PDF-European Medicines Agency 7 Westferry Circus Canary Wharf London E14 4

Author : ethlyn | Published Date : 2021-10-03

ICH Topic E 1 Population Exposure The Extent of Population Exposure to Assess Clinical Safety Step 5NOTE FOR GUIDANCE ON POPULATION EXPOSURE THE EXTENT OF POPULATION

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European Medicines Agency 7 Westferry Circus Canary Wharf London E14 4: Transcript

ICH Topic E 1 Population Exposure The Extent of Population Exposure to Assess Clinical Safety Step 5NOTE FOR GUIDANCE ON POPULATION EXPOSURE THE EXTENT OF POPULATION EXPOSURE TO ASSESS CLINICAL SAFETY. 4420 74 18 84 00 Fax 4420 74 18 84 09 Email mailemeaeuropaeu httpwwwemeaeuropaeu EMEA 2008 Reproduction andor distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London 11 December 2007 CPMP Canary Wharf London E14 4HB An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 E - mail info@ema.europa.eu Website www.ema.europa.eu Canary Wharf London E14 4HB An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimil e +44 (0)20 7418 8416 E - mail info@ema.europa.eu Wbsite www.ema.europa.eu Canary Wharf London E14 4HB United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7129 E - mail info@ema.europa.eu Website Canary Wharf London E14 4HB United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7129 E - mail info@ema.europa.eu Website www.ema.europa.eu ICH Considerations General Principles to Address the Risk of Inadvertent Germline Integration of Gene Therapy Vectors TRANSMISSION TO CHMP November 2006 RELEASED FOR INFORMATION November 2006 (CHMP) REFLECTION PAPER DRAFT AGREED BY BIOSIMILAR MEDICINAL PRODUCTS WORKING PARTY (BMWP) October 2007 KEYWORDS Interferon alfa, recombinant, similar biological medicinal products, comparability, (CHMP) GUIDELINE ON STRATEGIES TO IDENTIFY AND MITIGATE RISKS FOR FIRST-IN- HUMAN CLINICAL TRIALS WITH INVESTIGATIONAL MEDICINAL PRODUCTS DRAFT AGREED BY CHMP EXPERT GROUP 6 March 2007 ADOPTION BY Canary Wharf London E14 4HB United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7129 E - mail info@ema.europa.eu Website www.ema.europa.eu Comparability of Biotechnological/Biological Products Step 5 NOTE FOR GUIDANCE ON BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS CPMP/ICH/5721/03TRANSMISSION NOTE FOR GUIDANCE ON STABILITY TESTING: STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS (CPMP/ICH/2736/99) SION TO CPMP November 1999 RELEASE FOR CONSULTATION November 1999 DEADLINE FOR COM ICH Topic Q 5 B Quality of Biotechnological Products: Analysis of the Expression Construct in Cell Lines Used for Production of r-DNA Derived Protein Products NOTE FOR GUIDANCE ON QUALITY OF BIOTE (CHMP) GUIDELINE ON FOLLOW-UP OF PATIENTS ADMINISTERED WITH GENE THERAPY MEDICINAL PRODUCTS AGREED BY GENE THERAPY WP April 2008 AGREED BY PHARMACOVIGILANCE WP March 2008 ADOPTION BY CHMP FOR REL

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