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Pharmacovigilance Module 1
About Drug Discovery. Part 1
History of Drug Discovery. Part 2
CRO and Sponsor Responsibilities Part 3
Monitor Responsibilities Part 4
History of Clinical Research Part 5
Pharmacovigilance Module 2
Problems Due to Inadequate PV System Part 1
Active Ingredients Withdrawn Part 2
Pharmacovigilance Definition Part 3
Pharmacovigilance Aim & Responsbilites Part 4
Lifecycle of Drug and Pharmacovigilance Part 5
Need of Pharmacovigilance Even After Clinical Trials. Part 6
Do Pharmacovigilance Needed in Every Country. Part 7
Term & Definitions Part 8
Term & Definitions Part 9
Partners in Pharmacovigilance Part 10
Drug Regulatory Authorities Part 11
Pharmacovigilance Help & Rational. Part 12
What to Report. Part 13
History of Pharmacovigilance Evolution Part 14
Pharmacovigilance Module 3
Principle Part 1
Principle Part 2
Sources of AE Reports Part 3
Sources of AE Reports Part 4
Pharmacovigilance Module 4
Timeline for ADR Reporting Part 1
ICSR Report Part 2
Form FDA Part 3
ICSR Case Processing Workflow Part 4
Receive Case Report Sources Part 5
Safety Data Processing Part 6
Receive Case Report Sources Part 7
Pharmacovigilance Module 5
Sources of ICRSs Part 1
Validity Criteria Part 2
Steps in Triage Activity Part 3
Steps in Triage Activity Part 4
Regulatory Timelines Part 5
Aggregate Reporting Part 6
Pharmacovigilance Module 6
Narrative Writting Part 1
Structure of A Narrative Part 2
Example Part 3
Introductory Paragraph Part 4
Follow Up Narrative Part 5
Follow Up Narrative Part 6
Narrative Writing Part 7
Why Need Regulation Part 8
Pharmacovigilance Module 7
Labelling of Drugs Part 1
Highlights for a Fictitious of Drug Part 2
Example Part 3
medDRA Process Flow Part 4
Pharmacovigilance Module 8
Re-Assessment of Follow Up Part 1
Example Part 2
Pharmacovigilance Module 9
Signal Management Part 1
Signal Management Part 2
Risk Management Part 3
Pharmacovigilance Module 10
WHO and ICSR Key Points on Signal Detection Part 1
Risk Managemeny Part 2
Coding in Pharmacovigilance Part 3
Drug Dictionary Part 4
Coding Using MedDRA Part 5
Pharmacovigilance Module 11
General Considerations Part 1
Safety Database Part 2
ARISg & ARGUS Part 3
Data Assessment Duplicate Check Part 4
Assessment of Class Once Saved in ARISg Part 5
Mandatory Field For Newcase Creation Part 6
Pharmacovigilance Module 12
Duplicate Check Part 1
Cases Part 2
Product Table Part 3
Pharmacovigilance Module 13
Product Table Part 1
Worklist Part 2