Sunday, July 25, 2021

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Clinical data management

CRASH COURSE ON CLINICAL DATA MANAGEMENT

Specially designed Course for Freshers and entry Level Professionals on Clinical Data Management  is going to be held 29 Nov (Sunday) from 10:00 A.M-12:30...

Interview Questions on Institutional Review Board(IRB)

“The Institutional Review Board (IRB) also known as an Independent Ethics Committee (IEC), Ethical Review Board (ERB), or Research Ethics Board (REB), is a...

CLINICAL RESEARCH

Medical writing

Clinical Study Report

“A clinical study report (CSR) on a clinical trial is a document, typically very long, providing much detail about the methods and results of a trial. A...

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scientific writing

Pharmacovigilance

Pharmacovigilance Interview Questions 2020

We have written this blog especially for freshers after consulting many job aspirant who has experienced interviews in PV recently (in 2019-20). Also read:Clinical...

regulatory affairs

Drug Approval Process in China

The National Medical Products Administration (NMPA) ( Chinese name translation in English “State Drug Administration” or China Food and Drug Administration CFDA)  and the...

Approval pathways of Fixed dose combination (FDC) in India

Fixed dose combination (FDC) approval process is a little different from the drug approval process in India. ...

Drug Approval Process in India

Regulatory Bodies for Drug approval in India The Drug and Cosmetic Act 1940 and Rules 1945 was enacted to regulate the import, manufacture, distribution and...

Orphan Drug Designation in US, EU and Japan

Orphan Drug Designation in USA: There are two routes (criteria) for obtaining orphan designation of a drug and biologics for a rare disease or condition.Orphan...

The Drug approval process in EU:

50 regulatory authorities from the 31 European Economic Area (EEA) countries (28 EU Member States, including Iceland, Liechtenstein and Norway), the European Commission and EMA creates...
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centralized monotoring

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clinical coding

What is Medical Coding?

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