1. VOLUME: 16 - ISSUE: JUL 2015 | PHARMA UPTODAY 2. PHARMA UPTODAY 2 Inside this issue 3 News Uptoday 59 New Guidance 72 Audit Findings 483 Observations EU Non Compliance…

Julia Lee, Pharm.D. Regulatory Support Branch Division of Labeling and Program Support (FDA│CDER│OGD) A Filing Reviewer’s Perspective on Electronically Submitted Documents…

Slide 1Life Sciences Life Sciences Industry Trends and Update Bart Reitter, Director of Marketing – Life Sciences QAD West Coast User Group November 2014 Slide 2 Life Sciences…

Slide 1Evaluating Change in Hazard in Clinical Trials With Time-to-Event Safety Endpoints Rafia Bhore, PhD Statistical Scientist, Novartis Email: [email protected]…

Slide 1 Webinar Hosted by Pharmaceutical Manufacturing Wednesday, November 7 2012 Presented by Hedley Rees, Biotech PharmaFlow Slide 2 Agenda What is behind the ‘supply…

Slide 1 Risk Assessments: Patient Safety and Innovation Innovation Discussion 18 July 2013 Slide 2 FDASIA Group Charter – The Food and Drug Administration Safety and Innovation…

Slide 1 Beyond regulatory submission - Standards Metadata Management Kevin Lee CDISC NJ Meeting at 06/17/2015 We help our Clients deliver better outcomes, so they can improve…

Slide 1 DRAFT FDASIA Committee Report David W. Bates MD, MSc, Chair 1 Slide 2 Committee Membership David W. Bates, Chair, Brigham and Women’s Hospital Patricia Brennan,…

Risk and Innovation Risk Assessments: Patient Safety and Innovation 28 June 2013 Committee Members David Bates, Chair, Brigham and Womenâs Hospital â¢Patricia Brennan,…

Slide 1 DRAFT FDASIA Committee Report David W. Bates MD, MSc, Chair 1 1 Committee Membership David W. Bates, Chair, Brigham and Womenâs Hospital Patricia Brennan, University…