PRIORITY WORK AREAS (PWAs) CHAMPIONS
Advanced Therapy Products | |
Champion(s) | Point of Contact |
Health Sciences Authority (HSA), Singapore | Ms Christine Ho Contact: [email protected] Dr Lee Lee Ong Contact: [email protected] |
US Food and Drug Administration (FDA), United States | Dr Michelle Limoli Contact: [email protected] Ms Judith A. Arcidiacono Contact: [email protected] |
Biotechnological Innovation Organization (BIO) | Dr Srinivasan N Kellathur Contact: [email protected] |
Biotherapeutic Products | |
Current PWA Management | Point of Contact |
US Food and Drug Administration (FDA), United States | Dr Michelle Limoli Contact: [email protected] Ms Judith A. Arcidiacono Contact: [email protected] |
Biotechnological Innovation Organization (BIO) | Dr Sannie Chong Contact: [email protected] |
Global Supply Chain Integrity | |
Champion(s) | Point of Contact |
US Food and Drug Administration (FDA), United States | Dr Leigh Verbois Contact: [email protected] Ms Eunah Kostal Contact: [email protected] |
Good Registration Management | |
Champion(s) | Point of Contact |
Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan | Mr Hirooki Tanabe Contact: [email protected] Mr Daisuke Koga Contact: [email protected] |
Taiwan Food and Drug Administration (TFDA), Chinese Taipei | Mr Chien-Liang Lin Contact: [email protected] Ms Shirley Pan Contact: [email protected] Ms Chia-Ping Liu Contact: [email protected] Dr Hsien-Yi Lin Contact: [email protected] Ms Yi-Ju Lin Contact: [email protected] |
Medical Devices | |
Champion(s) | Point of Contact |
Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan | Mr Hirooki Tanabe Contact: [email protected] Mr Daisuke Koga Contact: [email protected] |
Ministry of Food and Drug Safety (MFDS), Korea | Mr Jin-Won Seo Contact: [email protected] Ms Soo-Hyun Nam Contact: [email protected] Ms Da-Yeong Ryoo Contact: [email protected] |
US Food and Drug Administration (FDA), United States | Ms Michelle Noonan Contact: [email protected] Ms Melissa Torres Contact: [email protected] Ms Erin Cutts Contact: [email protected] |
Japan Medical Imaging and Radiologial Systems Industries Association (JIRA) | Mr Naoki Morooka Contact: [email protected] |
Advanced Medical Technology Association (AdvaMed), United States | Ms Janet Trunzo Contact: [email protected] |
Multi-Regional Clinical Trials & Good Clinical Practice Inspection | |
Champion(s) | Point of Contact |
Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan | Mr Hirooki Tanabe Contact: [email protected] Mr Daisuke Koga Contact: [email protected] |
Food and Drug Administration, Thailand (Thai FDA) | Ms Akanid Wapeewuttikorn Contact: [email protected] Ms Charunee Krisanaphan Contact: [email protected] Dr Suchart Chongprasert Contact: [email protected] |
Pharmacovigilance | |
Champion(s) | Point of Contact |
Ministry of Food and Drug Safety (MFDS), Korea | Ms Mi Ja Park Contact: [email protected] Mr Dongil Park Contact: [email protected] |