Clinical Safety and Pharmacovigilance

Community Chair

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Latest Discussion Posts

  • Thanks for responding Denise!  I realize my question might have been missing some context.  The question is specific to managing the info once it is already in the PV "workflow".  Once that happens, the PV process is usually quite rigid, it moves in one ...

  • Dear Fellow Pharmacovigilantes, I take great pleasure in wishing you and your near & dear a very Happy & Prosperous New Year 2020 ! I am delighted to share with you that I have been invited to deliver a speech titled " Post-Approval Pharmacovigilance ...

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  • Dear Dr. Li,  Will you please post the 2020 schedule to attend a demonstration of the 'I NTERACTIVE eDISH SAFETY GRAPHIC SOFTWARE PACKAGE: A NEW TOOL FOR IDENTIFYING AND INVESTIGATING SIGNALS OF HEPATOTOXICITY'? Thank you! Kind regards, Sharon Bathory ...

  • Gabapentin and pregabalin (Lyrica) are associated with serious breathing problems when used with CNS depressants or in patients with lung problems. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-serious-breathing-problems-seizure-and-nerve-pain-medicines-gabapentin-neurontin ...

  • Are you a medical /safety professional who works in a smaller-sized company where you may have less resources but you need to review your safety data? Are you a medical/safety professional where you wish you could change the endless listings into an ...

  • Hi All, Does anyone know of any resources/ presentations that summarise PV Inspection metrics in LMICs and African countries specifically? Tom ------------------------------ Tom Nichols Director Drive Phase PV London ------------------------------

  • Dear all, In early December there is a webinar to demo Veeva Vault Safety and Indegene's case processing automation software (ISS). Link is below if anyone is interested to register for the demo. https://www.indegene.com/webinar/webinar-on-pv-for-smb-in-pharma/ ...

  • What is your "success rate" in getting information on lot number from reporters? My experience is that lot number is often not available, but I'd like to hear from others.   Specifically, any bench marking data on success rates would be great.   Subjective ...

  • Dear Yi Jia, We are going to host another session on Dec 5, 2019. I hope you can make it then.  I will post the event soon, Best, Mengchun ------------------------------ Mengchun Li, M.D., MPA Core member of the DIA CSP community Director, Pharmacovigilance, ...

  • Hello CSP Members! If you're looking for opportunities to volunteer with DIA, please consider applying as a subject matter expert for the clinical safety and pharmacovigilance community! You can read more about the volunteer opportunity here . If you ...

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