Thursday, October 22, 2020

Latest Pharma news

Clinical data management

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"

How to resolve reference ranges issue in RAVE eDC- CRA, CRC and DM prospective.

Whether you are a Clinical Research Associate (CRA), Clinical Research Coordinator (CRC) or a Clinical Data Manager (CDM), you all face...

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

What is Pharmacovigilance? Pharmacovigilance has been defined by the World Health Organisation (WHO) as “The science and activities...

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

AZ’s Tagrisso scores priority review from FDA with EGFR-mutated lung cancer

October 20, 2020: "AstraZeneca’s Tagrisso (osimertinib) has received acceptance for its supplemental New Drug Application (sNDA) and has also been granted Priority Review in...

Forxiga recommended for approval in the EU by CHMP for heart failure

October 19, 2020: "AstraZeneca’s Forxiga (dapagliflozin) has been recommended for an indication extension of its marketing authorisation in the European Union (EU) for the...

AstraZeneca advances leadership in renal disease at ASN Kidney Week 2020 Reimagined

October 20, 2020: AstraZeneca will present 84 abstracts, including 12 oral presentations and three late-breaking abstracts, across its industry-leading renal portfolio which...

AbbVie’s VENCLEXTA® Receives FDA Approval for Acute Myeloid Leukemia

October 16, 2020: "AbbVie announced that the U.S. Food and Drug Administration (FDA) has provided full approval to VENCLEXTA® (venetoclax) in combination...

Pharmacovigilance Interview Questions 2020

What is Pharmacovigilance? Pharmacovigilance has been defined by the World Health Organisation (WHO) as “The science and activities...

CHMP recommends approval of Dupixent® for children with severe atopic dermatitis

October 16, 2020 – "The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent® (dupilumab),...

Novartis receives positive CHMP opinion for Leqvio® for the treatment of high cholesterol

October 16, 2020:"Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive opinion and...

Roche signs deal with Dyno Therapeutics for gene therapy vectors

October 14, 2020: "Dyno Therapeutics, a biotech company applying artificial intelligence (AI) to gene therapy, announced a collaboration and license agreement with...

NIHR publishes dynamic themed review into ‘ongoing COVID’

October 15, 2020: "The National Institute for Health Research Centre for Engagement and Dissemination has today published its first dynamic themed review of the...

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...

RPS calls for action to fight counterfeit medicines

October 13, 2020: The Royal Pharmaceutical Society of Great Britain (RPS) has called on the UK government to take immediate action to...

Vir Biotechnology and GSK announce global expansion to Phase 3 of COMET-ICE study

October 06, 2020: "Vir Biotechnology, Inc. and GlaxoSmithKline plc announced the global expansion to Phase 3 of the COMET-ICE (COVID-19 Monoclonal antibody...

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.

List of Best free articles to read about structure, tests, treatment and Pathogenesis about COVID19

We have reviewed many articles by doing a secondary search in google and found that below-mentioned articles are quite informative and freely...