ISPE Mid-Year Meeting
Saturday, April 1 - Tuesday, April 4 , 2017
Royal College of Physicians
London, U.K.
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33rd ICPE
Wednesday, August 23 � Sunday, August 27, 2017
Halifax Convention Centre, Halifax, Nova Scotia, Canada
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December 1, 2016
The Latin America Chapter will host an upcoming webinar titled "Recomendaciones Para Escribir Resúmenes Efectivos de Conferencias Para Hablantes Nativos de Español," presented by Dr. Rene Soria-Saucedo on Wednesday December 14, 2016 from 9:00 AM – 10:00 AM (ET).

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 24, 2016
The FDA is inviting interested parties to participate in a workshop entitled, "Substitutability of Generic Drugs: Perception and Reality". Hosted by Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JHU-CERSI) and the Food and Drug Administration (Center for Drug Evaluation and Research, and Office of Chief Scientists's Office of Regulatory Science and Innovation), the workshop is open to the public and may be of particular interest to external researchers, generic drug pharmaceutical industry representatives/scientists, generic drug policy makers, physicians and patients.  For additional information, and to view the agenda and register, please visit the conference webpage.

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.

October 6, 2016
The petition for the formation of a new Oncology SIG was approved at the August 2016 Board meeting in Dublin. If you are interested in joining Oncology SIG, please email the co-chairs Wei Zhou and Al Artaman.

September 30, 2016
The 2017 Mid-Year Meeting Call for Abstracts is open! Visit our meeting website for information on the abstract process for the meeting. The deadline for abstract submission is November 17, 2016.