Pharmacovigilance Course

Course Curriculum

Chapter 1: Pharmacovigilance Module 1

Lecture 1: About Drug Discovery. Part 1

Lecture 2: History of Drug Discovery. Part 2

Lecture 3: CRO and Sponsor Responsibilities Part 3

Lecture 4: Monitor Responsibilities Part 4

Lecture 5: History of Clinical Research Part 5

Chapter 2: Pharmacovigilance Module 2

Lecture 1: Problems Due to Inadequate PV System Part 1

Lecture 2: Active Ingredients Withdrawn Part 2

Lecture 3: Pharmacovigilance Definition Part 3

Lecture 4: Pharmacovigilance Aim & Responsbilites Part 4

Lecture 5: Lifecycle of Drug and Pharmacovigilance Part 5

Lecture 6: Need of Pharmacovigilance Even After Clinical Trials. Part 6

Lecture 7: Do Pharmacovigilance Needed in Every Country. Part 7

Lecture 8: Term & Definitions Part 8

Lecture 9: Term & Definitions Part 9

Lecture 10: Partners in Pharmacovigilance Part 10

Lecture 11: Drug Regulatory Authorities Part 11

Lecture 12: Pharmacovigilance Help & Rational. Part 12

Lecture 13: What to Report. Part 13

Lecture 14: History of Pharmacovigilance Evolution Part 14

Chapter 3: Pharmacovigilance Module 3

Lecture 1: Principle Part 1

Lecture 2: Principle Part 2

Lecture 3: Sources of AE Reports Part 3

Lecture 4: Sources of AE Reports Part 4

Chapter 4: Pharmacovigilance Module 4

Lecture 1: Timeline for ADR Reporting Part 1

Lecture 2: ICSR Report Part 2

Lecture 3: Form FDA Part 3

Lecture 4: ICSR Case Processing Workflow Part 4

Lecture 5: Receive Case Report Sources Part 5

Lecture 6: Safety Data Processing Part 6

Lecture 7: Receive Case Report Sources Part 7

Chapter 5: Pharmacovigilance Module 5

Lecture 1: Sources of ICRSs Part 1

Lecture 2: Validity Criteria Part 2

Lecture 3: Steps in Triage Activity Part 3

Lecture 4: Steps in Triage Activity Part 4

Lecture 5: Regulatory Timelines Part 5

Lecture 6: Aggregate Reporting Part 6

Chapter 6: Pharmacovigilance Module 6

Lecture 1: Narrative Writing Part 1

Lecture 2: Structure of A Narrative Part 2

Lecture 3: Example Part 3

Lecture 4: Introductory Paragraph Part 4

Lecture 5: Follow Up Narrative Part 5

Lecture 6: Follow Up Narrative Part 6

Lecture 7: Narrative Writing Part 7

Lecture 8: Why Need Regulation Part 8

Chapter 7: Pharmacovigilance Module 7

Lecture 1: Labelling of Drugs Part 1

Lecture 2: Highlights for a Fictitious of Drug Part 2

Lecture 3: Example Part 3

Lecture 4: medDRA Process Flow Part 4

Chapter 8: Pharmacovigilance Module 8

Lecture 1: Re-Assessment of Follow Up Part 1

Lecture 2: Example Part 2

Chapter 9: Pharmacovigilance Module 9

Lecture 1: Signal Management Part 1

Lecture 2: Signal Management Part 2

Lecture 3: Risk Management Part 3

Chapter 10: Pharmacovigilance Module 10

Lecture 1: WHO and ICSR Key Points on Signal Detection Part 1

Lecture 2: Risk Managemeny Part 2

Lecture 3: Coding in Pharmacovigilance Part 3

Lecture 4: Drug Dictionary Part 4

Lecture 5: Coding Using MedDRA Part 5

Chapter 11: Pharmacovigilance Module 11

Lecture 1: General Considerations Part 1

Lecture 2: Safety Database Part 2

Lecture 3: ARISg & ARGUS Part 3

Lecture 4: Data Assessment Duplicate Check Part 4

Lecture 5: Assessment of Class Once Saved in ARISg Part 5

Lecture 6: Mandatory Field For Newcase Creation Part 6

Chapter 12: Pharmacovigilance Module 12

Lecture 1: Duplicate Check Part 1

Lecture 2: Cases Part 2

Lecture 3: Product Table Part 3

Chapter 13: Pharmacovigilance Module 13

Lecture 1: Product Table Part 1

Lecture 2: Worklist Part 2