CERTIFICATE PROGRAM IN SIGNAL DETECTION & RISK MANAGEMENT

1. Certificate Program in Signal Detection & Risk Management – Online Mode – eLearning Mode – Virtual Classroom
* Live Audio Video Sessions using GoToMeeting / Zoom
* 24x7 Content Learning Management System Access
*Session recording to be uploaded in cLMS
*Training on Oracle Empirica
*Hands on Access to Safety database – Safetyeasy AB CUBE
Certification – Program Accredited from Accreditation Council for Clinical Research Education, United States of America & Pharmaceutical Society of India.
There will be around 15 Live Sessions. This training course will review approaches to the implementation of signal detection and data mining as part of your pharmacovigilance operations. The requirement for companies to perform signal detection is mandatory in Europe and highly recommended in the US. Many simple techniques can be applied to the generation and review of potential signals, which can also be augmented by the application of sophisticated data mining algorithms.

Key Topics :
1. Background to Signal Detection
2. Legalities
3. Signal Detection Objectives & Key Components
4. Signalling Analyses
5. Data Mining Examples
6. Information Component (IC)
7. Sources of Signals
8. Signal Management Databases
9. Signal Management Processes
a. Signal Detection
b. Signal Validation and Prioritisation
c. Signal Assessment
10. Recommendation for Action
11. Communication
12. Summary and Quality Check
We do not Mention “online” on Certificates