Pharmacovigilance (PV)
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Dear all,
We are pleased to announce that we have now agreed a date and venue for the proposed PV Workshop. The idea behind the workshop was originally conceived by the QA Group, however it is designed for those who act as the PV lead within their CTU whether or not they work in QA. Please forward this email to the most appropriate person in your CTU. Sessions have been planned to cover the following topics:
- Understanding the terms diagnosis, signs and symptoms; and investigations
- Assessment of causality and reviewing SAEs
- Assessment of expectedness and working with the RSI
- Managing RSI amendments
- Working through some real SAE examples
- Coding and the use of standard dictionaries.
Attendance at the meeting will be free however places are limited and will be allocated on a first come first served basis. Initially we will proceed on the basis of one place per CTU however we may allow more should there be capacity. Please note that registration is not yet open. A further email will be circulated as soon as it is. However, in the meantime, we would be grateful if you could also save the following details in your diary:
Date: 22 November 2016
Times: 10am to 4pm
Venue: Woodhouse Rooms, University House, University Rd, Leeds, West Yorkshire LS2 9JS
Regards
Louise
Louise Williams
UKCRC Registered CTU Network
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