Live Online Conference: GMP for Cannabis – Regulatory-Post-Conference
Im Auftrag der ECA Academy

Live Online Conference: GMP for Cannabis – Regulatory-Post-Conference Im Auftrag der ECA Academy

Seminar Nr. 18706

Note: All times mentioned are CEST.

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Kosten

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Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

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

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because
of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programm

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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