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Clinical data management

Clinical Data Management

CRASH COURSE ON CLINICAL DATA MANAGEMENT

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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...
Clinical Data Management

Interview Questions on Institutional Review Board(IRB)

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

Introductory Session on Clinical Data Management

Institutional Review Board

Free Course on Clinical Data Management

Basics of case report form

CLINICAL RESEARCH

Medical writing

Medical Writing

Clinical Study Report

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“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...

How to Become a Medical Writer in 2020

Medical writing Module 2: Epidemiology and Evidence-Based Medicine

Introduction to medical writing

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scientific writing

Pharmacovigilance

Pharmacovigilanc​e

Pharmacovigilance Interview Questions 2020

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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...

Two days Crash-Course on Pharmacovigilance

Development Safety Update Report (DSUR)

regulatory affairs

Drug Approval Process in China

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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

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

Drug Approval Process in India

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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

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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:

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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

Clinical researh associate

clinical coding

What is Medical Coding?

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