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UPCOMING MEETINGS

ISPE Mid-Year Meeting
April 12-14, 2015
Bordeaux, France

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31st ICPE
August 22-26,2015
Hynes Convention Center
Boston, Massachusetts
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WHAT'S NEW

Educational Subscription: Members who have signed up for the ISPE Educational Subscription can now login and access content from selected Pre-Conference Courses and all three Plenary Sessions from the 30th ICPE in Taiwan. Additional content will be added next week. Thank you for your patience and we hope you enjoy the material! click here to login.

Interested in subscribing? Click here to sign up. Following successful registration, click on the link above to access the content.

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International Pharmacoepidemiology Legislation Map

ISPE UPDATES

December 16, 2014
Happy holidays! Access to the Educational Subscription has been extended through March 31, 2015. You can access the Education Module here. Still need to sign up? Click here.

December 16, 2014
On behalf of the ISPE Board of Directors and staff we wish you a happy holiday season and hope that 2015 will be a year of good health and success for you. Please note our holiday office schedule:
Dec. 24 - Closing at 3pm
Dec. 25 - Closed
Dec. 26 - Closing at 3pm
Dec. 31 - Closed
Jan. 1 - Closed
Jan. 2 - Closed

December 12, 2014
Abstracts for the 31st ICPE are now being accepted. Click here to view the abstract submission module. DEADLINE: February 16, 2015. The ICPE 2015 Scientific Program Committee offers a Newcomer Track for researchers submitting for the first time to the International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE), regardless of native language or country of origin. Click here for more information. The deadline for the Newcomer Track is January 15, 2015.

December 12, 2014
Join us on Wednesday, January 7, 2014 for a webinar The Secrets to Research Funding Success. The hour-long webinar will begin at 11amEST (US)/5pmGMT. Click here to join the webinar and add the event to your calendar.

December 12, 2014
Join us on Wednesday, February 18, 2014 for a webinar The Secrets to Building a Successful Research Team. The hour-long webinar will begin at 11amEST (US)/5pmGMT. Click here to join the webinar and add the event to your calendar.

November 25, 2014
The ISPE office will be closed Nov 26-30 for the Thanksgiving Holiday. It will reopen Monday, December 1.

November 7, 2014
The ISPE Nominations Committee is seeking nominees to stand for election for the following positions on the Boardof Directors and officer positions. Listed below are available positions:

Available Positions:
-Academic | Americas
-Academic | Europe/Africa
-Government-Regulatory | Asia-Pacific
-Government-Regulatory | Europe-Africa
-Government-Regulatory | Americas
-Vice President Finance-Elect
-President-Elect

Criteria:
-Constituency and geography
-Leader in the field of pharmacoepidemiology
-Distinguished by special contributions to the Society
-Current in membership dues
-Five years concurrent membership is desirable
-Actively involved in the Society

Any member interested in becoming a nominee should submit a short biography (2-4 paragraphs) and a vision statement for the Society to Til Stürmer, FISPE, Chair, Nominations Committee (sturmer@unc.edu).

November 6, 2014
Join us on Wednesday, November 12, 2014 for a webinar Enhancing Mentorship Experiences Across the Education Spectrum. The hour long webinar will begin at 11amEST (US)/5pmGMT. Click here to join the webinar and add the event to your calendar.

November 6, 2014
Certificates of attendance for the 2014 ICPE Meeting have been sent by email. If you did not receive a certificate please check your SPAM or Junk email folders before contacting the ISPE office at ispe@paimgmt.com.

November 3, 2014
Certificates of attendance for the 2014 ICPE Meeting will be sent later this week. Also, due to the large number of on-site registrations and requests, we are still in the process of emailing receipts. We appreciate your patience.

October 31, 2014
Educational Subscription: Members who have signed up for the ISPE Educational Subscription can now login and access content from the 2014 ICPE Pre-Conference Courses. Additional content will be added next week. Thank you for your patience and we hope you enjoy the material! To access the module, click here to login.

October 23, 2014
Pre-conference course presentations are posted on the meeting website and available for download here.

October 17, 2014
Want a sneak peek of the great programs offered in Taipei? Check out this special presentation webinar, previewing the plenary session, Using Patient-Centered Information in Pharmacoepidemiology: A Global Perspective, featuring Amy Abernethy, MD, PhD, an attending Oncologist at Duke University Hospital and CMO/SVP of Oncology for Flatiron Health. Can’t attend the 2014 ICPE? Register for the Educational Subscription, which offers 40+ hours of online education derived from the pre-ICPE courses, keynote sessions, and plenary sessions through December 31, 2014.

October 15, 2014
For those attending ICPE 2014, updated transportation information and maps have been posted here.

October 7, 2014
As of today, European citizens can obtain information on suspected side effects, also known as suspected adverse drug reactions, of an additional 1,700 active substances contained in medicines approved in the European Union (EU) through a website maintained by the European Medicines Agency (EMA), www.adrreports.eu. The press release is available by clicking here. The EMA has also published a leaflet in all official EU languages to encourage patients to report side effects. The leaflets are available by clicking here (EMA website) or here (ADR website).

September 19, 2014
ISPE's Latin America Chapter will host a webinar called Eficacia, efectividad y factores de confusion (Efficiency, effectiveness and confounding factors) on October 9, 2014 at 11amEDT. Presented by Rene Soria-Saucedo, the webinar will discuss the differences between the study of efficacy and the study of effectiveness are not always evident. This webinar will be presented in Spanish. Please click here for more information. Click here to join the webinar.

September 15, 2014
The European Medicines Agency has launched a public consultation on draft rules of procedures for public hearings held by its Pharmacovigilance Risk Assessment Committee (PRAC). The rules of procedure describe the process and practical arrangements for the preparation, conduct and follow-up of public hearings. You are kindly invited to review the proposed draft rules and send your comments to the 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 public-hearings@ema.europa.eu. Deadline: October 15, 2014.

September 11, 2014
The Faculty of Pharmaceutical Medicine of the Royal Colleges of the United Kingdom is currently developing a 'Code of Good Medical Practice in Pharmaceutical Medicine.' This document is based on the General Medical Council (UK) document, Good Medical Practice. They would like to hear the views of pharmaceutical physicians, fellow healthcare professionals, pharmaceutical companies, stakeholder organisations and members of the public on what is good about the current draft and where additions or edits could be made. Please find attached the draft version of Code of Good Medical Practice in Pharmaceutical Medicine (link to PDF) for your review. Any comments on the draft document should be sent directly to Ben Cottam using the attached pro-forma by 9am on Monday, 13th October 2014.

September 11, 2014
Advance online registration for the 2014 ICPE Meeting in Taipei is now closed. ISPE will accept onsite registrations at the meeting. Please click here to download the registration forms to bring with you to the meeting.

September 11, 2014
Membership renewals are now closed and accounts have been cancelled. Please contact ISPE by email (ispe@paimgmt.com) to reinstate your membership.

August 27, 2014
ISPE's renewal process has been extended. You now have until September 10 to renew your membership before your account is cancelled. Click here to renew.

August 20, 2014
The Council for International Organizations of Medical Sciences (CIOMS) announces the publication of Practical approaches to risk minimisation for medicinal products: Report of CIOMS Working Group IX. Please note that hard copies or electronic pdf files may be ordered by emailing in reply to info@cioms.ch using the order form or via CIOMS' website www.cioms.ch.

August 15, 2014
The Advance Registration Deadline is September 10th. Click here to register.

August 14, 2014
The Early Bird Deadline is today, August 14th. Register for the meeting by 11:59PMEDT in order to get the lowest available rate for the meeting. Click here to register.

August 14, 2014
The European Medicines Agency has released for open consultation a draft revision of EudraVigilance access policy for medicines for human use. The document open for consultation is available by clicking here. The comments should be sent to evaccess@ema.europa.eu. Please note that the deadline for comments for these documents is September 15, 2014.

August 8, 2014
Content from ISPE's Mid-Year Meeting in Rotterdam, The Netherlands is now available for members and attendees. Click here to view the content. Note, you will need a username and password to access course content.

August 7, 2014
Attention ICPE Scholarship Recipients: You must confirm your acceptance by registering for the meeting (using the form provided to you in your acceptance email) by August 14, 2014. If we do not hear from you by this date, the funds will be reallocated. There are no exceptions.

August 7, 2014
ISPE's Student Night Out Event during the 30th ICPE is sold out! To be added to a wait list please send an email to ispe@paimgmt.com.

August 6, 2014
Memberships will be made inactive on August 31, 2014. Renew today!

August 4, 2014
The FDA and NCI are hosting a public workshop to discuss methodologic issues relating to the study of cancer as a potential adverse effect of pharmaceutical therapies. The meeting is being held in Silver Spring, MD USA on September 10 and 11, 2014 and is free, but registration is required. A recent federal register notice, with more information, can be found here.

August 1, 2014
ISPE's official journal Pharmacoepidemiology and Drug Safety' had a significant increase to the Impact Factor which has risen from 2.897 to *3.172. A full report will be released soon.

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.