|Course code module||1MFAR-FZ-006|
|Study load (hours)||84|
|Language of instruction:||Dutch|
|Semester exam information:||exam in the 2nd semester|
|Contract restriction information:|
The course on phytotherapy is part of the course on pharmacotherapy, but is specifically directed towards the treatment of mild to moderate symptoms of diseases, which are not life threatening. This course, however, differentiates from the classical pharmacotherapy, because herbal medicinal products can obtain a marketing authorization or registration using an alleged procedure based upon traditional and/or for well-established use.
Bachelor Pharmaceutical Sciences : Pharmacognosy I : Phytochemistry, Pharmacology and Applied Pharmacokinetics
Pharmacognosy I, part : Phytochemistry (3BFAR-02) AND Pharmacology and Applied Pharmacokinetics (3BFAR-08)
2. Objectives (expected learning outcomes)
Transfer of current knowledge on the mostly used herbal medicinal products concerning their pharmaceutical quality, pharmacological activity and safety and their therapeutical activity according to clinical studies.
Learn students to distinguish between herbal medicinal products which have obtained a marketing authorization or registration based upon clinical studies (WHO categories I and II), literature data (WHO category III) or traditional use (WHO category IV).
Learn the students to compose herbal teas which can be used in the pharmacy for one of the acceptable indications of the lists.
Learn the students to elaborate Community Monographs on herbal medicinal products according to the EMEA criteria.
3. Course content
Until the end of 2006 herbal medicinal products could obtain a Belgian marketing authorisation according to an alleged procedure based upon lists of medicinal plants with mandatory therapeutic indications (27 lists containing about 180 plants). Since 2007, however, herbal medicinal products should be categorized into well-established and traditional herbal medicinal products according to the criteria determined by the European Medicines Agency (EMEA) in London.
The most used herbal medicinal products in Europe will be discussed according to Community Herbal Monographs developed by the Committee on Herbal Medicinal Products (HMPC) of the EMEA. These monographs are intended to help pharmaceutical companies to obtain easier a marketing authorisation (MA) or registration of well-established or traditional herbal medicinal products. The monographs contain data on subsequently the qualitative and quantitative composition, pharmaceutical form, clinical particulars (therapeutic indications, posology and method of administration, contra-indications, special warnings and precautions for use, interactions, pregnancy and lactation, effects on ability to drive and use machines, undesirable effects, overdose) and pharmacological properties (pharmacodynamic, pharmacokinetic, and preclinical safety data).
Moreover, both classes of herbal medicinal products should be distinguished.
4. Teaching method
Direct contact: LecturesSeminars (possible question and answer sessions)
Personal work: Assignments - in groupPaper - in groupSupervised self-studyProject-based work - in group
5. Assessment method
Continuous assessment: AssignmentsParticipation in classroom activities
6. Compulsory reading – study material
Handouts of ESCOP and BHC monographs
Community Monographs of the HMPC via the website of EMEA
7. Recommended reading - study material
ESCOP Monographs second edition, Thieme Verlag 2003