1. Roles and Responsibilities of Sponsor as per GCP-ICHby Nagaraju B [email protected] 2. ICH-GCP is an International Conference on Harmonization for Good Clinical Practice.…

1. Roles and Responsibilities of Sponsor as per GCP-ICHby Nagaraju B 2. ICH-GCP is an International Conference on Harmonization for Good Clinical Practice.  GCP is an…

Slide 1Data Management seminar 05 th October 2011 Gwenlian Stifin & Aude Espinasse South East Wales Trials Unit, Cardiff University Slide 2 DATA MANAGEMENT OVERVIEW Aim…

Slide 1Understanding Our HRPP and Your Role in the Accreditation Process Slide 2 Introduction Eugene Oddone, MD, Vice Dean for Research Slide 3 3 What is AAHRPP? Association…

Slide 1Good Clinical Practice & Monitoring activities for the Roche Diagnostics dataset of the OPTIMIST trial 12-Dec-2012 Slide 2 Contents 2 Julius Clinical Good Clinical…

Slide 1ICH Harmonised Tripartite Guideline for Good Clinical Practice Part I (Principles, IRB/IEC, Investigator, Sponsor) Josip Arlica, MD Altiora Training Program “Train…

Slide 1Centre for Investigational New Product National Pharmaceutical Control Bureau, MOH Slide 2 OUTLINE Introduction Guidelines and Legal Requirements Application Process…

1. Basics of ICH-GCP, Good Clinical PracticeYves Geysels, PhD and Martijn Griep, PhDSymposium Klinische Studies; ervaringen van onderzoekers,KULeuven Campus KortrijkOctober…

Clinical Research Standard Operating Procedure (SOP) Usage Survey Report Ying Lu, MB, PhD; Denise Owensby, BS, CCRP; Debary Bell, BS; Michael Wong, MD; Richard Perez, MD…

GOOD CLINICAL PRACTICES GOOD CLINICAL PRACTICES DR. KARUN KUMAR JUNIOR RESIDENT – I DEPT. OF PHARMACOLOGY What is Clinical Research ? Research conducted on Human subjects…