What you'll learn
DSUR( Development Safety Update Report)
SCS, ISS and 120 day safety update report
Risk evaluation and management
PBRER and PADER
Other post marketing reports and Internal reports
Teams involved in safety writing and sample case study
Case study- Case summary analysis sample
Requirements
Basic level of English
Good quality of internet connection
Desktop /Laptop/Smartphone required(Since dealing with online mode)
Basic Knowledge on medical field
Description
About Course:Pharmacovigilance medical safety writing is most important process in every stage of drug development, approval and post marketing phase. This process require highly skilled people with clear understanding of regulation and guidelines as the reports should be very accurate and should be submitted as per timelines. PV medical safety writers are the most demanding professionals in PV sector due to the requirements from the authorities.Main responsibilities of PV medical safety writers:Writing periodic safety summary reports including collection, analyzing, preparing line listings, summary tabulations, drafting safety evaluationsChecking the format and content as per regulatory standardsCourse Modules:IntroductionTypes of Pharmacovigilance documentsPre-market : DSURMarketing Authorization phase: SCS, ISS, Risk evaluation and management documents, 120 day safety update reportsPost Authorization: PBRERs, PADERs, ADHOC safety review, ACO, PSUR addendum, Summary Bridging reports.Teams involved in preparing the documentsSample case studyTRAINING RECOGNITION & ACCEPTANCEWHO Pharmacovigilance GuidelinesInternational Conference on HarmonizationGood Pharmacovigilance Practices ModulesThe preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting the document, coordinating the input of the involved functions, providing valuable expertise on the required format and contents and detailed guideline knowledge, and coordinating the review and consolidation of comments. Furthermore, different submission scenarios and document requirements exist, depending upon, for example, the medicinal product, therapeutic indication, and authorization procedure. The result should always be a high quality state-of-the-art document meeting all requirements for an electronic submission to health authorities worldwide.
Overview
Section 1: Demo class
Lecture 1 Demo class of " Pharmacovigilance medical safety writing"
Section 2: Complete Course
Lecture 2 DSUR( Development Safety Update Report)
Lecture 3 SCS, ISS and 120 day safety update report
Lecture 4 Risk evaluation and management
Lecture 5 PBRER and PADER
Lecture 6 Other post marketing reports and Internal reports
Lecture 7 Teams involved in safety writing and sample case study
Lecture 8 Case study- Case summary analysis sample
Graduate or postgraduate degree in Pharmacy or Pharmaceutical Sciences,Graduate or postgraduate degree in Medicine,Graduate or postgraduate degree in Chemistry (subject) .,Pharmacovigilance early experience candidates


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