What Is Schedule Y. It is “Schedule under Part X-A of Drugs & Cosmetics Rule 1945 describe the information/data required –. Requirements and guidelines for
This ppt is describing basic structure of ICH-GCP & their differences and similarities to Indian Clinical trial guidelines – A free PowerPoint PPT presentation
in the context of research ethics vulnerable persons are those who are relatively or . The ICH GCP guideline states that the investigator is responsible for the
Clinical Trials: Current Regulatory Framework 1. Drugs and Cosmetics Act,1940 & Rules,1945; ICMR Ethical guidelines,2000/2006; Indian GCP Guidelines,
Agenda. Background. Guidelines. Informed consent procedures. Investigator responsibilities- GCP, protocol. Adverse Events. Qualification, Training, equipment.
These guidelines have been evolved with consideration of WHO, ICH, USFDA and presentation, verification, audit and inspection of the recorded data. A CRF
Unique joint effort by regulators and associated pharmaceutical industry trade associations; ICH guidelines have been adopted as law in several countries, butThis presentation provides core knowledge about ICH-GCP for emergency physicians ICH-GCP is Good Clinical Practice guidelines agreed at the conference.
Good Clinical Practice (GCP) guidelines was developed with consideration of Australia, . Indian clinical trials market is expected to grow at rate of nearly 36%
10 Apr 2016 INDIAN GCP (CDSCO Guidelines) Indian GCP PRESENTED BY: ANJALI RARICHAN FIRST YEAR M.PHARM . Indian gcp ppt cr by ann.