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The Taj Mahal Hotel - New Delhi

2017年7月11日 (火) 午前 8:30 - 2017年7月12日 (水) 午後 6:00

No. 1,, Mansingh Road,, New Delhi 110011, New Delhi, India

EFPIA DIA OPPI Regulatory Workshop

概要

Participants will have the opportunity to interact with regulators including WHO, DCG(I), Indian MoH and Members of European Federation of Pharmaceutical Industries and Associations (EFPIA India Regulatory Network) and the Organisation of Pharmaceutical Producers of India (OPPI) on key regulatory topics including Orphan drug regulation, Clinical trial waiver, Accelerated regulatory pathway and Biological product/ Biosimilars registration in India.

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参加対象

WHO SHOULD ATTEND

  • Regulatory Affairs professionals
  • Assessors in regulatory authorities

    学習目的

    This workshop aims to bring together regulators and implementers to exchange viewpoints on key regulatory topics including Orphan drug regulation, Clinical trial waiver, Accelerated regulatory pathways and Biological product/Biosimilars registration in India.

    プログラム委員会

    • Shekhar   Natarajan
      Shekhar Natarajan Head-International Regulatory Strategy
      Shire, United Kingdom, United Kingdom
    • Bente  Brunbakke
      Bente Brunbakke Regional Manager-Gulf, India and Egypt,
      Novo Nordisk A/S, Denmark
    • Nagaraj  Bannur
      Nagaraj Bannur Head-Regulatory Affairs and Patient Safety, India and Subcontinent
      AstraZeneca Pharma India Limited, India
    • Finny  Liu, MSc, RPh
      Finny Liu, MSc, RPh APAC Regional Regulatory Policy Lead
      Roche, Singapore
    • Kum Cheun  Wong, PharmD
      Kum Cheun Wong, PharmD Head Asia Pacific Regulatory & Development Policy
      Novartis Asia Pacific Pharmaceuticals Pte. Ltd., Singapore
    • Thean Soo  Lo
      Thean Soo Lo
      Regulatory Affairs Management Consultant, Singapore

    Digital Learning Catalog

    DIA Learning: eLearning Soultions
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