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…

1. Presented byPaul Below, CCRA, CCRT P. Below Consulting, Inc. Conducting Studies to theInternational Gold StandardGoing Beyond What the FDA Requires 2. Learning Objectives•…

1. BY- ANUBHAV SINGH M.PHARM 1st Year IPR, GLA UNIVERSITY 2. It is a standard for clinical studies or trials that encompasses the design, conduct, monitoring, termination,…

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 1GCP for Emergency Medicine Slide 2  This presentation is intended for emergency physicians involved in recruiting patients to clinical trials and/or caring for…

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…