HOT TOPICS IN PV
Hot Topics in PV is a cycle which started in 2 January 2014. The principle is a short meeting of 2 to 3 hours, hosted by voluntaries, presented by professionals, every two months. The presentations will be posted on ISOP ISRAEL website. A general presentation of the subject with practical examples is followed by questions and round table.
Volunteers are most welcome for :
- Hosting the HOT TOPICS
- Proposing new topics
- Performing the presentation
We have been successful enough to gather 50 people , then 75 people. Just plan enough space!
Dear Fellows and Colleagues,
Following the EU new regulation and the 2012 Good Pharmacovigilance Practices Module 7, ICH has revised an in-depth PSUR (Periodic Safety Update meeting) format and content, renaming it PBRER - the Periodic Benefit Risk Evaluation Report. The new PBRER has thus been endorsed by main ICH members: FDA, EMA and Japanese Drug Agency (PMDA).
In parallel, the Israeli Ministry of Health requires the industry to submit a summary of the PSUR signed by the QPPV /QP, stating if there are new safety concerns and what actions should to be taken to maintain the best benefit risk balance.
In the framework of HOT TOPICS IN PV program, and following the successful 1st meeting - attended by 50 professionals - we are pleased to invite you to the second session, that will be a joint meeting with The Pharmaceutical Society of Israel :
The new PSUR /PBRER
Presented by :
Dr Irene Fermont, IFC Safety Consulting, founder
Objectives :
- Presentation (1-1:15 hours):
Highlight of the main changes in format and content of the PSUR/PBRER in the ICH guideline and EU regulation
- Case study (1-1:15 hours)
1- what to look for in the summary for the Israeli MOH? 2- organise your process, collect your data, set up your timeline Q&A session and open discussion
When: 9 March 2014, 16:00 – 19:00
Where: "The Council for a Beautiful Israel" conference center, 80 Rokach Blvd., Hayarkon Park, Tel Aviv. Paid parking is at the park's entrance.
Registration: The Pharmaceutical Society of Israel has kindly agreed to host free of charge 25 ISOP ISRAEL members, who are not their members. Register early to benefit from this invitation.
Registration is mandatory (via email: Shifra@bioforum.co.il) |
Our Mission:
ISOP (International Society of Pharmacovigilance) has welcomed the creation of an Israeli Chapter to spread Pharmacovigilance education and training for all stakeholders : industry, academy, authorities, healthcare professionals and patients.
We look forward to welcoming you at this 2nd meeting and the following ones. The full proposed HOT TOPICS IN PV program is attached as well as the ISOP ISRAEL Vision
On behalf of ISOP ISRAEL Advisory Board
Dr Irene Fermont MD, MSc., EUQPPV, ISOP ISRAEL Coordinator
Yehudith Wexler, MSc., Educational Program Advisor
& Ram Malis, Pharmacists in the Industry Forum
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