What is GVP ? What are Good Pharmacovigilance Practices (GVP) ? |💊 PV360 | Learn PV for Free |

Learn about the different workflows involved in case processing of ICSR in Pharmacovigilance.

💊 Pharmacovigilance 360 - 👉 Subscribe Now 👈

💊 Pharmacovigilance is pharmacological science relating to detection, assessment and prevention of adverse effects of drugs. Improving drug safety is a task concerning not only regulatory authorities and pharmaceutical industry but also prescribing physicians. This is done right from the drug research and development stage to post marketing drug surveillance.

💊 This Channel intends to provide you all the information that you need to crack the Pharmacovigilance interview by providing you basic understanding of the concepts such as:

👉Introduction, History & Overview of Pharmacovigilance
👉Drug Development and Clinical Trial Phases
👉Pharmacovigilance Process & Life cycle
👉Introduction and responsibilities: USFDA, EMA and CDSCO
👉Clinical Development process
👉Different phases of clinical Trials
👉Adverse events and its types
👉Drug Safety in clinical trials and post marketed drugs
👉Different sources of Adverse events reporting
👉Different types of AE reporting Forms
👉Expedited reporting and its timelines
👉Different departments working on Pharmacovigilance
👉Roles and responsibilities of case receipt unit
👉Roles and responsibilities of Triage unit
👉Four factors for the reportable case
👉Seriousness criteria of adverse event
👉Expectedness or Listedness of adverse event
👉Causality assessment of the adverse event
👉Introduction to safety database and different types
👉Narrative writing
👉Case quality check, Medical review and its submission.
👉PSUR and its submission timelines
👉Aggregate reporting Overview
👉Signal Management Overview& many more!