Good Regulatory Review Practices

Working Group Chair(s)
Melissa Torres
Food and Drug Administration (FDA)
United States of America
Membership
Regulators
Status
Current

Current consultations

Marketing Review Report Work Instruction

Started
Closing
good-regulatory-review-practices

Participants

Fiona McCormack
Therapeutic Goods Administration (TGA)

Augusto Bencke Geyer
Brazilian Health Regulatory Agency (ANVISA)

Catherine Milley
Health Canada
Maria Carballo
Health Canada

Shiqing Zhang
National Medical Products Administration (NMPA)
Yuxi Yang
Center for Medical Device Evaluation (CMDE)

Aleksandra Rodatus-Gil
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Poland
Mairead Finucane
European Commission
Maria Chiara Orlandi
European Commission
Mario Gabrielli-Cossellu
European Commission
Patrick Murphy
Health Products Regulatory Authority (HPRA), Ireland

Aoyagi Yumiko
Ministry of Health, Labour and Welfare (MHLW)
Dr Koichi Aizawa
Pharmaceuticals and Medical Devices Agency (PMDA)
Dr Madoka Murakami
Pharmaceuticals and Medical Devices Agency (PMDA)
Takehiro Ichikawa
Pharmaceuticals and Medical Devices Agency (PMDA)

Vladimir Antonov
Federal Service for Surveillance in Healthcare (Roszdravnadzor)

Lakshmidevi Balakrishnan
Health Sciences Authority (HSA)

Soonyeong Park
Ministry of Food and Drug Safety (MFDS)

Ms Michal Neukamp
SwissMedic

Dr Kenneth Cavanaugh
Food and Drug Administration (FDA)
Melissa Torres
Food and Drug Administration (FDA)

Deirdre Healy
World Health Organization (WHO)
Irena Prat
World Health Organization (WHO)
Mark Lanigan
World Health Organization (WHO)