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11:00 AM — 12:30 PM
1:30 PM — 3:30 PM
4:00 PM — 6:00 PM
9:00 AM — 9:45 AM
9:45 AM — 10:30 PM
11:00 AM — 12:30 PM
1:30 PM — 3:30 PM
4:00 PM — 5:45 PM
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11:00 AM — 12:00 PM
1:00 PM — 4:00 PM
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Concepts of Electronic Transmission of ICSRs, Introduction to EudraVigilance,Registration with EudraVigilance, Clinical Safety Data Management and Transmission of ICSRs - ICH E2B(R2)
EudraVigilance Gateway and WEB Trader, ICSR Validation Business Rules
Creating a Safety Message
Follow-up Report, Nullification Report, Literature Report
Parent-child Report
Report with Medical and Drug History
Study Report, EudraVigilance Business Rules, Saving and Printing Options
Receiving Acknowledgment Messages, Validation and Creating Acknowledgments
WEB Trader - Post Function, What To Do in the Event of System Failure
MedDRA Simple and Advanced Queries, ICSR Simple and Advanced Queries
Questions and review for Knowledge evaluation
Knowledge Evaluation: Multiple Choice and ICSR Exam Case