therapies as well as being involved in developing policy on emerging advanced therapies. He commenced work at the TGA in February 2010 following 25 years in the Australian Army and has filled various roles including acting Chief Medical Adviser of the TGA and Senior Medical Adviser roles until before moving to his current position in February 2022. In the TGA he has been involved in the regulation of unapproved therapeutic goods, the clinical evaluation of medicines, biologicals and medical devices, and the scheduling of medicines. As well Dr Gill was the lead for the introduction of TGA’s medicine shortages section and its medicinal cannabis section. Dr Gill is the current President-elect of AFPHM and is the past Chair of both the Faculty Training Committee and the Faculty Education Committee. He is Chair of the Faculty Policy and Advocacy Committee.

Professor Mojisola Adeyeye, NAFDAC

Prof Moji Adeyeye is the Director General of National Agency for Food and Drug Administration and Control (NAFDAC) where she has added strong governance structure and regulatory strengthening to NAFDAC through disciplined and motivating workforce, updating of regulations and guidelines, strengthening the local pharmaceutical companies through international best practices, and encouraging local production. She has brought NAFDAC from insolvency to solvency. She refocused the Agency through Quality Management System approach and WHO Global Benchmarking to be Standard Operating Procedure-driven organization that has embraced international standards and best practices. This has resulted in attainment of ISO 9001-2015 in 2019, WHO Maturity Level 3 (ISO 9004) in 2022 (a recognition as a well-functioning Agency in many regulatory functions), and Prequalification of Lagos Central Drug Control Laboratory in 2023. She changed the culture of NAFDAC to Customer-focused and Agency-minded establishment in order to safeguard the health of the nation. The Director General is keenly involved in the Lot Release, Post-Approval Safety Monitoring, and Traceability of COVID-19 vaccines, that is focused on visibility of COVID-19 Vaccines Supply Chain using GS1-driven Technology nationally and continentally. She has initiated research collaboration with several institutions as a means of increasing staff competency and improving regulatory research.

Prof Adeyeye graduated from University of Nigeria, Nsukka, Nigeria with a B. Pharm degree in 1976. She obtained her PhD from the University of Georgia, Athens, GA, in Industrial Pharmacy, in 1988. Prior to assuming the position of Director General of NAFDAC, she was a Professor of Pharmaceutical Manufacturing and Drug Evaluation for thirty years in the USA She has mentored over 15 PhD and M.S candidates co-advised 18 graduate students as research committee member.