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SERUDS to provide every child with the education and they deserves. They likes to study and they are...
1. Introduction During a new drug's early preclinical development, the sponsor's primary go...
Sponsor Responsibilities in clinical research as per ICH GCP E6
For better understanding of students. This will give you a detailed explanation of IND APPLICATION. ...
this ppt contains about 21 CFR part 312
INVESTIGATIONAL NEW DRUG APPLICATION AS PER FEDERAL FOOD DRUG AND COSMETIC ACT
This presentation provides an in-depth overview of the roles and responsibilities of various personn...
Investigational New Drug application
Presentation on Investigational New Drug (IND) enabling studies
intro, claasification , content and format, FDA review team, FDA approval process, etc
intoduction, classification, content and format, applications
Introduction to CONTRACT RESEARCH ORGANIZATION, Background, Over all view of CRO Presented by G.Ar...
IND
What is FDA Form 3454 for? Form FDA 3454, or the Financial Certification or Disclosure Statement, is...
An important body that overlooks the conduct of CT including safety issues
Schedule y
describe about role of sponsor and CRO on clinical trial process
drug development, IND, withdrawl of IND, exemption, IND review,
Investigational medicinal product dossier (IMPD) and Investigational brochure (IB) in Regulatory aff...
IND- Investigational New Drug
Investigator roles
Apllication Process and Marketing Authorization Process for Generics, IND, ANDA
Clinical trial and types
