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  Terveyden tutkimuksesta tuotteeksi -seminaari 30.1.2002Anna-Maija Autere, Lääkelaitos Biotechnological Medicinal ProductsBiotechnological Medicinal ProductsQualityQuality  Requirements for authorised biotech products  EU guideline on the Comparability of biotech products  General quality requirements for investigational biotechnological products used in clinical trials in Finland   Frequently asked questions  Appendix: List of biotech quality Note for Guidances (   Terveyden tutkimuksesta tuotteeksi -seminaari 30.1.2002Anna-Maija Autere, Lääkelaitos AuthorisedAuthorised biotechnological productsbiotechnological productsQuality requirements (EU)Quality requirements (EU)  Biotech Quality Notes for Guidance  –  Vol. 3A,   –  NfG,  ã(Human Medicines;Regulatory Guidance&Procedures;Notesfor Guidance; Biotechnology, ICH, Quality)  European Pharmacopoeia (e.g. monographs on: dosage forms,vaccines, products of recombinant DNA technology)  Quality requirements on authorised products guaranteepredictable in vivo   characteristics of commercial batches  Terveyden tutkimuksesta tuotteeksi -seminaari 30.1.2002Anna-Maija Autere, Lääkelaitos Investigational   Investigational biotechnological products inbiotechnological products inclinical trials -Quality requirements (FI)clinical trials -Quality requirements (FI)  Regulation 1/2001, Appendix 1: 1. Biological, Chemical andPharmaceutical information (  –  Provide adequate quality data   Safety of the trial should be demonstrated in the notification  –  adequacy of the data determined case by case: product, aimof the study, phase  Adequate quality requirements impact on the usefulness of theresults →→→→  optimisation of the clinical stage of the productdevelopment  Terveyden tutkimuksesta tuotteeksi -seminaari 30.1.2002Anna-Maija Autere, Lääkelaitos Regulation 1/2001Regulation 1/2001Batch used in the clinical trialBatch used in the clinical trial  The batch in the clinical trial is the same product that is  –  presented in the quality part of the notification  –  used in the pre-clinical studies  →→→→  All changes in the product (active ingredient, pharmaceuticalform, excipients, specifications, process) must be reported & justified, and comparability demonstrated and new notificationsubmitted when necessary  GMP , manufacturing licence of the manufacturing place  –  prerequisites for the use of any batch in a clinical trial!


Jul 23, 2017
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