Hi Kari,
I have been looking for something similar, and am actually attending a course next month, DIA's Drug Safety and Pharmacovigilance Across the Product Lifecycle. It is offered again two times later this year.
It looks like it will provide a great foundation in PV principles, practices, and requirements. it is focused on US and EU regulations, but the basic principles apply across all territories.
I am currently working thru the on-line course pre-work, and it has been extremely valuable.
I can give you an update after I complete the course in April. :)
DIA also has several e-learning safety and PV training modules that you might find useful.
Hope this helps!
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Susan Shockey RAC
Regulatory Affairs and Quality Management
Charleston SC
United States
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Original Message:
Sent: 12-Mar-2019 17:35
From: Kari Frantzen
Subject: Pharmacovigilance Training Recommendations
Hello RAPS Community,
Looking for recommendations for worth-while pharmacovigilance training courses or webinars for myself (Quality/Regulatory Manager) and our Qualified Healthcare Professional in response to a recent Health Canada PV inspection observation. We both have experience, primarily in the clinical trial realm, however our training records weren't sufficient for the inspector and need updating.
Requirements:
- Reasonably priced in North America (we are a government-funded healthcare institution)
- Reasonable in length, especially for my Qualified Healthcare Professional who has a lot on the go (e.g. 1 - 2 day in-person course, also open to a good quality webinar)
- Canadian perspective appreciated (we manufacture niche product for the Canadian market)
Thanks!
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Kari Frantzen MBA, BSc
Quality Manager
Vancouver BC
Canada
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