Module 11: Herbal medicinal products

Abstract

Knowledge of the most important aspects of herbal substances, herbal preparations and herbal medicinal products, their production and qualityUnderstanding of the various regulatory frameworks governing these products and modified approaches for preclinical and clinical testing

Objective

Students understand the particularities of herbal medicinal products and are able to identify the areas in which a different approach from the typical ways of working for new and existing chemical entities and medicinal products are taken. Students: - understand raw material sourcing, the various types of active ingredients and the manufacturing processes thereof - comprehend and can explain the development process of herbal medicinal products with the strong distinctions in some documents generated for registration purposes - understand characteristics of preclinical and clinical herbal medicinal product research - get an insight in the complexity of regulations for products with herbal ingredients within a country and internationally - can analyze potential product profiles and define ways to market - can present their results written and orally

Content

This course focuses on the specifics of herbal medicinal products. From raw material sourcing to registration relevant differences to chemically defined actives and NCE are addressed in order to make the best use of knowledge gained during pharmaceutical studies. Introduction to herbal medicinal products; regulatory aspects; raw material sourcing; active ingredients; manufacturing and quality assurance; preclinical and clincial research; innovation.

Resources