PHARMACOVIGILANCE SCIENTIST TRAINING
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ACI- Pharmacovigilance Training Specialist
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This “Qualified Pharmacovigilance Professional” training program aim to create Pharmacovigilance professionals by covering all the technical aspects of Pharmacovigilance job. The program includes 12 weeks of extensive training incorporate the
unique technicalities and experience combined from our extensive team of industry professionals. The technical training on case processing with live experience on the Pharmacovigilance project gives the opportunity for candidates to excel in their Pharmacovigilance
career.
TRAINING RECOGNIATION & ACCEPTANCE
- WHO Pharmacovigilance Guidelines
- International Conference on Harmonization
- Good Pharmacovigilance Practices Modules
TAKE AWAYS
- Training completion certificate
- Recommendation letter for candidates with good performance in training
Outline
“BASIC & REGULATORY ASPECTS OF PHARMACOVIGILANCE “
- Introduction & History of Pharmacovigilance
- Pharmacovigilance complete Process
- Pharmacovigilance Terminologies
- Introduction & origin of Pharmacovigilance Guidelines
- Regulatory authorities – Worldwide
- International Conference on Harmonization (ICH)
- Guideline on good Pharmacovigilance practices (GVP)
- FDA 21 CFR Part 11
“SOURCES & PROCESSING OF ICSRS“
- ationale for Pharmacovigilance Monitoring
- Safety in the Lifecycle of Products
- PRE-MARKETING SAFETY ASSESSMENT
- POST-MARKETING SURVEILLANCE
- POST-MARKETING SURVEILLANCE METHODS
- ICSR PROCESSING
- Date of receipt
- Case validity
- Seriousness assessment
- Expectedness determination
- Case Follow-up Approaches
- Causality assessment
- Narrative writing
- Special Case Scenarios
- Case Nullification
- Record retention
- ICH E2B ICSR Transmission – Data Elements
“ICSRs PROCESSING WITH SAFETY DATABASE & MEDDRA CODING“
- Introduction to safety databases
- Case Processing in E2B Compliance Safety Database
- MedDRA v20.0
- Scope, Introduction, Definition, Maintenance, Rationale
- MedDRA Applications
- Structure of MedDRA
- MedDRA Conventions
- Coding Guidelines
- MedDRA Important Medical Events (IME)
- MedDRA for Aggregate Data Output
- Change Request Information
- The MSSO Change Request Process
- MedDRA Version updates
“REGULATORY REPORTING IN PHARMACOVIGILANCE“
- Expedited reporting
- Aggregate Reporting
- PSUR
- PBRERs
- ADCO
- DSURs
- Signal Detection & Assessments
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ACI is a globally recognized, Pharmacovigilance Training Management Company primarily focused on creating qualified pharmacovigilance professionals through our high quality and Industry recognized trainings. ACI has been instituted to cater to the growing demand for ‘skilled professionals', essentially addressing the gaps that exists between what an educational institution teaches and what an organization requires.
Since its foundation in 2013, ACI is a leading Professional Training company located in Chandigarh, specializes in Pharmacovigilance training. ACI has been dedicated to create Pharmacovigilance Professionals through technical training program from a fresher to corporate level.
Our programs are customized as per the global regulatory and industry standards with a progressive approach to ensure that the Pharmacovigilance trainings are imparted with focus on creating Pharmacovigilance professionals.
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