INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE SPECIFICATIONS:…

Common Technical Document (CTD) Dr Pravina ICRI What is the CTD? The CTD refers to an application format and not to an application type • The CTD is a prescribed organization…

ICH Q7A GMP Guidance for APIs and its Use During Inspections Office of Regional Operations Center For Drug Evaluation and Research U.S. Food and Drug Administration Rockville,…

1. Get All Pharmaceutical Guidelines on www.pharmaguideline.com Email- [email protected] CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION…

Slide 1EPAA Conference 5 November 2007 Georgette LALIS Enterprise and Industry DG European Commission The international dimension of regulatory acceptance Slide 2 EPAA Conference…

Slide 1 IUSS 2008 - Dr. A. Orlandi Lo sviluppo di un farmaco: dal laboratorio al mercato Slide 2 IUSS 2008 - Dr. A. Orlandi Fasi dello sviluppo di un farmaco Drug discovery…

1. Get All Pharmaceutical Guidelines on www.pharmaguideline.com Email- [email protected] CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION…

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE DRAFT CONSENSUS GUIDELINE ASSESSMENT AND CONTROL OF…

1. An Introduction to RiskManagement Michael D. Kaufer, MBA, MSCGMP Solutions, Inc.1 2. Learning Objectives ICH Q9  What are the basics of Risk?  Risk Tools …

1. PHARMACOVIGILANCEPHARMACOVIGILANCE & ICH GUIDELINES& ICH GUIDELINES Prepared by Mr.C.STALIN.M.Pharm.,(Ph.D) Technical Associate, Adverse events Monitoring Centre,…