EU GMP Requirements
Trade & Industry Inspection Agency ofLower Saxony / Germany, Hannover officeBernd BoedeckerGMP Inspectorate of Hannover / GermanyEU GMP Requirements - Investigational Medicinal Products -at Turkish Ministry of HealthAnkara, 20-21 Oct 2009TMH, Ankara, 20-21 Oct 2009Bernd Boedecker2Trade & Industry Inspection Agency ofLower Saxony / Germany, Hannover officecontact dataBernd BoedeckerStaatliches Gewerbeaufsichtsamt HannoverDezernat 74 (GMP Inspectorate)Am Listholze 74D-30177 Hannoverphone: +49 (0)511 / 9096-464fax : +49 (0)511 / Ankara, 20-21 Oct 2009Bernd Boedecker3Trade & Industry Inspection Agency ofLower Saxony / Germany, Hannover officeContents covered Legislationrelated to Investigational Medicinal Products(IMPs) IMP terminology Focal points of inspectionsat IMP manufacturing sites Revision of Annex 13 current status GMP level of Active Ingredientsfor Use in IMPsTMH, Ankara, 20-21 Oct 2009Bernd Boedecker4Trade & Industry Inspection Agency ofLower Saxony / Germany, Hannover officeLegal framefor manufacture & import of IMPs Directive 2001/20/EC (Good Clinical Practice basics) Article 9: conduct of a clinical study subject to ethical evaluation and authorisation Article 13: manufacture and import of IMPs subject to holding of an authorisation Directive 2005/28/EC (Clinical Trials Directive) Article 10: Requirements fo
Trade & Industry Inspection Agency of Lower Saxony / Germany, Hannover office Bernd Boedecker GMP Inspectorate of Hannover / Germany EU GMP Requirements
Download EU GMP Requirements
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document:
Related search queries
MANUFACTURING PRACTICE GUIDELINE FOR, MANUFACTURING PRACTICE GUIDELINE FOR PHARMACEUTICAL PRODUCTS, Up Your Analytical Method Transfer, Technical Rteport, Research, SAMPLING AND ANALYSIS FOR ATMOSPHERIC MERCURY, Contract quality control, Of critical and major observations from, Manufacturing, QC and Contract Research