Home
About ISOP-Israel
How to be a member
Meetings
About ISOP
Useful links
Contact us
News

ISoP 2019
3-4 June 2019, Daniel Hotel, Herzliya, Israel

ISoP 2013
1-4 October 2013, Pisa, Italy
Save money and register before 15 July! Abstracts submission is now closed

TOPRA - ISoP conference: Practical Application of Benefit-Risk Management
23 September 2013, Brussels, Belgium

ISoP Asia 2013 Symposium:
Singapore, 19-21 March 2013 (report)

ISoP 2012
30 Oct - 2 November 2012, Cancun, Mexico

ISoP GA Cancun - Thursday 1 November 2012: Cancun GA minutes are now available (with new elected ISoP Executive Committee and Officers)

20% discount on Oxford University Press for all ISoP members

Welcome to the South Eastern European Chapter!

ISoP Women's Medicines Group

ISoP is on LinkedIn (Members section)

The ENCePP Guide on Methodological Standards in Pharmacoepidemiology

EU Regulatory workshop on Medication Errors
28 February and 1 March 2013

Meeting report published on EMA website

20% discount on Wiley-Blackwell Pharmacology and Pharmaceutical Medicine books for all ISoP members

Drug Safety journal: issue Table of contents

 

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!

  Proposed program as follow

 

  The New PSUR/PBRER
Irene Fermont

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