Wednesday, April 21, 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...

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),...

Introductory Session on Clinical Data Management

Hello everyone, Introductory Session on Clinical Data Management for Freshers is going to be held on Aug-30-2020 (Sunday)...

Institutional Review Board

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

Free Course on Clinical Data Management

Freshers and job seekers  often search for clinical data management courses and they are ready to pay a good amount but this...

Basics of case report form

"Case report form (CRF) is designed to collect the patient data in a clinical trial as per the clinical trial protocol"

CLINICAL RESEARCH

Terminologies of Clinical trial terms

Adverse Event "A undesirable change or medical occurrence that occurs during a clinical trial or within a certain time...

What are Cancer biomarkers?

"Cancer biomarkers (CB) are biomolecules produced in response to the tumour by either the tumour cells or other cells within the body....

What are Biomarkers? What are the types of Biomarkers?

According to the National Cancer Institute, a biomarker is “a biological molecule found in blood, other body fluids, or tissues that is a...

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...

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scientific writing

Difference Between Medical Writing and Scientific Writing

There are different views on using these two terms- medical writing and safety writing. Hence we tried to put some light on...

Impact Factor

Since a long time, Impact factor (IF) has been used as a key indicator of importance of a journal in a...

Let’s learn how to write an ABSTRACT

What you need to include in a research paper is ABSTRACT: ...

Lets learn how can You summarize any Story/ article or Research Paper

What is summarizing: Giving a short statement of the important points by removing all extra fat. Why is it important: It allows...

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)....

Two days Crash-Course on Pharmacovigilance

Specially designed Course for Freshers and entry Level Professionals on Pharmacovigilance is going to be held On 10 Oct (Saturday): 04:00-06:00pm and...

Development Safety Update Report (DSUR)

"DSURs are new, globally harmonised safety documents (which became obligatory in the Member States of the European Union in September 2011) covering...

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) ...

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...

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...

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...

HEOR

centralized monotoring

Centralized Monitoring in Clinical Trial

"The FDA definition of centralized monitoring states that it: "Consists of a remote evaluation performed by sponsor personnel or representatives (e.g., clinical...

Clinical researh associate

Investigator Meeting: Planning to Success

"An Investigator Meeting is typically the responsibility of a sponsor, but this role can also be assigned to a CRO. For those...

Clinical Research Associate: Role, Responsibilities, Skills, and Salary

Introduction: Clinical Research Associate may be employed directly by the sponsor companies of clinical trials or by ...

clinical coding

What is Medical Coding?

"Medical coding is the transformation into necessary medical alphanumeric codes of healthcare diagnoses, treatments, medical facilities, and supplies. The...

LATEST ARTICLES

Chemotherapy-free treatment option to be offered to patients with England’s most common leukaemia

April 21, 2021: A brand new oral treatment for an incurable blood cancer has been recommended for NHS use by NICE.

GW Pharma receives EU approval for EPIDYOLEX® for treatment of seizures

April 20, 2021: "GW Pharmaceuticals, a world leader in discovering, developing and delivering regulatory approved cannabis-based medicinesannounces that the European Commission has...

Amgen Successfully Completes Acquisition Of Five Prime Therapeutics

April 16, 2021: "Amgen announced that it has successfully completed its previously announced tender offer to purchase all outstanding shares of...

JCVI issues new advice on COVID-19 vaccination for pregnant women

April 16, 2021: There have been no specific safety concerns identified with any brand of coronavirus (COVID-19) vaccines in relation to pregnancy. 

Phico Therapeutics gains £13.1m grant to advance antibacterial therapy

March 19, 2021: "Phico Therapeutics Ltd, a biotechnology companydeveloping engineered phage technology as the basis of a new generation of antibiotics to...

EU approves second indication of Sarclisa® for relapsed multiple myeloma

April 19 2021: "The European Commission approved Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone (Kd) for the treatment of adult patients with...

AstraZeneca receives US clearance of proposed acquisition of Alexion

April 16, 2021: "AstraZeneca’s proposed acquisition of Alexion Pharmaceuticals, Inc (Alexion) has achieved an important step toward completion, having cleared US Federal Trade...

Update of the WHO guidance on the treatment of drug susceptible tuberculosis

April 16, 2021: The WHO is convening a Guideline Development Group (GDG) to advise on updates needed to its recommendations on the...

FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab

April 16, 2021: "The U.S. FDA revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone,...

FDA Approves First Immunotherapy for Initial Treatment of Gastric Cancer

April 16, 2021:The U.S. Food and Drug Administration approved Opdivo (nivolumab), in combination with certain types of chemotherapy, for the initial treatment...

Alchemab raises £60M A financing to advance novel platform

Apr 15, 2021: "Alchemab Therapeutics, a biotech company developing novel products for patients with hard-to-treat diseases by harnessing the power of naturally...

Amylyx Pharmaceuticals provides global regulatory update on amx0035 for ALS

April 14, 2021: Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer’s Disease and...

Other

GPAT 2021-Results-Announcement

 The National Testing Agency (NTA) has announced GPAT (Graduate Pharmacy Aptitude Test) 2021 on 19-Mar-2021 and you can access the result at below...

Tools Used in Writing Thesis and Research paper

"If you are a student or a researcher or a scholar, then you should use some tools that will help you focus...

What is the process for Submission of Synopsis?

1.1 a. "Prior to submission of a thesis synopsis, a comprehensive assessment of the research work should be carried out by a...

What Is a Synopsis? What is the Process for Submission of Synopsis?

"A synopsis is a brief summary that gives audiences an idea of what a composition is all about. The...