PhV beyond AE/ADR Reporting - Introduction

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Hi NetRUMians,Practically, the actual Pharmacovigilance activities begin only after all the Adverse Event reports are received by the company [Marketing Authorization Holder..(MAH)].In fact the company which markets the drug generally has the PhV liabilities rather than the actual manufacturer.

The various responsibilities include:1. Expedited reporting of Serious unexpected case-reports to all countries where the MAH (company) holds licence for marketing the product2. Mandatory Weekly literature Searches

3. Regular Submission of Aggregate safety reports - PSURs (Periodic Safety Update Reports)4. Signal Detection and Evaluation5. Updation of Product Information.6. Preparation for Regulatory Audits7. Responsibility towards Pharmacovigilance Agreements

We shall discuss about the above points, in detail, in the next few days.Regards,Manoj-- Dr.Manoj Swaminathan MBBS, MPH

Manager-Drug Safety & Risk Management,Lupin Ltd.Mob: 9869352840