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Pharmacovigilance Module 1
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About Drug Discovery. Part 1
5:00
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Preview
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History of Drug Discovery. Part 2
13:00
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CRO and Sponsor Responsibilities Part 3
7:00
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Monitor Responsibilities Part 4
16:00
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History of Clinical Research Part 5
37:00
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Pharmacovigilance Module 2
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Problems Due to Inadequate PV System Part 1
4:00
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Active Ingredients Withdrawn Part 2
2:00
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Pharmacovigilance Definition Part 3
4:00
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Pharmacovigilance Aim & Responsbilites Part 4
3:00
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Lifecycle of Drug and Pharmacovigilance Part 5
1:00
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Need of Pharmacovigilance Even After Clinical Trials. Part 6
4:00
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Do Pharmacovigilance Needed in Every Country. Part 7
1:00
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Term & Definitions Part 8
11:00
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Term & Definitions Part 9
3:00
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Partners in Pharmacovigilance Part 10
3:00
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Drug Regulatory Authorities Part 11
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Pharmacovigilance Help & Rational. Part 12
6:00
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What to Report. Part 13
1:00
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History of Pharmacovigilance Evolution Part 14
12:00
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Pharmacovigilance Module 3
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Principle Part 1
17:00
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Principle Part 2
3:00
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Sources of AE Reports Part 3
2:00
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Sources of AE Reports Part 4
5:00
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Pharmacovigilance Module 4
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Timeline for ADR Reporting Part 1
13:00
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ICSR Report Part 2
6:00
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Form FDA Part 3
2:00
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ICSR Case Processing Workflow Part 4
1:00
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Receive Case Report Sources Part 5
2:00
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Safety Data Processing Part 6
5:00
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Receive Case Report Sources Part 7
5:00
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Pharmacovigilance Module 5
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Sources of ICRSs Part 1
7:00
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Validity Criteria Part 2
7:00
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Steps in Triage Activity Part 3
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Steps in Triage Activity Part 4
20:00
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Regulatory Timelines Part 5
3:00
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Aggregate Reporting Part 6
19:00
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Pharmacovigilance Module 6
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Narrative Writting Part 1
9:00
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Structure of A Narrative Part 2
18:00
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Example Part 3
6:00
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Introductory Paragraph Part 4
2:00
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Follow Up Narrative Part 5
1:00
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Follow Up Narrative Part 6
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Narrative Writing Part 7
3:00
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Why Need Regulation Part 8
12:00
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Pharmacovigilance Module 7
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Labelling of Drugs Part 1
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Highlights for a Fictitious of Drug Part 2
5:00
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Example Part 3
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medDRA Process Flow Part 4
6:00
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Pharmacovigilance Module 8
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Re-Assessment of Follow Up Part 1
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Example Part 2
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Pharmacovigilance Module 9
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Signal Management Part 1
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Signal Management Part 2
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Risk Management Part 3
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Pharmacovigilance Module 10
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WHO and ICSR Key Points on Signal Detection Part 1
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Risk Managemeny Part 2
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Coding in Pharmacovigilance Part 3
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Drug Dictionary Part 4
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Coding Using MedDRA Part 5
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Pharmacovigilance Module 11
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General Considerations Part 1
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Safety Database Part 2
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ARISg & ARGUS Part 3
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Data Assessment Duplicate Check Part 4
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Assessment of Class Once Saved in ARISg Part 5
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Mandatory Field For Newcase Creation Part 6
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Pharmacovigilance Module 12
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Duplicate Check Part 1
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Cases Part 2
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Product Table Part 3
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Pharmacovigilance Module 13
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Product Table Part 1
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Worklist Part 2
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