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

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 10, 2017
The "Call for Reviewers" has gone out at all ISPE members. Your email will come from a CTI Meetings address, so if you have not received one and you are an ISPE member, please check your spam filter. If you did not receive one you may need to renew your members - visit our Renew page for more information.

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/.

December 21, 2016
The 2017 ICPE Call for Abstracts is now open! Click here to view the guidelines and submit an abstract by the February 15, 2017 deadline.

December 7, 2016
The 2017 ICPE will NOT be held in Halifax, Nova Scotia. ISPE was notified that the Halifax Convention Centre that was scheduled to open in January 2017 will not be open in time for the 33rd ICPE on August 23-27. There is no suitable alternative in Halifax. ISPE staff are investigating alternatives and the website will be updated once additional information is available. Click here to view our press release.

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.

November 7, 2016
Congratulation to Dr.Hisham Aljadhey, Chair, ISPE Gulf Chapter, and Dean, College of Pharmacy, King Saud University, who has been appointed by the King of Saudi Arabia as the Commissioner of the Saudi Food and Drug Authority (SFDA)

October 26, 2016
The ISPE Nominations Committee is seeking nominees for election to the Society's Board of Directors. Listed below are the available positions:

  • President-Elect
  • Vice President, Finance-Elect
  • Industry/Service Provider - Asia/Pacific
  • Industry/Service Provider - Europe/Africa
  • Industry/Service Provider - Americas
  • Academic - Europe/Africa
  • Academic - Americas

The following are the criteria for consideration of nominees: constituency and geography; leadership in the field of pharmacoepidemiology; distinguished by special contributions to the Society; current in membership dues; five (5) years concurrent membership is desirable; and active involvement in the Society. ISPE members should submit their nominee suggestions to Sonia Hernandez-Diaz, FISPE, Chair of the Nominating Committee, and Mark Epstein, Executive Secretary, via email (shernan@hsph.harvard.edu; mepstein@paimgmt.com).  Any member interested in a self-nomination should submit to Sonia Hernandez-Diaz, FISPE, and Mark Epstein (shernan@hsph.harvard.edu; mepstein@paimgmt.com) the following: a 2-4 paragraph biography, a vision statement for the Society, and a digital photo.

<

October 19, 2016
The 2017 ISPE Call for Fellows is open. The ISPE Board of Directors has created a special elected category of membership for its outstanding leadership. Fellowship Status is awarded upon election as Fellow by the Board on the recommendation of a committee of peers (the Fellowship & Awards Committee). Elected members are designated 'ISPE Fellows' (FISPE). 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.
For eligibility, application requirements, and more, visit our Fellows application website.