1. All Professionals are involved in
Who can attend:
All Professionals are involved in
Pharmacovigilance (including QPPV) | Research | Risk Management | Drug Safety Assessment Department | Safety Data Analysis | Pharmacoepidemiology | Information Technology | Regulatory Affairs | Pharmacovigilance consultancy | Quality and Compliance | Legal
OnlineCompliancePanel LLC | Salmon Ter, Fremont California USA|

2. Processing Individual Case Safety Report (ICSR): workflow in Pharmacovigilance Industry
This webinar will describe how to process Individual case safety reports (ICSR) from different sources in pharmacovigilance operations from compliance, and safety perspectives. A structured methodology for case processing and reporting in drug safety operations will be presented. The webinar will also cover the process of adverse reporting for pre- and post-marketing cases including different steps like Case Intake, Case Processing, Medical Assessment and Distribution/Submission. This would be highly effective, as participants will get an opportunity to learn about case studies to manage a safety data crisis.
An Adverse Event for a drug could be generated during the drug development or post marketing phase. They could occur during the pre-clinical or clinical phase or be reported spontaneously by a doctor, nurse, pharmacist or consumer via phone, mail, fax, literature or the latest social media. As part of the case processing, safety data is gathered throughout the life of a product. Consequently, every pharmaceutical or pharmacovigilance company handling the safety cases of drugs across many countries collect thousands of reports per year. The only way to manage these ICSRs load is via a process flow that can effectively deliver the safety reports to regulatory authorities after the processing.
OnlineCompliancePanel LLC | Salmon Ter, Fremont California USA|

3. Interesting, right?
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