PRIORITY WORK AREAS (PWAs) CHAMPIONS 

Advanced Therapy Products

Champion(s)

Point of Contact

Health Sciences Authority (HSA), Singapore

Dr Srinivasan Kellathur

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 Sannie Chong

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 Chyn-Liang Huang

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

Ms Min-Jung Kim

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 In Sun Lee

Contact: [email protected]

Ms Yeoreum Lee

Contact: [email protected]