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The Quick explanation on investigators brochure used in Clinical Trial/Research by the principal inv...
The Investigator's Brochure (IB) is a crucial document in the realm of clinical research and dru...
Medical device regulation is complex, in part because of the wide variety of items that are categori...
A clinical trial is a culmination of the several stages of a drug or medical device development prog...
FDA regulation for medical devices, U.S regulations
In Japan, the pharmaceutical industry operates under strict regulatory oversight by the Pharmaceutic...
In this slide share we will learn about investigation use of drugs.
describe about role of sponsor and CRO on clinical trial process
COMBINATION PRODUCT THAT CONSIST COMBINATION OF MEDICAL DEVICE WITH DRUG, DRUG WITH BOILOGICAL PRODU...
Investigational Product: procurement, storage, labeling procedures is included in this presentation.
Pharmacovigilance slides with details on Medical Devices and PV Agreements set-up in Clinical studie...
A document outlining trial objectives, design, methodology, and analysis plan.��It serves as a r...
Regulation For Combination of products & medical devices
INVESTGATIONAL NEW DRUG APPLICATIONS
A clinical investigation is defined as “any systematic investigation or study in one or more human...
regulatory affairs
regulation of combination medicine and medical devices
SAE data reconciliation The process of comparing key safety data variables between the drug or devic...
Contents Guidelines for Preparation of Documentation Clinical Study Reports Clinical Trial Monitorin...
clinical trail documentation
Working on Clinical Trials – Getting started Very few clinical trials are conducted only in one c...
In these slides you can get the information of clinical trials which have four phase I,II,III, IV. b...
“CSR is a detailed regulatory document which gives the information about the methods and results (...
Clinical Research and Pharmacovigilance
