2014 Drug Shortages Plan Press Release

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FOR IMMEDIATE RELEASE

ISPE Announces Plans for Its Drug Shortages Initiative through 2014

Monday FDA’s Captain Valerie Jensen on Dais
to Discuss Agency Direction in Confronting the Challenge of Drug Shortages

(TAMPA, FLORIDA, USA, 2 November 2013) – ISPE today announced a lineup of activities that will bring pharmaceutical industry stakeholders together several times in the coming year to address the issues leading to shortages in the global drug supply. Beginning Monday 4 November 2013 the Society will offer a series of education sessions, training and roundtable events for industry leaders and regulators. These meetings will focus on addressing the results of ISPE’s 2013 Drug Shortages Survey, the findings of follow up research, and pathways to improving processes that could mitigate or avoid shortages.

The series of events will begin with the ISPE Drug Shortages Task Force progress report Monday at ISPE’s Annual Meeting in Washington, DC. The didactic portion of the session will focus on the possible connection between drug shortages and the lengthy chemistry, manufacturing, and control (CMC) process; a description of key operational elements in manufacturing that appear critical to avoiding shortages will also be provided. During the interactive portion of the session, Captain Valerie Jensen, R.Ph., Associate Director for FDA’s Center for Drug Evaluation and Research’s (CDER’s) Drug Shortage Program, will join a panel hosted by ISPE for a question and answer session with the audience. Captain Jensen’s participation on the panel comes just four days after the release FDA’s Strategic Plan for Preventing and Mitigating Drug Shortages.

The full ISPE Drug Shortages event schedule for 2014 includes:
February Industry Roundtable: Keys to Addressing Quality System Issues in Aseptic Manufacturing which May Lead to Shortages

February

Industry Roundtable: Keys to Addressing Quality System Issues in Aseptic Manufacturing which May Lead to Shortages

April

Industry-Regulatory Roundtable: The Roles of Quality Culture and Regulatory Relationships in Preventing Shortages

June

(1) Plenary Session: Report of the ISPE Drug Shortages Task Force on Emerging Strategies for Preventing and Mitigating Shortages

(2) Industry-Regulatory Roundtable: Implications of the Findings of the Drug Shortages Task Force

September

Industry Roundtable: IMPs and Drug Shortages

  • ISPE Investigational Products Conference:
    Investigational Products in a Global Environment
    Date: Pending
    Location: Europe; city pending

October

Executive Session: Second Annual Report on ISPE Research Related to Preventing and Mitigating Drug Shortages

November

Industry Roundtable: Facilities and Equipment Issues, the CMC Process, and Drug Shortages

Published in June 2013, ISPE’s Drug Shortages Survey report is available at www.ISPE.org/Drug-Shortages/2013JuneReport. The comprehensive global survey revealed no single technical or manufacturing cause for drug shortages. Instead, initial data analysis showed:

  • Issues within the quality systems of manufacturing can lead to drug shortages.
  • Companies that have successfully avoided drug shortages focus on strong quality systems, and the involvement of company leadership is notable in those companies that avoid shortages.
  • Improved regulatory interaction can mitigate the likelihood of a shortage.

The report was cited in the FDA’s Strategic Plan for Preventing and Mitigating Drug Shortages published in October, and the survey data will provide the necessary context for the 2014 events.

“As a neutral organization focused on product quality and patient safety, ISPE is uniquely positioned to take a leadership role in bringing the pharmaceutical industry’s stakeholders together around the challenge of drug shortages,” says Nancy S. Berg, President and CEO of ISPE. “The survey revealed many new opportunities for ISPE to facilitate dialogue and work together with key influencers on solutions to mitigate or reduce shortages. We are committed to fulfilling that role.”

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. To learn more about ISPE’s Annual Meeting visit www.ISPE.org/2013AnnualMeeting.

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

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