Podcast
Questions and Answers
What is the primary responsibility of the Program Manager in ensuring the smooth implementation of the Program?
What is the primary responsibility of the Program Manager in ensuring the smooth implementation of the Program?
Who is responsible for receiving and making calls to patients to coordinate for assistance dispatches?
Who is responsible for receiving and making calls to patients to coordinate for assistance dispatches?
What is the frequency of the monthly refresher training organized by the Program Manager?
What is the frequency of the monthly refresher training organized by the Program Manager?
What is the role of TATA 1MG HSPL in the delivery of Novopen 4?
What is the role of TATA 1MG HSPL in the delivery of Novopen 4?
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What is the purpose of the AE reconciliation report prepared by the Program Manager?
What is the purpose of the AE reconciliation report prepared by the Program Manager?
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Who is responsible for ensuring the Status of AEs reported in a timely manner?
Who is responsible for ensuring the Status of AEs reported in a timely manner?
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Where should the AE form be shared?
Where should the AE form be shared?
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What is the timeline for submitting the AE form?
What is the timeline for submitting the AE form?
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What is the purpose of the RCA?
What is the purpose of the RCA?
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Who is responsible for collating incidents and presenting to the Client?
Who is responsible for collating incidents and presenting to the Client?
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When do TATA 1mg and Novo Nordisk Drug Safety unit reconcile all the AEs reported?
When do TATA 1mg and Novo Nordisk Drug Safety unit reconcile all the AEs reported?
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What is the format of the incident report?
What is the format of the incident report?
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Where are patient documents stored?
Where are patient documents stored?
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How long are patient documents retained?
How long are patient documents retained?
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Who is responsible for periodically reviewing and updating this document?
Who is responsible for periodically reviewing and updating this document?
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What is the primary purpose of the Safety Data Exchange Agreement?
What is the primary purpose of the Safety Data Exchange Agreement?
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What happens to patient documents after the retention period is complete?
What happens to patient documents after the retention period is complete?
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What is the purpose of the CAPA process?
What is the purpose of the CAPA process?
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What is the primary purpose of the AE/PC reporting process?
What is the primary purpose of the AE/PC reporting process?
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Where are call records stored?
Where are call records stored?
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What is the purpose of the QC process?
What is the purpose of the QC process?
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Who is responsible for updating the document history?
Who is responsible for updating the document history?
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