|Course||11th Symposium on Herbal Medicinal Products in Europe 2022|
|Trainer||Prof. Dr. Markus Veit
Univ.-Doz. Dr. Reinhard Länger
BASG - Federal Office for Safety in Health Care | AGES - Austrian Agency for Health an Food Safety
Dr. Bernd Roether
Dr. Martin Ziak
Swissmedic Schweizerisches Heilmittelinstitut
Dr. Emiel van Galen
Dutch Medicines Evaluation Board CBG-MEB
Dr. Ulrich Rose
EDQM, Council of Europe
Dr. Nicole Armbrüster
Bundesverband der Pharmazeutischen Industrie e.V.
|Fee||€950.00 plus VAT.|
|Book for myself||Book for group|
This year, we have put the actual symposium into a European context and have looked at the topics covered beyond the DACH region. Particularly exciting was the presentation by Dr Emiel van Galen, who as HMPC Chair gave an outlook on the future work of the HMPC. Dr. Ziak took the 20th anniversary of Swissmedic as an opportunity to shed light on the world of phytopharmaceuticals from a Swiss perspective. Finally, it is part of the tradition of the symposium that we also take up controversial topics. For this purpose, I was able to win Dr Reinhard Länger, who dealt in his lecture with the not always simple interplay of the different requirements for herbal medicinal products, in the pharmacopoeia, the HMPC guidelines and other specifications. Another interesting question was how the marketing of herbal medicinal products established in Europe can be rolled out in countries outside Europe - also in the light of EU-specific regulations such as "well-established use" and traditional registration. Updates on current developments in the context of quality requirements for herbal medicinal products in Europe rounded off the programme.
Dr. Emiel van Galen, Chair HMPC, CBG-MEB
What comes after the monographs – The work of the HMPC in the future
Despite the somewhat acquiescent title ‘What comes after the monographs?’ we will shortly look back on what the HMPC has achieved the past years, and look ahead to see how the Committee stands at the doorstep of new challenges.
Dr. Martin Ziak, Swissmedic
Herbal medicinal products in Switzerland – A look back and tot he future on the occasion oft he 20th anniversary of Swissmedic
This year, 2022, Swissmedic can celebrate its 20th anniversary. The Swiss Therapeutic Products Act entered into force on 1st January 2002, thus laying the basis for an independent Swiss therapeutic products authority. The focus has always been, and still is, on the quality, safety and efficacy of therapeutic products in Switzerland. Innovation is advancing rapidly and Swissmedic is required to keep up with the latest developments. However, the anniversary year also provides an opportunity to look back on developments in the field of complementary and herbal medicinal products. On the other hand, it is an invitation to take a courageous look into the future.
Dr. Ulrich Rose (formerly EDQM)
Herbal medicinal products and respective starting materials in the European Pharmacopoeia – Retrospective and outlook
The European Pharmacopoeia (Ph. Eur.) lays down common quality standards for the manufacture and control of medicines in Europe and beyond. These quality standards - currently more than 2500 monographs and more than 370 general texts – cover active pharmaceutical ingredients, excipients, herbals, biologicals in their original state and in the form of pharmaceutical preparations and are legally binding for the 39 signatory parties to the Council of Europe’s Convention on the elaboration of a European Pharmacopoeia.
In the field of herbal drugs and preparations, there are currently six general monographs, like on herbal drugs, herbal drug extracts or essential oils, 27 general texts, like pesticide residues, heavy metals in herbal drugs, HPTLC of herbal drugs and preparations and more than 320 individual monographs.
The monographs are elaborated similarly to monographs on chemically defined APIs or biologicals, and contain sections on definition, characters, identification, tests and assay.
In recent times particular interest was attributed to the elaboration of general chapter 2.8.26, which describes the control of contaminant pyrrolizidine alkaloids in herbals. Furthermore, the replacement of classical physico-chemical assays, like photometry or HPLC, by semi-quantitative HPTLC in TCM drugs has been accepted as an alternative by the Ph. Eur. Commission. Further interesting and challenging projects, like monographs on cannabis, are in progress.
Dr. Reinhard Länger, BASG
Quality requirements for herbal substances, preparations and medicinal products: Has the optimum been achieved?
The system for quality control of herbal medicinal products appears to be clear: The European Pharmacopeia defines the quality criteria for a huge number of herbal substances and certain extracts. Additionally general classifications and requirements are provided. The HMPC elaborates guidance on the entire control strategy and the required documentation in the dossier. Both, Ph. Eur. and HMPC, make reference to each other, applicants apparently know what kind of data are required for acceptance of an application. However, when a closer look is taken on the required quality documentation from field to medicinal product, inconsistencies and space for improvement are evident. The presentation will provide some examples and intends to initiate an open-minded discussion.
Prof. Dr. Markus Veit, Alphatopics GmbH
Revised HMPC/QWP quality and specification guidelines for herbal medicinal products in Europe
The two central guidelines of the EMA and the HMPC addressing specifications and all quality aspects of herbal medicinal products and the corresponding herbal starting materials and herbal preparations used as API have been fundamentally revised over the last three years and adapted to the current state of science and technology. The final versions were published in May. With the revision, several requirements that were previously addressed in question-and-answer papers and reflection papers were integrated into the guidelines. In the presentation the most important aspects of this revision will be addressed.
Dr. Nicole Armbrüster, BPI
Regulatory update on contaminants
Testing for contaminants in herbal raw materials and preparations plays an important role in the manufacture of safe herbal medicinal products. There are numerous official requirements, both at a national and European level, which are intended to reduce the risk of contamination with undesirable and toxic substances to a minimum. This lecture will give an overview of the legal framework for compliance with the specifications for contaminants and impurities with regard to herbal substances and their preparations.
In recent years, the possible contamination with undesirable substances has posed great challenges to manufacturers of herbal medicinal products. The current developments regarding the debates about limit values of toxic substances (e.g. nitrosamines, estragole, polycyclic hydrocarbons) in the manufacture of herbal medicinal products will be presented.
Attendance fee online: € 950.- plus VAT per trained person
You can view all the presentations described via the recording link, in one piece or in parts whenever your schedule allows. You will receive a personalised access code, a certificate of attendance and the lecture documents as printable PDF documents.
If you are only interested in individual lectures, please contact us. We will make you a personal offer.
10% discount: For simultaneous registration of several persons from a single company. We are also happy to offer you and your team attractive special prices for groups. Please contact us.
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