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Dr Andreas Hofmann
Phytos GmbH & Co. KG, Germany
Dr Bernhard Klier
PhytoLab GmbH & Co. KG, Germany
Dr Sven Oliver Kruse
Diapharm GmbH & Co. KG, Germany
Dr Christian Lottner
Bionorica SE, Germany
Dr René Roth-Ehrang
Dr Alexander Schenk
Zeller AG, Switzerland
This course will provide you with the necessary knowledge to control the quality of Herbal Medicinal Products (HMPs). You will learn about all aspects that are needed to build up the CTD quality module 3 for your registration dossier. This includes legal and regulatory requirements as well as analytical methods and the challenges often encountered in HMPs.
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 - but also as food supplements - they all need to fulfill the same quality standards. However, HMPs have some specific characteristics that must be taken into consideration for quality control measures to produce sound analytical results – especially when these quality control measures have to remain economically viable:
Due to their high number of constituents HMPs are complex in nature.
The constituents belong to different chemical classes with different analytical behaviour.
Constituents have different and sometimes very low concentrations in the finished product.
This two-day course will furnish you with the necessary knowledge to develop intelligent and pragmatic solutions for the analysis of HMPs. You will learn about the
Legal and regulatory framework
Characteristics of HMPs
Quality control methods for HMPs
Typical obstacles and pitfalls
The combination of lectures and workshops will help you to retain and later apply the newly gained insights to your own products.
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 Medicinal Products.
The Regulatory Framework of Herbal Medicinal Products
Marketing authorization and registration
Particularities of Traditional Herbal Medical Products
Characteristics of HMPs
From Herbal Drug to Herbal Medicinal Product
Definition of the API
Defining marker substances and forced degradation studies
Special analytical methods
Quality of HMPs
Herbal drug sourcing
Setting specifications (Herbal Drug, Extracts, Herbal Medicinal Products)
Stability Testing of HMPs today
Stability testing - general requirements
Characteristic of HMPs
Particular analytical aspects of HMPs:
-Markers, methods, fingerprints, validation
Conversion of Analytical Methods HPLC/UHPLC -
The Sticking Points are in the Detail
Shorter running times and saving of solvents by conversion of analytical methods from HPLC to UHPLC
Existing methods can be converted easily in a large number of cases with the available translation tools
Further optimization of separation, particular in the case of complex mixtures of similar secondary components becomes possible with experience and some useful tricks
UHPLC equipment is often used for running conventional HPLC methods, sometimes with surprisingly different results and unexpected problems to be resolved
Contaminants in Herbal Drugs and Herbal Drug Preparations – Current Review
Contaminants in Ph.Eur:
Foodstuff Regulation (EG) No. 1881/2006
Relevance in practice
Dr Bernhard Klier
The European Variations Regulation/Guideline applied to (Traditional) Herbal Medicinal Products
Introduction and legal background of the European Variations Regulation
Supporting information and guidelines
Classification of variations: in general and specially focused on Herbal Medicinal Products
Handling of Variations: workflow and submission (e-CTD, CESP)
Some case studies
Some of the most important topics of this course will be further discussed in workshops on day 2.
1. Changes and Variations – How to handle for HMPs?
The aim of this workshop is to evaluate in small discussion groups how to come to valid variations step-by-step.
Participants are invited to send specific questions
regarding the practical handling of changes and
variations prior to this course directly to firstname.lastname@example.org
By the means of examples from analytical development and routine analysis participants will learn and discuss important tools for developing UPLC-methods for secondary natural component analysis. Conversion of HPLC to UHPLC methods are exercised on the basis of real examples.
3. Contaminants in Herbal Drugs and Herbal Drug Preparations – Examples from Daily Practice
In this workshop participants will discuss the following topics:
Sampling of herbal drugs
Pyrrolizidine Alkaloids (natural sources, analytical options, legal requirements, current situation in practice)
Pesticide residues (definition, regulation, contamination)
Participants will be able to attend all these 3 Workshops on Day 2.