21/01/2015 Other Services
Covalent is a group of company which has services and operations in Clinical, Information Technology, Energy, consumer products, Power and Infrastructure.
Training @ Covalent:-
We arededicated to establish ourselves as ''A values-driven organization''. These values will continue to direct our growth and organization’s operation. “Covalent” values supporting the way like “Kreative”.
Pharmacovigilance Training / Course/ Training Institute:-
Module I Pharmacovigilance
Basic principles of Pharmacovigilance in Clinical Trials
Methodologies for Pharmacovigilance
Module II Regulations in Pharmacovigilance in Clinical Research
FDA and EU perspectives
Drug Regulatory Activities MedDRA
Regulatory Aspects in Pharmacovigilance
Regulations in Pharmacovigilance in Clinical Research
Module III Adverse Drug Reactions and Safety Reports
Causality Assessment of Suspected Adverse Drugs Reactions
Periodic Safety Update Reports (PSURs) For Marketed Drugs (ICH E2C)
Expedited Reporting Requirements
Individual case safety reports
Periodic safety update reports
Electronic safety reporting
WHO & safety monitoring
Module IV Signal Analysis
Definition of signal and type of signal
Conducting signal detection in clinical and post marketing surveillance
Defining signal in relation to risk/benefit
Signal generation to decision making
Signal Detection Tools
Understanding signals & benefit risk determinations
Module V Compliance to Clinical Safety and Pharmacovigilance Regulations
Training Duration (Classroom/Online): 3-Months/2-Months
Training Fee: 20K/25k
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