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    PRODUCT CATEGORIES

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  • REGULATORY INFORMATION

  • Basic Regulation
  • Active Pharmaceutical Ingredients (API)
  • Bioequivalence and Ethics Committee Inspection
  • Compliance and Licensing
  • Good Clinical Practice (GCP) & Good Laboratory Practice (GLP)
  • Laboratory & Quality Control
  • Medicinal Gases
  • Pharmacovigilance
  • Phase I Unit Inspection & Accreditation Programme
  • Surveillance & Complaints
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  • Drug Registration Guidance Documents (DRGD)
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Announcement

1st Malaysia-Japan Symposium

Written by kobu · 9 July 2015

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  3. 1st Malaysia-Japan Symposium

Date: 02 April 2015

Description: Presentation Slides, evaluation forms and other documents.

Presentation Slides


Day 1

  • NPCB-An Overview (Siti Aida)
  • Role & Vision of PMDA (T. Hojo)
  • Japan regulatory system for pharmaceutical products & API (H. Yamada)
  • Malaysia Regulatory System for Pharmaceutical Products (Rosilawati)
  • Halal Pharmaceuticals (Tajuddin)
  • Malaysian Herbal Monograph (Mazli)
  • MHM (Mazli)
  • Japanese Pharmacopoeia (S. Miyazaki)


Day 2

  • Regulatory Control For TMHS in Malaysia (Shantini)
  • Regulatory Control for Generics (Khirul Falisa)
  • Risk based approaches in the Japan GMP Regulation (K. Hara)
  • Regulatory Framework for Biotherapeutic Products including Similar Biotherapeutic Products (Y. Kishioka)

Click here to download the evaluation form.

 

1st malaysiajapan final         Japan Technical Bilateral Meeting final

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