2014 ISPE CMO Conference

Conference Highlights

JOINT CGMP-CMO SESSION on DRUG SHORTAGES 
Wednesday, 4 June 2014  07.00 - 12.00

Begins with Breakfast with the Inspectors and closes with Industry-Regulatory Roundtable

Featured Regulators

  • Ernie Bizjak, Compliance Officer, FDA/ORA/OGROP
  • Rachel Harrington, Supervisory Consumer Safety Officer, FDA/ORA/OGROP
  • Sabine Haubenreisser, PhD, EMA-FDA Liaison, FDA/OC/OGROP/OIP
  • Gerald Heddell, Director, Inspection Enforcement and Standards Division, MHRA
  • Steve Lynn, Director, FDA/CDER/OC/OMPQ
  • Doug Throckmorton, M.D., Deputy Director, Regulatory Programs, FDA/CDER

INTERACTIVE WORKSHOPS 
Wednesday and Thursday, 4 - 5 June

Participate in a succession of four interactive workshops designed to address the most challenging components of the Owner-CMO partnership.

FDA Leaders are participating throughout the Workshops:

Mike Smedley
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Deputy Director, Office of Compliance, FDA/CDER/OC/OMPQ

Rick Friedman
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Associate Director of Manufacturing & Product Quality, FDA/CDER/OC/OMPQ

Paula Katz, JD
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Branch Chief (A), Regulatory Policy & Collaboration, FDA/CDER/OC/OMPQ

START-UP PHASE - Led by Courtney Billington, VP, Global Pharmaceutical Supply Chain, Johnson & Johnson
SELECTION PHASE -Facilitated by Jim Miller, President, PharmSource
GOVERNANCE - Led by Steve Leonard, Senior Vice President, Operations, Catalent
DELIVERY PHASE - Led by Wes Wheeler, CEO, Marken

Announcements:

MAKE SURE YOUR COMPANY'S VOICE IS HEARD!  

Discussions from the workshops will be collated for the development of a white paper to inform the development of guidance on this topic.

Featured KEYNOTE Speakers

Michael Levy, Senior Counsel, Compliance, FDA/CDER/OC

Courtney Billington, VP, Global Pharmaceutical Supply Chain, Johnson & Johnson

Steve Leonard, Sr. VP, Global Operations, Catalent Pharma Solutions

Thank you to our PROGRAM COMMITTEE!

Tim Tyson, Chairman and CEO, Aptuit, Inc. – Chair

Steve Leonard, Sr. VP, Global Operations, Catalent Pharma Solutions – Co-Chair

Paula Katz, Branch Chief (A), Regulatory Policy & Collaboration, FDA/OMPQ - Co-Chair

Courtney Billington, VP, Global Pharmaceutical Supply Chain, Johnson & Johnson - Co Chair

Joachim Del Boca, Apotheker, Vetter Pharma-Fertigung GmbH & Co KG