UPCOMING MEETINGS

ISPE Mid-Year Meeting
Saturday, April 1 - Tuesday, April 4 , 2017
Royal College of Physicians
London, U.K.
Click here for more information.

33rd ICPE
Saturday, August 26 - Wednesday, August 30, 2017
Palais de Congres de Montreal
Montreal, Canada
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10th Asian Conference on Pharmacoepidemiology
Sunday, October 29 - Tuesday, October 31, 2017
Brisbane, Australia
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EuroDURG 2017
Wednesday, November 15 - Friday, November 17, 2017
Glasgow, Scotland
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Click here to view ISPE's meetings and events

ISPE UPDATES

ISPE Statement on the March for Science
The International Society for Pharmacoepidemiology (ISPE) and its members are dedicated to advancing public health, and as part of that mission advocate for valid evidence on drug safety and effectiveness, and its positive effect on public health. ISPE is non-partisan; however, its members are public health advocates in their own countries across the world. While ISPE will not endorse or participate as an organization in the March for Science, or any local marches on April 22, ISPE encourages its members to participate in public health debates and serve as a voice for the specialty in the public sphere.

February 16, 2017
Call for Abstracts - Deadline June 16, 2017. Make your plans to attend ISPE's 10th Asian Conference on Pharmacoepidemiology (ACPE) will be held October 29-31 in Brisbane, Australia. Click here for more information. Abstract deadline - June 16, 2017

February 16, 2017
The 33rd ICPE call for abstracts is closed. Information on your abstract's status will be available in May 2017

February 14, 2017
The ISPE Board of Directors 2017 Election is underway. Click here to vote in the election if you are an ISPE member. If you want to submit a paper ballot, you can download it here. The deadline for voting is March 7, 2017.

January 23, 2017
ISPE is pleased to announce that the 33rd International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE) will take place in Montreal, Canada from Saturday, August 26 - Wednesday, August 30, 2017 at the Palais de Congres de Montreal.

January 4, 2017
The Bordeaux Pharmacoepi team is happy to announce the Sixth Bordeaux Pharmacoepidemiology Festival . From May 10-12, six world-class experts will talk of the topic of their choice at the Bordeaux University School of Law in Pace Bey-Berland, Bordeaux.

For more information on the European regulatory system for medicines, please consult our brochure or visit http://www.pharmacoepi.eu/.

November 23, 2016
The European Medicines Agency has released for public consultation a draft guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.
This is the first revision of the 'Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products'. The revision is intended to further assist sponsors in the transition from non-clinical to early clinical development and identifies factors influencing risk for new investigational medicinal products. The document includes considerations on quality aspects, non-clinical and clinical testing strategies and designs for first-in-human clinical trials (CTs) and early phase CTs. Strategies for mitigating and managing risks are given, including principles on the calculation of the starting dose to be used in humans, the subsequent dose escalation, the criteria for maximum dose and the conduct of the CT including the conduct of multiple parts.
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 FIH-rev@ema.europa.eu.

Please note that the deadline for comments is 28 February 2017.

For more information on the European regulatory system for medicines, please consult our brochure.