PRIORITY WORK AREAS (PWAs) CHAMPIONS
Advanced Therapy Products | |
Champion(s) | Point of Contact |
Health Sciences Authority (HSA), Singapore | Ms Christine Ho Contact: christine_ho@hsa.gov.sg Dr Lee Lee Ong Contact: Ong_Lee_Lee@hsa.gov.sg |
US Food and Drug Administration (FDA), United States | Dr Michelle Limoli Contact: Michelle.Limoli@fda.hhs.gov Ms Judith A. Arcidiacono Contact: Judith.Arcidiacono@fda.hhs.gov |
Biotechnological Innovation Organization (BIO) | Dr Srinivasan N Kellathur |
Biotherapeutic Products | |
Current PWA Management | Point of Contact |
US Food and Drug Administration (FDA), United States | Dr Michelle Limoli Contact: Michelle.Limoli@fda.hhs.gov Ms Judith A. Arcidiacono Contact: Judith.Arcidiacono@fda.hhs.gov |
Biotechnological Innovation Organization (BIO) | Dr Sannie Chong Contact: sannie.chong@merck.com |
Global Supply Chain Integrity | |
Champion(s) | Point of Contact |
US Food and Drug Administration (FDA), United States | Dr Leigh Verbois Contact: Leigh.Verbois@fda.hhs.gov Ms Eunah Kostal Contact: Eunah.Kostal@fda.hhs.gov |
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: tanabe-hirooki@mhlw.go.jp Mr Daisuke Koga Contact: PMDA-RHSC@pmda.go.jp |
Taiwan Food and Drug Administration (TFDA), Chinese Taipei | Mr Chien-Liang Lin Contact: jllin@fda.gov.tw Ms Shirley Pan Contact: pashirle@fda.gov.tw Ms Chia-Ping Liu Contact: meat0901@fda.gov.tw Dr Hsien-Yi Lin Contact: hsienyilin@fda.gov.tw Ms Yi-Ju Lin Contact: maylin25@fda.gov.tw |
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: tanabe-hirooki@mhlw.go.jp Mr Daisuke Koga Contact: PMDA-RHSC@pmda.go.jp |
Ministry of Food and Drug Safety (MFDS), Korea | Mr Jin-Won Seo Contact: bulsasin21@korea.kr Ms Soo-Hyun Nam Contact: soohyun22@korea.kr Ms Da-Yeong Ryoo Contact: rosa7045@korea.kr |
US Food and Drug Administration (FDA), United States | Ms Michelle Noonan Contact: Michelle.Noonan-Smith@fda.hhs.gov Ms Melissa Torres Contact: Melissa.Torres@fda.hhs.gov Ms Erin Cutts Contact: Erin.Cutts@fda.hhs.gov |
Japan Medical Imaging and Radiologial Systems Industries Association (JIRA) | Mr Naoki Morooka Contact: morooka@shimadzu.co.jp |
Advanced Medical Technology Association (AdvaMed), United States | Ms Janet Trunzo Contact: JTrunzo@AdvaMed.org |
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: tanabe-hirooki@mhlw.go.jp Mr Daisuke Koga Contact: PMDA-RHSC@pmda.go.jp |
Food and Drug Administration, Thailand (Thai FDA) | Ms Akanid Wapeewuttikorn Contact: akanid@fda.moph.go.th Ms Charunee Krisanaphan Contact: charunee@fda.moph.go.th Dr Suchart Chongprasert Contact: suchart@fda.moph.go.th |
Pharmacovigilance | |
Champion(s) | Point of Contact |
Ministry of Food and Drug Safety (MFDS), Korea | Ms Mi Ja Park Contact: agamist@korea.kr Mr Dongil Park Contact: dipark@korea.kr |