Jubileuszowy Sejmik Zielarski
KOMUNIKAT I
Jubileuszowy Sejmik Zielarski z okazji 80. lecia Polskiego Komitetu Zielarskiego "Quo vadis phytopharmaka" organizowany przez Polski Komitet Zielarski we współpracy z Instytutem Włókien Naturalnych i Roślin Zielarskich
Żerków, 11-12 czerwca 2010 r.,
Ośrodek Konferencyjno-Szkoleniowy Mickiewiczowskiego Centrum Turystycznego w Żerkowie oraz Muzeum Adama Mickiewicza w Śmiełowie»
Konkurs na funkcję Dyrektora IWNiRZ
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Trainings for persons running herbal -pharmacy shops
Polish version only
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PN-EN ISO 9001:2001, GMP, GEP
The quality of work and services is guaranteed by the integrated quality management system implemented in the Institute.»
Guarantee Mark
Quality Supporting Programme - Effective and Safe Herbal Products, initiated by the Research Institute of Medicinal Plants, is aimed at distinguishing products of proved quality...»
The analyses offered by the Institute of Natural Fibres and Medicinal Plants mainly concern the identification, purity control and identifying contents of substances with pharmacological activities or markers, as well as the levels of microbiological and chemical contamination, including residues of chemicals used for plant protection, toxic metals and residues of organic solvents.
The methods used in analytical works are those presented in Pharmacopeas (FP, Ph Eur, NF USP), methods employed by the client or methods prepared by the Institute to the client's order.
We carry out validations of analytical methods provided by the customer.
In the analyses modern methods are used, including UV-VIS spectometry, densitometry, thin-layer chromatography (TLC and HPTLC), high performance liquid chromatography (HPLC) and ultra performance liquid chromatography (UPLC), liquid chromatography with UV-VIS, DAD, FLD and MS/MS detection, gas chromatography (GC) with NPD, ECD and FID detection, as well as AAS:FAAS and GFAAS spectometry.
The Research Institute of Medicinal Plants carries out complex analyses of herbal materials nad products, medicinal products, including veterinary drugs and food, especially dietary supplements and border-line products.
We design recipies and technologies concerning herbals production and prepare registration documents to medicinal products, including expert reports on chamical, pharmaceutical, biological, toxicological and pharmacological, as well as clinical (in accordance with NTA or CTD) documentation together with a clinical expert assessment concerning monitoring safety of medicinal products.
When alimentary products are concerned, we attach reports on qualifications, aim and declared properties, as well as the application forms for the new food.
The Institute also carries out analyses of stability, identifications of the levels of contents of micro- and macroelements and microbiological control of the production environment in the producing company.
We prepare and coordinate preclinical, clinical and pharmacogenetic trials, integrated with the quality management system ISO 9001:2001.
The preclinical trials, carried out in rodents and pigs include:
- toxicological analyses
- acute toxicity
- short-term toxicity at repeated administration and subchronic toxicity
- chronic toxicity
- local skin reactivity
- direct pharmacological tests
Clinical trials of medicinal products and herbal products are conducted according to the GCP/HCP requirements (Phase I-IV) and include:
- designing trials, preparing trial protocol, and trial documentation, CRF projects, choice of method, size of trial, choice of criteria to assess efficiency, choice of randomisation method, plan of statistical analysis, in-process analyses
- trial registration in the Central Database of Clinical Trials, preparing the registration files, completing trial documentation
- procedures of achieving opinions of Bioethical Committees
- recruting volunteers, research centres and analytical laboratories
- monitoring trial procedure in accordance with GCP rules, high quality analyses carried out in accordance with ISO 9000:2000
- databases of trial results, entering data to databases, interpretation and analyses of results, statistical analysis
- preparing final reports
- carrying out legal and accounting documentation concerning those for trials participants
We also preform analyses of bioequivalence and bioavailability for new medicinal products and generics.
The Research Institute of Medicinal Plants organises courses for pharmacists, a course in herbal products for herbal and medicinal products providers and courses in agriculture consulting.
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Quality Supporting Programme - Effective and Safe Herbal Products, initiated by the Research Institute of Medicinal Plants, is aimed at distinguishing products of proved quality...
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