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July 2013

26 Jul 2013 ISPE Seeks Leaders for Europe and Asia Pacific Operations
26 Jul 2013 Nobel Laureate Dr. Oliver Smithies to Deliver Plenary Session at ISPE Biotechnology Symposium
24 Jul 2013 ISPE invites Members to comment on four WHO draft guidance documents
10 Jul 2013 ISPE invites Members to comment on US FDA Draft Guidance “Expedited Programs for Serious Conditions”

 

June 2013

12 Jun 2013 Study Reveals Multiple Root Causes for Drug Shortages
10 Jun 2013 ISPE Patient Initiative Issues Survey Regarding Patient Experience with Clinical Trial Materials
04 Jun 2013 ISPE invites Members to comment on FDA Draft Guidance Contract Manufacturing Arrangements: Quality Agreements

 

May 2013

20 May 2013 ISPE invites Members to comment on Revisions to EU GMP Chapters 3, 5, 6, and 8
16 May 2013 ISPE Names Barbara A. Myers, CAE, as Vice President of Professional Development
13 May 2013 PMMI and ISPE Partner to Launch Pharma EXPO
06 May 2013 Pharma Expo Announcement

 

April 2013

19 Apr 2013 ISPE invites Members to comment on EMA draft Guideline on Exposure Limits in Shared Facilities
16 Apr 2013 Second ISPE-FDA Event Attracts Top Names, Features Release of Drug Shortage Survey Results
05 Apr 2013 ISPE invites Members to comment on two EMA draft Guidelines: GDP for API and Risk Assessment for Excipients
04 Apr 2013 ISPEAK, April 2013: Midwest Chapter News  Members only
03 Apr 2013 ISPE Releases New Guidance for Booklet Labels in Global Clinical Trials

 

March 2013

13 Mar 2013 Deadline Approaches for ISPE Drug Shortage Survey
07 Mar 2013 ISPE Conference to Benchmark and Advance Quality by Design in the Biopharmaceutical Industry

 

February 2013

14 Feb 2013 ISPE Issues Drug Shortage Survey
06 Feb 2013 ISPE Releases New Guidance for Definition and Use of Non-Investigational Medicinal Products in Clinical Trials

 

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