Thursday, December 3, 2020

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

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...

What is Blinding in Clinical Trial?

As per National CancerInstitute: “A type of study in which the patients (single-blinded) or the patients and their doctors (double-blinded) do not...

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

FDA approves Xolair® (omalizumab) for adults with nasal polyps

December 01, 2020: "Roche announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application (sBLA)...

UK authorises Pfizer/BioNTech COVID-19 vaccine

December 02, 2020: "A Department of Health and Social Care spokesperson said: The government has accepted the recommendation from...

WHO Releases COVID-19 App for Trusted and Timely Updates

 December 01, 2020: The WHO has published a new mobile app to centralize the most trusted updates about COVID-19, and to guide...

First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer approved by FDA

December 01, 2020: The U.S. Food and Drug Administration approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for positron...

Eisai and Wren Therapeutics Enter Into Research Collaboration Agreement for Drug Discovery for Synucleinopathies

November 30, 2020: Eisai and Wren Therapeutics announced that the companies have entered into an exclusive research collaboration agreement aiming to advance...

AstraZeneca agreed to sell rights to Crestor to be divested to Grünenthal in Europe

December 01, 2020: AstraZeneca has agreed to sell the rights to Crestor (rosuvastatin) and associated medicines in over 30 countries in Europe, except the...

AstraZeneca’sForxiga approved in Japan for chronic heart failure

November 30, 2020: AstraZeneca’s Forxiga (dapagliflozin) has been approved in Japan for the treatment of patients with chronic heart failure (HF) who are receiving...

Moderna Announces the EC Approval for Initial 80 Million Doses of mRNA Vaccine Against COVID-19

November 25, 2020: "Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines...

BMS Receives EC Approval for Opdivo for Esophageal Squamous Cell Carcinoma

Nov 25, 2020: Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) for the treatment of adults with unresectable advanced, recurrent or...

Amgen To Transition Development And Commercial Rights to Cytokinetics

Nov. 23, 2020: Amgen announced the Company has provided notice to Cytokinetics of termination of its collaboration and its intention to transition the...

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...

Other

Interview with Kashish Gupta: NIPER 2020, AIR-36

NIPER is a well renowned institute that offers Master's degree after qualifying GPAT (Graduate Pharmacy Aptitude Test) and NIPER entrance test. NIPER...

What is Toxicokinetics?

"Toxicokinetics is basically the study of "how and what happens to a substance in the body" What is...

7 Steps to learn SAS quickly

Students often find SAS as a lucrative career opportunity. Good programming skills are needed to pass through the interview process.