Registration of medicines in Vietnam

Registration of medicines in Vietnam

Details

  • Start date: 08 December 2022
  • Start time: 09:00 (Kyiv)
  • Finish date: 08 December 2022
  • Finish time: 13:00 (Kyiv)
  • Duration: 4 hours + Q&A session
  • Break: yes
  • Category: Registration of medicines
  • Format: Streaming
  • Online broadcast available: yes
  • Venue: Online
  • Language class: English
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    THE KEY TOPIC OF PHARMACEUTICAL PRODUCT REGISTRATION IN VIETNAM
     

    SECTION # 01

    THE DRUG REGULATORY LANDSCAPE IN THE ASEAN REGION (VIETNAM)

    o    Introduction

    o    The ASEAN Region

    o    The Pharmaceutical Inspection Co-operation Scheme

    o    Certificate of Pharmaceutical Product (CPPs)

    o    ACTD/CTD Acceptability

    o    Pharmacopoeias Acceptability

    o    Harmonization of Technical Guidelines

    o    Stability

    o    Product Labeling

    o    Post Approval Changes (Variations)

    o    Pharmacovigilance and Risk Management Plan (RMP)

     

    SECTION # 02

    MARKET DRIVERS & LEGAL LAWS WITH REGULATORY PROCESS

    o    Reasons for pharmaceutical market growth in Vietnam

    o    Opportunities for foreign generic drug manufacturers in Vietnam

    o    Legal Basis

    o    Regulatory Authority & Jurisdiction

    o    The Drug Regulatory Process

    o    Requirements For New Registration Dossier

    o    Technical Guidelines And Checklist

     

    SECTION # 03

    DRUG REGISTRATION PROCESS

    o    Marketing Approval Procedures

    o    Types Of Drug Registration

    o    Required Dossiers

    §  Specific Regulations For The Administrative Dossier And Product Information

    §  Specific Regulations For Quality Dossier

    §  Specific Regulations For Pre-Clinical Dossier

    §  Specific Regulations For Clinical Dossier

    o    Country-Specific Requirements For Vietnam

    o    Labeling Requirements (Country-Specific) – Vietnam

    o    Validity of Drug Registration

    o    Bioequivalence Studies

    o    Technical Comparison

    §  General Information

    §  Administrative Documents Comparison

    §  Technical Documents Comparison

    §  Regional Format Comparison

    o    Steps Involved To The  Issuance of a Marketing Registration Certificate

     

    SECTION # 04

    ADDITIONAL INFORMATION & CONCLUSION

    o    Updates: New Regulations On Drug Registration In Vietnam

    o    Overview of Approved Registration Dossier

     

    o    Conclusion