The Advanced Training Workshop on Pharmacovigilance 2018 is dedicated to pharmacovigilance activities in pharma industry.
Topics
- Drug Safety Physician Functions
- Evaluation of causality for Adverse Drug Reactions
- Education of healthcare practitioners
- Grading and Analysis of Human System involvement
- Coding of Adverse Events as per MedDRA
- Narrative writing for outcome of the Adverse Events
- Drug Safety Department
- Case Processing, Reports, and Transmission
- Data Entry, Case Generation Units
- Quantity-Statistical Review Functions
- Quality Medical Review Functions
- Pharmacovigilance, SOP, REMS: Action Units
- Reports
- ISSR (Integrated Summary of Safety Reports)
- ICSR (Individual Case Safety Reports)
- Aggregate reports
- Expedited and SUSAR reports
- PBRER (Periodic Benefit Risk Evaluation Reports)
- Regulatory Compliance for Drug Safety and Pharmacovigilance
- Good Pharmacovigilance Practices- Global Perspective
- WHO and ICH (CIOMS/FDA/EU initiatives)
- ICH-CDISC-Compliant Data Submission
- Global Regulatory Compliance
- FDA-Audit/inspection/Approval/withdrawals
- Informatics in Pharmacovigilance & Introduction to Oracle Argus Safety Application
- Drug safety Technology Vendors
- Emerging Computer based tools for Pharmacovigilance
- Various Data Mining tools
- ARIS GLOBAL Total Safety Suite
- Case processing and discussions on types of cases, case processing in Argus software, quality standards for accurate detection and analysis of drug safety signals
- Training on the features of Argus Safety
- Signal Detection
- Signal identification
- JMP
- Data visualization
- Signal analysis and management
- Regulatory compliance
- Signal analytics with advanced statistical formulae
- Risk benefit analysis methods in Pharmacovigilance
- SRP / Things taken into account while issuing safety alert or label warning - IC values and interpretation
- Methods of risk benefit analysis in Pharmacovigilance(Trade off metric Indices - INHB, BRR, UT-NNT, GBR, Principal of Threes, TURBO, Beckmann)
Who should Attend
Attendees involved or interested in pharmacovigilance.
