Creative Writing

BT-Biotechnological Medicinal Products Biotechnological Medicinal Products

Description
medicinal products
Published
of 19
All materials on our website are shared by users. If you have any questions about copyright issues, please report us to resolve them. We are always happy to assist you.
Related Documents
Share
Transcript
  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 (www.nam.fi)   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, dg3.eudra.org/F2/eudralex/vol-3/home.htm   –  NfG, www.emea.eu.int  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 (www.nam.fi)  –  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!

Lesson_2.4

Jul 23, 2017
Search
Tags
Related Search
We Need Your Support
Thank you for visiting our website and your interest in our free products and services. We are nonprofit website to share and download documents. To the running of this website, we need your help to support us.

Thanks to everyone for your continued support.

No, Thanks