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.

Click here to view ISPE's meetings and events

ISPE UPDATES

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.

February 7, 2017
A writing group of Industry Council members has developed a white paper that reviews the value of epidemiology throughout the product development and commercialization life cycle. The Council is seeking comments from the ISPE membership. Click here to read the manuscript and provide your comments. Simply click on the text where you want to make a comment and provide your comments in the box. You first must submit your email address at the top of the page before you can enter your comments. The deadline for comments is February 21, 2017 at 5:00 PM ET U.S.

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 20, 2017
The ISPE call for Fellows is open. Consideration for election to Fellowship is open to those members who are recognized as having leadership roles in pharmacoepidemiology and who are held in high professional standing. View the requirements and criteria here. The deadline to submit application materials is February 22, 2017.

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.