Předmět Registration of Drugs and Patent Protection (S110025)

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Materiál	Typ	Datum	Počet stažení

Sylabus

1. Lifecycle of a medicinal product, regulatory system on medicinal products for human use within the Czech Republic and EU, activities and responsibilities of the State Institute for Drug Control, lifecycle of the medicinal product.2. Placement of the medicinal product on the market, borderline products, non-authorised use, falsified medicines - enforcement.3. Legal framework for the licensing, manufacturing and distribution of medicines in CR (Act on Pharmaceuticals 378/2007, decrees) and in EU ( Decisions, Directives, Regulations, texts Community hierarchy).4. The requirements and procedures for the marketing authorisation for medicinal products for human use(Directive 2001/83/EC, centralised procedure CP), mutual recognition procedure (MRP), decentralised procedure (DCP), national procedures NP). 5. Patent protection on pharmaceuticals, Supplementary Protection Certificate (SPC), Data/ Market Exclusivity. 6. Basic principles for distinguishing between medicinal products for human use and other products, availability of product information (SmPC, PIL, labelling, EPAR).7. Clinical trials, types of studies, basic requirements for approval procedures (regulatory authoritiy/ethics committee). 8. CTD - Common Technical Document, Modules 1-5, ICH harmonisation. 9. Module 3 - Quality - chemical-pharmaceutical and biological information, ASMF (DMF, PMF, VAMF), Ph.Eur. Certificate of suitability. 10. Module 4 - non clinical study reports, Module 5 - clinical study reports. 11. The Anatomical Therapeutic Chemical (ATC) classification system, dispensing of medicinal products, OTC medicinal products, sale of selected medicinal products. 12. The rules for the constant supervision of products after they have been authorised -post-authorisation "life" of medicinal products, (PSUR, variation, renewal, withdrawal of authorisation), basic principles of pharmacovigilance. 13. Databases and information systems (AISLP, IDRAC, EudraPharm, EudraCT, EudraVigilance…) .14. Lifecycle management of dossiers - ECM (Enterprise Content Management), PIM (Product Information Management), eCTD (electronic Common Technical Document

Garant

Kovářová Zdenka Ing. CSc.