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October 2013

31 Oct 2013 ISPE Named as a Source in FDA Strategic Plan for Preventing and Mitigating Drug Shortages
22 Oct 2013 ISPE to Engage Members, Industry Leaders and Regulators in Critical Dialogue on Breakthrough Therapies at 2013 ISPE Annual Meeting
07 Oct 2013 Pharmaceutical Quality Metrics Conversation to Continue at 2013 ISPE Annual Meeting
04 Oct 2013 US Government Shutdown Postpones ISPE Proactive Compliance Conference

 

September 2013

17 Sep 2013 ISPE invites Members to comment on ICH Guideline for Elemental Impurities Q3D
17 Sep 2013 ISPE invites Members to comment on EU GMPs Annex 16 - Certification by a Qualified Person and Batch Release

 

July 2013

26 Jul 2013 ISPE Seeks Leaders for Europe and Asia Pacific Operations   324 KB
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24 Jul 2013 ISPE invites Members to comment on four WHO draft guidance documents
10 Jul 2013 ISPE invites Members to comment on US FDA Draft Guidance “Expedited Programs for Serious Conditions”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04 Jun 2013 ISPE invites Members to comment on FDA Draft Guidance Contract Manufacturing Arrangements: Quality Agreements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

 

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