Black triangle products In the European Union (EU), medicines that are being monitored closely by regulatory authorities are labelled with a black inverted triangle (▼) in the product information. These medicines are described as being under ‘additional monitoring’. Medicines under additional monitoring carry a black triangle symbol (an inverted equilateral black triangle; ▼) to let patients and Health Care …
Regulatory Authorities in Pharmacovigilance A regulatory authority is an autonomous enforcing body created by the government to oversee and enforce regulations regarding occupational health and safety. Regulatory Authorities play a vital role to meet the requirements of legal procedures related to drug development process in a country. The regulatory body ensures compliances in various legal and …
Introduction EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and monitoring the safety of human medicines. It constitutes experts in medicines safety from regulatory authorities in Member States, scientific experts and representatives of patients and healthcare professionals, which are nominated by the European Commission. EMA supports the PRAC by providing data from clinical practice available in electronic …
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Hello Pharmacovigilance Professionals and Pharmacovigilance Aspirants, If you are a fresher or just started your career in Pharmacovigilance (PV) then you must have a lot of queries regarding what are different roles in PV jobs? Which Pharmacovigilance Job Role is High demanding? Which Pharmacovigilance Job Role provides High Salary packages? Pharmacovigilance Job First of all, lets see what are the overall …
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The Development safety update report (DSUR) is pre-marketing periodic report which covers safety information of drugs, biological, vaccines and combo products under development (including marketed drugs that are under further study) among the ICH regions. Development Safety Update Report (DSUR) DIBD (Development International Birth Date) DIBD is the date of first approval (or authorisation) …
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Dear All, We have published an eBOOK for frequently asked Questions and Answers in Clinical Data Management (CDM) interview. E-Book for Clinical Data Management (CDM) Interview preparation The purpose of this eBook is to help freshers CDM aspirants and experienced CDM professionals in their interview preparation. This eBook will be helpful to understand basic concepts of Clinical Data …
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Dear PV Professionals and PV Aspirants, Today we will see some basic facts about PADER (Periodic Adverse Drug Experience Report). What is PADER? A PADER is a type of aggregate safety report required to be submitted by a sponsor or marketing authorization holder (MAH) to the US Food and Drug Administration (FDA) after obtaining marketing authorization approval. PADER …
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Hello All, Hope you are enjoying our articles on Pharmacovigilance and Drug Safety related topics. Today we will discuss in brief about Qualitative and Quantitative signal detection in Pharmacovigilance. Signal detection in Pharmacovigilance Signal A Signal is an “information that arises from one or multiple sources (including observations and experiments), which suggests a new potentially causal …
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How to find Pharmacovigilance Job? or How to get Pharmacovigilance Job? This is the most commonly asked questions from Pharma, Life sciences and Medical professional freshers. This question is very common to both Freshers and Experienced candidates that how to know about pharmacovigilance (PV) job openings. How to find Pharmacovigilance Job in year 2022? Finding PV …
Hello All, We hope this Year 2021 was challenging as well as hopeful for you. New Year 2022 is on the way and we know you Freshers are already doing hard to get your first job. There are incredible Job Opportunities in Clinical Research Industry and we are very sure that there are abundance of …
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