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2011 Workshops > Asia Regulatory Conference

Speakers

Day1

Justina A. Molzon (Dr.) 

  • Justina A. Molzon (Dr.)
    • Associate Director
    • International Programs, Center for Drug Evaluation and Research
    • US FDA
  • Day 1 > Session 1-1

Mike Ward (Mr.) 

  • Mike Ward (Mr.)
    • Manager
    • International Program Division, Health Products and Food Branch
    • Health Canada, Canada
  • Day 1 > Session 1-2

Shinobu Uzu (Mr.) 

  • Shinobu Uzu (Mr.)
    • Director
    • International Planning
    • Ministry of Health, MHLW, Japan
  • Day 1 > Session 1-3

Sun Hee Lee (Dr.) 

  • Sun Hee Lee (Dr.)
    • Director
    • Drug Evaluation Department
    • KFDA, Republic of Korea
  • Day 1 > Session 1-4

Mike Ward (Mr.) 

  • Mike Ward (Mr.)
    • Manager
    • International Program Division, Health Products and Food Branch
    • Health Canada, Canada
  • Day 1 > Session 2-1

Kui Lea Park (Dr.) 

  • Kui Lea Park (Dr.)
    • Director
    • Center for Drug Development Assistance
    • KFDA, Republic of Korea
  • Day 1 > Session 2-2

Yuppadee Javroongrit (Dr.) 

  • Yuppadee Javroongrit (Dr.)
    • Assistant Director & Head of International Affairs & IND Section Drug Control Division, FDA, Ministry of Public Health, Thailand
  • Day 1 > Session 2-3

Hee Young Park (Ms.) 

  • Hee Young Park (Ms.)
    • KFDA, Republic of Korea
  • Day 1 > Session 2-4-1

Shinobu Uzu (Ms.) 

  • Shinobu Uzu (Ms.)
    • Director
    • International Planning
    • Ministry of Health, MHLW, Japan
  • Day 1 > Session 2-4-2

Thomas Kubic (Mr.) 

  • Thomas Kubic (Mr.)
    • President and CEO of the Pharmaceutical Security Institute
    • USA
  • Day 1 > Parallel Tracks > Track 1-1

Eishah A. Rahman (Dato’) 

  • Eishah A. Rahman (Dato’)
    • Senior Director
    • Pharmaceutical Services Division
    • Ministry of Health, Malaysia
  • Day 1 > Parallel Tracks > Track 1-2

Ruth Lee Choo Ai (Ms.) 

  • Ruth Lee Choo Ai (Ms.)
    • Acting Director
    • Enforcement Branch, Health Products Regulation Group
    • HSA, Singapore
  • Day 1 > Parallel Tracks > Track 1-3

Geroges France (Dr.) 

  • Geroges France (Dr.)
    • Vice President
    • IAQC, Pfizer, UK
  • Day 1 > Parallel Tracks > Track 2-1

Moheb Nasr (Dr.) 

  • Moheb Nasr (Dr.)
    • Director
    • Office of New Drug Quality, CDER
    • FDA, USA
  • Day 1 > Parallel Tracks > Track 2-3

Yukio Hiyama (Dr.) 

  • Yukio Hiyama (Dr.)
    • Chief
    • Third Section, Division of Drugs, NIHS
    • MHLW, Japan
  • Day 1 > Parallel Tracks > Track 2-4

Jalene Poh (Ms.) 

  • Jalene Poh (Ms.)
    • Regulatory Consultant
    • Pharmaceuticals & Biologics Branch, Pre-Marketing Division
    • Health Products Regulatory Group, HSA, Singapore
  • Day 1 > Parallel Tracks > Track 3-1

Lembit Rago (Dr.) 

  • Lembit Rago (Dr.)
    • Coordinator
    • QSM, Essential Medicines Pharmaceutical Policies Department
    • WHO, Switzerland
  • Day 1 > Parallel Tracks > Track 3-2

Alistair Davidson (Mr.) 

  • Alistair Davidson (Mr.)
    • Senior Director
    • Regulatory Affairs, Asia-Pacific, PPD, UK
  • Day 1 > Parallel Tracks > Track 3-3

Day2

Ken Kobayashi (Dr.)

  • Ken Kobayashi (Dr.)
    • Head of Clinical Science Oncology
    • Johnson & Johnson, Japan
  • Day 2 > Session 1-1

Ajmeer Ramkishan (Dr.)

  • Ajmeer Ramkishan (Dr.)
    • Asst.
    • Drugs Controller, CDSCO, Sub Zonal Office, India
  • Day 2 > Session 1-2

In-Jin Jang (Professor)

  • In-Jin Jang (Professor)
    • Seoul National University, Republic of Korea
  • Day 2 > Session 1-3

Adrian Waterson (Mr.)

  • Adrian Waterson (Mr.)
    • Asia Regulatory Director, AstraZeneca, UK
  • Day 2 > Session 2-1

Yuki Ando (Dr.)

  • Yuki Ando (Dr.)
    • Principal Reviewer of Biostatistics
    • Office of New Drug Ⅱ, PMDA, Japan
  • Day 2 > Session 2-2

Herng-Der Chern  (Dr.)

  • Herng-Der Chern (Dr.)
    • Distinguished Researcher
    • CDE, Chinese Taipei
  • Day 2 > Session 2-3

Hidefumi Nakamura  (Dr.)

  • Hidefumi Nakamura (Dr.)
    • Director
    • Division of Clinical Research
    • National Center For Child Health and Development, Japan
  • Day 2 > Parallel Tracks > Track 1-1

An Vermeulen  (Dr.)

  • An Vermeulen (Dr.)
    • Head
    • Modeling & Simulation Department
    • Johnson & Johnson, Belgium
  • Day 2 > Parallel Tracks > Track 1-2

Jean W. Temeck  (Dr.)

  • Jean W. Temeck (Dr.)
    • Lead Medical Officer, Office of Pediatric Therapeutics (OPT)
    • Office of International and Special Programs (OISP)
    • Office of the Commissioner (OC), CDER, FDA, USA
  • Day 2 > Parallel Tracks > Track 1-3

Agnes Chan (Ms.)

  • Agnes Chan (Ms.)
    • Regulatory Consultant
    • Pharmaceuticals & Biologics Branch
    • Health Products Regulation Group, HSA, Singapore
  • Day 2 > Parallel Tracks > Track 1-4

Jacques Morenas (Dr.)

  • Jacques Morenas (Dr.)
    • Assistant Director
    • Inspectorate and Companies Department
    • AFS-SAPS, France
  • Day 2 > Parallel Tracks > Track 2-1

Lembit Rago (Dr.)

  • Lembit Rago (Dr.)
    • Coordinator, QSM, Essential Medicines Pharmaceutical Policies Department
    • WHO, Switzerland
  • Day 2 > Parallel Tracks > Track 2-2

Susanne Keitel  (Dr.)

  • Susanne Keitel (Dr.)
    • Director
    • EDQM, Council of Europe, France
  • Day 2 > Parallel Tracks > Track 2-3

Megan Keaney  (Dr.)

  • Megan Keaney (Dr.)
    • Principal Medical Adviser, TGA, Australia
  • Day 2 > Parallel Tracks > Track 3-1-1

Deborah Monk (Ms.)

  • Deborah Monk (Ms.)
    • Director
    • Innovation and Industry Policy
    • Medicines Australia, Australia
  • Day 2 > Parallel Tracks > Track 3-1-2

Jennifer Chen (Ms.)

  • Jennifer Chen (Ms.)
    • Director
    • Legal Affairs
    • RDPAC, P.R. China
  • Day 2 > Parallel Tracks > Track 3-2

Yota Kikuchi (Mr.)

  • Yota Kikuchi (Mr.)
    • Manager
    • Promotion Code & Public Affairs
    • Sanofi-Aventis, Japan
  • Day 2 > Parallel Tracks > Track 3-3

Peter Richardson (Dr.)

  • Peter Richardson (Dr.)
    • Responsible for Biological Quality of Medicines
    • Human Medicines Development and Evaluation
    • EMA, UK
  • Day 2 > Session 3-1

Fermin Ruiz de Erenchum (Dr.)

  • Fermin Ruiz de Erenchum (Dr.)
    • Leader
    • Special Regulatory Task Force
    • Hoffmann-La Roche Ltd.,
  • Day 2 > Session 3-2

Joyce Wang (Ms.)

  • Joyce Wang (Ms.)
    • Division of Drugs & New Biotechnology Products
    • Food and Drug Administration
    • Department of Health, Chinese Taipei
  • Day 2 > Session 3-3

Day3

John W. Kiser (Mr.)

  • John W. Kiser (Mr.)
    • Senior Director
    • Global Pharmaceutical Regulatory Affairs
    • Submission Operations & Strategic Initiatives, Abbott Laboratories, USA
  • Day 3 > Session 1-1

Gary M. Gensinger (Mr.)

  • Gary M. Gensinger (Mr.)
    • Deputy Director
    • Office of Business Informatics
    • CDER, FDA, USA
  • Day 3 > Session 1-2

Jalene Poh (Ms.)

  • Jalene Poh (Ms.)
    • Regulatory Consultant
    • Pharmaceuticals & Biologics Branch, Pre-Marketing Division
    • Health Products Regulation Group, HSA, Singapore
  • Day 3 > Session 1-3

Joungwon Oh (Dr.)

  • Joungwon Oh (Dr.)
    • Deputi Director
    • Pharmaceutical Safety Bureau, KFDA
    • Republic of Korea
  • Day 3 > Session 2-1

Paul Eisenberg (Dr.)

  • Paul Eisenberg (Dr.)
    • Senior Vice President
    • Global Regulatory Affairs and Safety
    • Amgen, USA
  • Day 3 > Session 2-2

Rebecca Wang (Dr.)

  • Rebecca Wang (Dr.)
    • Head of Drug Safety Operation
    • Regional Center for Asia Pacific
    • Roche, P.R. China
  • Day 3 > Session 2-3

Patricia Mozzicato (Dr.)

  • Patricia Mozzicato (Dr.)
    • Chief Medical Officer
    • MSSO, USA
  • Day 3 > Session 2-4

Yoshiaki Uyama (Dr.)

  • Yoshiaki Uyama (Dr.)
    • Director
    • Division of Regulatory Research
    • Office of Regulatory Science, PMDA,Japan
  • Day 3 > Session 3-1

Romi Singh (Dr.)

  • Romi Singh (Dr.)
    • Executive Director
    • Global Regulatory Affairs & Safety
    • Amgen, USA
  • Day 3 > Session 3-2

Lembit Rago (Dr.)

  • Lembit Rago (Dr.)
    • Coordinator, QSM, Essential Medicines Pharmaceutical Policies Department
    • WHO, Switzerland
  • Day 3 > Session 3-3