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Advisory Board Members

Advisory Board Members: Category, Name, Position, Organization
Category Name Position Organization
Official Position Sun Hee Lee Director / Director General APEC Harmonization Center / National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety (MFDS)
Erika Elvander Chair Life Sciences Innovation Forum (LSIF) Planning Group
Michelle Limoli Co-Chair / International Planning Director Regulatory Harmonization Steering Committee (RHSC) / International Programs Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA)
Nakashima Nobumasa Co-Chair / Associate Executive Director Regulatory Harmonization Steering Committee (RHSC) / Pharmaceutical Affairs, Ministry of Health, Labour and Welfare (MHLW)
He Li Vice Chair / Division Director Regulatory Harmonization Steering Committee (RHSC) / Bilateral Cooperation, China Food and Drug Administration (CFDA)
International Organization Janis Bernat Director Biotherapeutics & Scientific Affairs, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
Mike Ward - World Health Organization (WHO)
Lindsay Tao Vice Chair / Corporate Director Asian Harmonization Working Party (AHWP) / Global Health Policy, Johnson&Johnson
Government Cheng Leng Chan Group Director Health Sciences Authority (HSA)
Christian Jesus Garnica Vergara Manager International Affairs of Chemicals, Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)
Rocio Delgado Montero International Coordinator - Technical Assesor of General Direction Direccion General de Medicamentos, Insumos y Drogas (DIGEMID)
Tomas Salmonson Chair / Senior Scientific Advisor Committee for Medical Products for Human Use (CHMP) / Swedish Medical Products Agency
Chang-Soo Ryu Director Mutilateral Economic Affairs, Ministry of Foreign Affairs
Industry Association Jerry Stewart Deputy Vice President Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Janet Trunzo Senior Executive Vice President Advanced Medical Technology Association (AdvaMed)
Caroline Mendy Manager Regulatory Policy and Technical Standards Committee (RPTS)
Naoki Morooka Vice Division - Chairman Japan Medical Imaging and Radiological Systems Industries Associations (JIRA)
Hee Mok Won Chairman Korea Pharmaceutical Manufacturers and Bio-pharma Association (KPBMA)
Kazuharu Matsuoka Director Japan Pharmaceutical Manufacturers Association (JPMA)
Industry Romi Singh Head of Regulatory Affairs Asia Worldwide Safety and Regulatory - Innovative, Pfizer, Inc
Wassim Nashabeh Global Head Regulatory Policy, Genentech (Roche Group)
Thean Soo Lo Director / AP Lead Global Policy Intelligence, Janssen (Johnson Johnson)
Academia Kennard D. Brown Executive Vice Chancellor / Chief Operations Officer Office of the Executive Vice Chancellor, University of Tennessee Health Science Center
Sung-Joo Hwang Professor College of Pharmacy, Yonsei University
Others Neil McAuslane Director Centre for Innovation in Regulatory Science (CIRA)
Florence Houn Vice President / Co-Chair Regulatory Policy and Strategy, Celgene Co. / FDA Alumni Association
Justina Molzon - FDA Alumni Association
Jeffrey Gren Board Member Alliance for Safe Online Pharmacies (ASOP)
Mark Paxton Co-Founder SureMed Technologies, Inc
Advisory Board Members: Category, Name, Position, Organization
Category Name Position Organization
APEC Regulatory Harmonization Priority Work Areas (PWAs) Supply Chain Security Ilisa Bernstein Deputy Director CDER, Compliance, Office of Drug Security, Integrity & Response, U.S. Food and Drug Administration (FDA)
Biotherapeutics Yookyoung Lee Senior Scientist / Reviewer Biopharmaceutical Policy Department, Ministry of Food and Drug Safety (MFDS)
Pharmacovigilance Eun Hee Moon Director Pharmaceutical Safety Evaluation Division, Ministry of Food and Drug Safety (MFDS)
Medical Device Vigilance Hyeon Ho Kim Deputy Director Medical Device Safety Bureau, Medical Device Safety Bureau, Ministry of Food and Drug Safety (MFDS)
Multi-Regional Clinical Trials (MRCT) Takanashi Fumihito Deputy Director International Regulatory Affairs, Ministry of Health, Labour and Welfare
Good Clinical Practices (GCP) Inspection Charunee Krisanaphan Senior Professional level International Coordinator System and Policy Development Division, Thai FDA
Good Registration Management (GRM) Chao-Yi Wang Director Division of Medicinal Products, Chinese Taipei Food and Drug Administration (TFDA)
Advance Therapy (CTT) Srinivasan Kellathur Head Advanced Therapy Product Unit, Pre-Marketing, Health Products Regulation Group, Health Sciences Authority (HSA)
Advisory Board Members: Category, Name, Position, Organization
Category Name Position Organization
APEC Secretariat Johnny Lin Hung-hsun Program Director APEC Secretariat
Advisory Board Members: Category, Name, Position, Organization
Category Name Position Organization
RHSC Secretariat Josephine Wong Centre of Regulatory Excellence (CoRE), Duke-NUS
Advisory Board Members: Category, Name, Position, Organization
Category Name Position Organization
LSIF Secretariat Patricia Wu Managing Director C & M International
Michael Schmitz Consultant C & M International
Eric Obscherning Consultant C & M International