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UPCOMING MEETINGS

30th Anniversary ICPE
October 24-27, 2014
Taipei International Convention Center
Early Bird Deadline - August 14

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ISPE UPDATES

July 18, 2014
The early bird deadline to register for the 30th ICPE is fast approaching. Be sure to register by August 14th to get the lowest rates possible for the meeting. Register today!

July 17, 2014
ISPE Academic Council Committee Meeting — July 22 at 10am EDT/3pm BST. Click here for additional information.

July 17, 2014
SISPE presents a webinar on July 23, 2014 at 11am EDT US / 5pm CEST — Is there an observational analog to a placebo group? Click here for additional information.

July 14, 2014
Call for Manuscripts Deadline Extended — ISPE seeks proposals for one or more manuscripts to address the "Value and role of non-interventional pharmacoepidemiology studies in establishing evidence about the real-world benefits and harms of medical treatments." Papers are welcomed that show the complementary role of pharmacoepidemiology with randomized trials; additional weight will be given to papers that provide examples and/or quantitative support to illustrate the value or complementary value of observational research. Deadline extended to Tuesday, July 22, 2014.

July 2, 2014
Call for Comments — Closed. Thank you to those who provided comments to the ISPE BRACE SIG draft paper entitled "Benefit-Risk Assessment, Communication and Evaluation (BRACE) throughout the Life Cycle of Therapeutic Products: Overall Perspective and Role of the Pharmacoepidemiologist."

June 19, 2014
The European Medicines Agency has released a concept paper on the draft European Union individual case safety report (ICSR) implementation guide for public consultation. The document open for consultation is available by clicking here. Comments should be provided using this template. The completed comments form should be sent to eu-ig-icsr@ema.europa.eu. The deadline for comments for this concept paper is June 30,2014.

June 19, 2014
The European Medicines Agency has released, for public consultation, a draft best practice guidance for pilot European Medicines Agency health technology assessment parallel scientific advice procedures. The document open for consultation is available by clicking here. Please see the following link for consultation questions: https://adobeformscentral.com/?f=WIJldoXFmz7BsTWjUwOiDA. The deadline for responses for this best practice guidance is July 14, 2014.

June 19, 2014
The EMA's Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines (such as those taken by mouth but not topical medicines like creams and gels). The press release is available by clicking here.

June 19, 2014
The European Medicines Agency has released for public consultation a draft detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency. The document open for consultation is available by clicking here. Comments should be provided using this template. The completed comments form should be sent to mlm@ema.europa.eu.

June 13, 2014
Call for Comments –The ISPE BRACE SIG is requesting member comments for its draft paper entitled “Benefit-Risk Assessment, Communication and Evaluation (BRACE) throughout the Life Cycle of Therapeutic Products: Overall Perspective and Role of the Pharmacoepidemiologist.” The purpose of this paper is to describe practical applications of pharmacoepidemiology in BRACE activities to support the optimization of evidence-based benefit-risk profiles for therapeutic products. This is the first of a series of papers on BRACE activities; subsequent papers will aim to address other specific topics on this subject. DEADLINE TO COMMENT: July 1, 2014. Click here to login and comment.

May 28, 2014
ICPE 2014 Abstract Update- Coe-Truman (ISPE's abstract processor) has begun emailing notifications about abstract presentations for ICPE 2014 to submitters. If you have not received an email by Friday, May 30th please contact Coe-Truman Support via email at c4asupport@coetruman.com

May 27, 2014
Renew your ISPE membership for 2014-2015 today. Click here to login and renew.

May 27, 2014
Registration for the 2014 ICPE, taking place October 24-27 at the Taipei International Convention Center, is now open. Click here to register. Early bird deadline: August 14, 2014 at 11:59pmEST (US).

May 14, 2014
EMA seek comments on Draft guideline on the investigation of subgroups in confirmatory clinical trials; deadline July 31, 2014. Click here for additional information.

May 7, 2014
ISPE Academic Council Committee Meeting - May 22 at 10am EDT/3pm BST. Click here for additional information.

May 6, 2014
ISPE seeks manuscripts, from members, to address the "Value and role of non-interventional pharmacoepidemiology studies in establishing evidence about the real-world benefits and harms of medical treatments." Click here for more information and to submit your manuscript. Deadline: Tuesday, July 15, 2014 | 11:59pm CDT USA.