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.


Für dieses Online Seminar ist leider keine Aufzeichnung verfügbar. Haben Sie jedoch Interesse, an einem kommenden Live Online Termin dieses Seminars teilzunehmen? Oder wünschen Sie eine individuelle Beratung zu unserem Schulungsangebot? Dann nutzen Sie einfach das folgende Kontaktformular, um uns Ihre Anfrage zu senden.

* auch unkompliziert per Kreditkarte bezahlbar American Express Visa Mastercard

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail:


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 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.


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


GMP Seminare nach Thema