20 Regulatory Speakers Confirmed for 3rd Annual ISPE-FDA CGMP Conference

May 08, 2014, 15:45 ET from ISPE

TAMPA, Fla., May 8, 2014 /PRNewswire-USNewswire/ -- ISPE announced today that it has confirmed 20 high-ranking regulators and 40 senior-level pharmaceutical leading speakers for the third annual ISPE-FDA CGMP Conference. The event, which takes place 2-4 June 2014 in Baltimore, Md., will bring together 400-plus attendees, regulatory and ISPE leaders for productive, solution-driven dialogue that will address critical questions and change related to ensuring pharmaceutical products are safe and reliable worldwide.

"Since the debut of the ISPE-FDA CGMP Conference in 2012, regulators and ISPE Members have acknowledged the event as the premier forum for collaboration and consensus-building around emerging regulatory trends impacting quality, data integrity and supply reliability, including quality systems, metrics, breakthrough therapies, and new views on combination products, just to name a few hot topics," said ISPE President and CEO Nancy Berg. "The impressive speaker line-up for the 2014 CGMP Conference is reflective of the event's reputation for paradigm-shifting discussion and an indication that the 2014 program will again exceed the high standards ISPE Members expect from this event."

Five plenary speakers have been confirmed for this year's event, representing leading-edge insights from FDA and industry:

  • Janet Woodcock, MD, Director, FDA/CDER: Bringing Manufacturing, Science and Quality to the Next Level
  • Mary Oates, PhD, VP, Global Quality Operations, Pfizer Inc.: Implementing and Measuring a Culture of Quality
  • David Smith, Executive Vice President, Global Operations and IS, AstraZeneca: Approaches in Assuring Reliable Supply from India
  • Ilisa Bernstein, PharmD, JD, Deputy Director, FDA/CDER: Global Supply and Emerging Markets
  • Gerald Heddell, Director, Inspection Enforcement and Standards Division, MHRA: European Perspective on Data Integrity

The conference will feature senior-level experts from Eli Lilly & Co., Genentech Inc., Pfizer Inc., Merck, GlaxoSmithKline, Commissioning Agents, Inc., Johnson & Johnson Pharmaceuticals and other top pharmaceutical and biopharmaceutical companies. Some of the topics that will be covered include technology transfer, process validation, data integrity, drug shortages, assessing blend and content uniformity, an industry-regulatory roundtable, and an encore of last year's popular Breakfast With the Inspectors session.

The 3rd Annual ISPE-FDA CGMP Conference is part of ISPE's Global Quality Week, along with the 2014 ISPE Facility of the Year Awards Banquet on 3 June and the CMO Executive Workshop on 4 – 5 June. Complete details of the event, including full speaker lists, 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. Visit www.ISPE.org for more information.

For more information contact:
Danielle Hould
Manager, Marketing Communications, ISPE
Tel: +1-813-960-2105, ext. 277
Email: dhould@ispe.org

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