Live Online Conference: GMP for Cannabis – Regulatory-Post-Conference

Live Online Conference: GMP for Cannabis – Regulatory-Post-Conference

Course No 18706

Note: All times mentioned are CEST.


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Univ-Doz. Dr Reinhard Länger, Austrian Agency for Health and Food Safety (AGES)
Dr Ana Paula Martins, Assessor, Infarmed, Portugal
Angela Müller, Dr. Willmar Schwabe, Germany
Dr Constantin von der Groeben, DEMECAN, Germany
Silvia von Pistor, Tilray, Germany

Technical Requirements

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Note: Provisional timetable, the actual schedule may vary depending on the situation.
13.00 – 13.15 h Welcome and Introduction

13.15 – 14.00 h
Quality Requirements for Applications for Marketing Authorization
  • Borderline GACP-GMP
  • Types of extracts
  • Control strategy for extracts and drug products
  • Context with clinical data and regulatory pathway
14.00 – 14.15 h
Time for Discussion
14.15 – 14.30 h Break
14.30 – 15.15 h
GACP – Regulatory Information
  • Herbal Drugs
  • Framework
  • GACP vs. GMP
    • Guidelines
    • Interpretation
  • Information in the Dossier
    • Mockup
    • Grower and Supplier
    • Geographical source
    • Herbal substance Manufacturing
15.15 – 15.45 h
Regulatory Requirements for Marketing Authorization
  • Is a complete dossier always required?
  • Special procedures created by several MS, like Portugal & Denmark
15.45 – 16.00 h
Time for additional Questions and Discussion
16.00 – 16.15 h Break
16.15 – 16.45 h
Regulatory Submission in Portugal
  • Challenges
  • Practical aspects
  • Clinical indications
16.45 – 17.30 h
Regulatory Requirements for Cannabis Production in Germany
  • Interaction with the Cannabis Agency
  • Security Measures
  • Distribution to pharmacies
  • Production in Germany vs. Imports
17.30 – 18.00 h
Final Discussion

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