GMP for Herbal Medicinal Products (HMPs) - Live Online Conference
8/9 October 2025
Course No. 21366
Speakers
Dr Ulrich Rose
Straßburg
Dr René Roth-Ehrang
Finzelberg
Dr Evelyn Wolfram
Zurich University of Applied Sciences
Dr Henrik Harms
BfArM
Dr Nikos Xynos
Nomad Labs Scientific
Philip Junker Andersen
IntuBio
Joaquin Dell’Acqua
Agronomist
Dr Gerlinde Kugler
Austrian Agency for Health and Food Safety (AGES)
Note: All times mentioned are CEST.
Objectives
The course will provide you with the necessary GMP/GACP knowledge for Herbal Drugs, Herbal Drug Preparations (e.g. Extracts) and Herbal Medicinal Products (HMPs). This includes regulatory & quality requirements as well as applicable pharmacopoeial monographs and challenges often encountered in HMPs, e.g. during stability studies.
Background
Herbal Medicinal Products are accepted and widely-used remedies. Although several routes exist for HMPs to receive a marketing authorization, e.g. well-established or traditional use – or special cases like medical cannabis as “Formula magistralis / officinalis” without marketing authorization - they all need to fulfill the same pharmaceutical quality standards. However, HMPs have some very specific characteristics that must be taken into consideration for GMP compliant production, quality control, release and stability testing. Questions often raised include the following:
Which contaminants have to be considered?
Which microbiological provisions apply?
Which kind of decontamination procedures can be used?
Are there different requirements for herbal drugs, herbal drug preparations (like extracts) and the final HMP?
To provide more detailed information on these requirements, the European Medicines Agency (EMA) recently published the final guidelines (Revision 3) on quality and specifications for herbal medicinal products (HMPs). Amongst others, a written GACP confirmation for the herbal substance should be provided either by the herbal drug supplier or the manufacturer of the active substance / the HMP. In addition, EMA´s HMPC is currently working on the revision of the GACP guideline and recently already published a draft paper.
Target Group
This course is designed for all people in pharmaceutical and API industry’s quality control, regulatory affairs, pharmacovigilance, production and purchasing departments who need to establish, monitor and/or manage the quality of Herbal Drugs / Herbal Medicinal Products.
Date & Technical Requirements
Date 08/09 October 2025 Wednesday, 8 October 2025, 9.00 to approx. 17.30 h (CEST) Thursday, 9 October 2025, 9.00 to approx. 13.00 h (CEST)
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Testimonials
Seminar Programme as PDF