PrimeVigilance announces their next webinar which will be co-hosted by Pharmafocus and features speaker Ivana Sutalo, a Senior PV Project Manager and Deputy QPPV. This session takes place on Tuesday 7 November, 2017 starting at 3pm GMT (UK), 4pm CET (Europe), 10am EDT (US) at which time Ivana will be providing an overview of “EudraVigilance changes and their impact on MAHs”, followed by a live Q&A session.

Key topics covered in this webinar include:

• simplified EV reporting requirements
• EV Access levels for MAHs
• non-serious cases
• downloading/processing ICSRs from EV
• increases in workload?
• importance of prompt updates to XEVMPD
• E2B R3 format – challenges of conversion
• changes to MLM case management
• which EVWEB registration status to choose
• SDEAs

Finally, she will outline some challenges of E2B (R3) conversions and pragmatic processing of all source data that is made available in E2B (R3) format in a safety database which operates with E2B (R2) format, and highlight the key considerations that can help streamline the process and meet the regulatory (GVP VI) requirements.

Ivana will also be available at the end to answer any questions you may have, offering you the benefit of her knowledge and experience.

Click here to book your place today. If you require further information, please do not hesitate to contact us.

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