3rd Annual ISPE-FDA CGMP Conference to Address Latest Compliance Trends and Clarify Regulatory Expectations

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FOR IMMEDIATE RELEASE

Contact:
Danielle Hould
ISPE Marketing Communications Manager
Tel: +1-813-960-2105, ext. 277
Fax: +1 813.264.2816
dhould@ispe.org
www.ISPE.org

3rd Annual ISPE-FDA CGMP Conference to Address 
Latest Compliance Trends and Clarify Regulatory Expectations

(TAMPA, FLORIDA, USA, 30 January 2014) – Top officials from the US FDA will meet with ISPE Members and other pharmaceutical industry leaders to discuss compliance trends and identify practical solutions for modern quality systems, technology transfer, metrics implementation and other relevant topics during the third annual ISPE-FDA CGMP Conference, taking place 2 – 4 June in Baltimore, Md. USA. The conference will explore industry hot topics in an ongoing conversation between ISPE Members and FDA to advance contemporary methods of ensuring a reliable supply of medicines. During the event, ISPE will also report on its Drug Shortages initiative.

“This annual ISPE-FDA event is well positioned to address recent comments by FDA Commissioner Margaret Hamburg around the criticality of maintaining a reliable drug supply and harmonization of global regulatory perspectives which are priorities for regulators and industry alike,” said Nancy Berg, ISPE President and CEO. “The ISPE-FDA CGMP Conference is the ideal setting for addressing critical issues related to product quality and manufacturing readiness, with an agenda developed jointly by FDA and ISPE that emphasizes focused, productive and solution-driven dialogue designed to move the industry forward.”

Dr. Janet Woodcock, Director, CDER, FDA, will be one of the plenary speakers for the event. Dr. Woodcock’s remarks at the inaugural CGMP Conference in 2012 set the tone for much of the regulatory-industry collaboration that has occurred since the inception of this signature event. It is expected that her statements at this year’s event will include an update on the FDA’s Office of Pharmaceutical Quality and implementing and measuring a culture of quality. Pfizer VP, Global Quality Operations Mary Oates, PhD and AstraZeneca Executive Vice President David Smith will also present at the plenary session.

Conference content has been developed by a program committee comprised of senior leaders from both FDA and ISPE, including:

  • Mike Arnold, Senior Director, Strategic Partnerships, Pfizer Global Clinical Supplies, USA
  • Paul D’Eramo, Vice President, Pharmaceutical Regulatory Compliance, Johnson & Johnson, USA
  • David Doleski, Director, Division of DGMPA, FDA
  • Joe Famulare, Vice President, Global Compliance, Genentech Inc., USA
  • Rick Friedman, Associate Director, Office of Manufacturing & Product Quality, FDA
  • Brian Hasselbalch, Consumer Safety Officer, CDER, FDA
  • Charles Hoiberg, Executive Director, Pfizer Inc., USA
  • Tim Howard, Vice President, Global Operations, Commissioning Agents, Inc., USA
  • Steve Lynn, Director, Office of Manufacturing and Product Quality, FDA
  • George Millili, Senior Principal Technical Advisor, Genentech Inc., USA
  • Mike Smedley, Deputy Director, Office of Compliance, FDA

Sessions, case studies and workshops will focus on new and emerging trends in compliance; development, pre-approval and technology transfer; end-to-end process control; metrics implementation; combination products; breakthrough therapies; and practical solutions to drug shortages.

Complete details of the event, including program and registration information, are available at www.ISPE.org/2014-CGMP-Conference. To obtain media credentials to cover the event, please contact ISPE Manager, Marketing Communications Danielle Hould at dhould@ispe.org.

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA and offices in Shanghai, China and Frankfurt, Germany. Visit www.ISPE.org for more information.
 

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