Monday, January 25, 2021

Latest Pharma news

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 Biomakers?

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

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...

COVAX Announces new agreement, plans for first deliveries

January 22, 2021: COVAX, the global initiative to ensure rapid and equitable access to COVID-19 vaccines for all countries, regardless of income...

FDA Approves OPDIVO® with CABOMETYX® as First-line Treatment for advanced Renal Cell Carcinoma

22 Jan 2021:  Bristol Myers Squibb announced that OPDIVO®(nivolumab) 240 mg (injection for intravenous use) every two weeks or 480 mg every four weeks...

FDA granted approval of Cabenuva and Vocabria to ViiV Healthcare for HIV

January 21, 2021: "The U.S. FDA approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human...

Pfizer, BioNTech’s COVID-19 vaccine Results are likely to be effective against UK strain

January 20, 2021: "Pfizer Inc. and BioNTechSE announced results f rom an in vitro study that provides additional data on the capability of sera...

Merck’s VERQUVO Approved for Cardiovascular Death and Heart Failure

January 20, 2021: "Merck, known as MSD outside the United States and Canada, today announced that the U.S. FDA has approved VERQUVO,...

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...

NHS patients to benefit from first full access deal in Europe for new CAR-T therapy recommended by NICE

January 19, 2021: "NHS patients are to be among the first in the world to be offered access to a cutting-edge cancer...

Enhertu approved in EU for HER2-positive metastatic breast cancer

January 20, 2021: "AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has been granted conditional approval in the European Union (EU)...

ViiV Healthcare and Chelsea and Westminster Hospital continues HIV care parternership

January 18, 2021: "ViiV Healthcare and Chelsea and Westminster Hospital NHS Foundation Trust are continuing their innovative partnership to transform HIV patient...

More than 4 million people receive first dose of COVID-19 vaccine in UK

January 19, 2021: "More than 4 million people in the UK have received their first dose of a COVID-19 vaccine as part...

Novartis and GSK announce collaboration to support scientific research into genetic diversity in Africa

January 19, 2021: "Novartis and GSK today announced the launch of a collaboration to support high-quality scientific research investigating the link between...

Other

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...

What Is a Blockbuster Drug?

What Is a Blockbuster Drug? "Blockbuster drugs are those that generate at least $1 billion of revenue per...

Covaxin: Everything that you should know

Covaxin is an investigational vaccine candidate for COVID19. It is in Phase III clinical trial as of today (20-Dec-2020). It is being...