Quality of Herbal Medicinal Products

| Prague, Czech Republic
ECA - European Compliance Academy

Herbal medicinal products (HMPs) are accepted and widely-used remedies. They must fulfil the same quality standards as their chemically defined counterparts. However, herbals have specific characteristics which need to be taken into consideration, especially in quality control. During the two-day course “Quality of Herbal Medicinal Products” Diapharm’s Dr Sven Oliver Kruse will discuss the particular challenges for stability testing in this context. The course provides the necessary knowledge of legal requirements, analytical methods and typical challenges to control the quality of HMPs.

Due to their high number of constituents HMPs are complex in nature. The constituents usually belong to different chemical classes with different analytical behaviour and sometimes with very low concentrations in the finished product. The European Compliance Academy has prepared a combination of lectures and workshops that will help participants gain and apply knowledge of typical quality control tasks and issues in herbal medicines:

  • The Regulatory Framework of Herbal Medicinal Products (Dr. René Roth-Ehrang, Amway)
  • Characteristics of HMPs (Dr. Andreas Hofmann, Phytos)
  • Quality of HMPs (Dr. Andreas Hofmann, Phytos)
  • Stability Testing of HMPs today (Dr. Sven Oliver Kruse, Diapharm)
  • Conversion of Analytical Methods HPLC to UHPLC (Alexander Schenk, Zeller)
  • Contaminants in Herbal Drugs and Herbal Drug Preparations – Current Review (Dr. Berndhard Klier, PhytoLab)
  • The European Variations Regulation/Guideline applied to (Traditional) Herbal Medicinal Products (Dr. Christian Lottner, Bionorica)

The two-day course is accompanied by workshops focusing on:

  • WORKSHOP I: Changes and Variations - How to Handle for HMPs?
  • WORKSHOP II: UHPLC
  • WORKSHOP III: Contaminants in Herbal Drugs and Herbal Drug Prepara-tions – Examples from Daily Practice Contaminants in Herbal Drugs

The course is designed for staff members in pharmaceutical and API industry’s quality control, regulatory affairs, production and purchasing departments who need to establish, monitor and/or manage the quality of Herbal Medicinal Products.

Contact:
Diapharm GmbH & Co. KG
Dr. Sven Oliver Kruse
Phone: +49 (0)251 60935-0
E-Mail

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