Navigation Links
ISPE Announces Plans for Its Drug Shortages Initiative through 2014

TAMPA, Fla., Nov. 2, 2013 /PRNewswire/ -- 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.

(Logo: )

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

 ISPE Aseptic Annual Conference Date: 24-25 February 2014

 Location: Washington, D.C., USAAprilIndustry-Regulatory Roundtable: The Roles of Quality Culture and Regulatory Relationships in Preventing Shortages

 ISPE Europe Annual Conference - Driving Effectiveness in Pharmaceutical Operations within the new Quality Culture Date: 28-30 April

 Location: Frankfurt, GermanyJune(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

 Pharmaceutical Quality Week Date: 2-5 June

 Location: Washington, DC, USA

 SeptemberIndustry Roundtable: IMPs and Drug Shortages

  ISPE Investigational Products Conference - Investigational Products in a Global Environment Date:

 Location: Europe pendingOctoberExecutive Session: Second Annual Report on ISPE Research Related to Preventing and Mitigating Drug Shortages

 ISPE Annual Meeting Date: 12-15 October

 Location: Las Vegas, NV, USANovemberIndustry Roundtable: Facilities and Equipment Issues, the CMC Process, and Drug Shortages

 The Conference at Pharma EXPO Date: 2-4 November

 Location: Chicago, IL, USAPublished in June 2013, ISPE's Drug Shortages Survey report is available at 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 for more information. To learn more about ISPE's Annual Meeting visit

    For more information contact:
    Danielle Hould
    ISPE Membership Marketing Communications Manager
    Tel: +1-813-960-2105, ext. 277

    Copyright©2012 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. Pharmacyclics Announces Date of Conference call to discuss Financial Results for Third Quarter Ended September 30, 2013
    2. IGI Laboratories, Inc. Announces Thirteenth ANDA Submission
    3. Pharmagen Announces Shift In Growth Strategy
    4. Array BioPharma Reports Financial Results For The First Quarter Of Fiscal 2014 And Announces ARRY-520 Development Strategy
    5. MSA Announces Fourth Quarter Dividend
    6. Sorrento Therapeutics Announces Closing of Public Offering of Common Stock
    7. Veracyte, Inc. Announces Pricing of Initial Public Offering
    8. iHealth Announces Availability of Wireless Smart-Gluco Monitoring System
    9. Merrimack Pharmaceuticals Announces Results From A Phase 2 Study Of MM-121 (SAR256212) In Combination With Paclitaxel In Patients With Platinum-Resistant Or Refractory Advanced Ovarian Cancers
    10. IGI Laboratories Announces Third Quarter 2013 Results
    11. UBM Announces Free Educational Content at MD&M Minneapolis and MinnPack
    Post Your Comments:
    (Date:11/26/2015)... 2015 3D bioprinting market is ... a new report by Grand View Research Inc. Rising prevalence ... demands kidney transplantation is expected to boost the market growth, ... organ transplantation. --> 3D bioprinting market is ... a new report by Grand View Research Inc. Rising prevalence ...
    (Date:11/26/2015)... Research and Markets ( ) ... Future Horizons and Growth Strategies in the Japanese ... Segment Forecasts, Competitive Intelligence, Emerging Opportunities" report ... --> This new 247-page report ... drug monitoring market, including emerging tests, technologies, instrumentation, ...
    (Date:11/26/2015)... 2015 ) ... "2016 Future Horizons and Growth Strategies in ... Supplier Shares, Country Segment Forecasts, Competitive Intelligence, ... --> ) has announced ... Horizons and Growth Strategies in the French ...
    Breaking Medicine Technology:
    (Date:11/26/2015)... ... November 26, 2015 , ... Inevitably when people think Thanksgiving, they ... to buy during the Black Friday and Cyber Monday massage chair sales ... the Internet high and low to find the best massage chair deals, they can ...
    (Date:11/26/2015)... , ... November 26, 2015 , ... ... real-time eReferral system for diagnostic imaging in the Waterloo region. Using the Ocean ... Nuclear Medicine tests directly from their electronic medical record (EMR) without the need ...
    (Date:11/26/2015)... ... November 26, 2015 , ... Somu ... As a franchise owner, Somu now offers travelers, value and care based Travel ... private cruise sales, as well as, cabin upgrades and special amenities such as, ...
    (Date:11/26/2015)... ... November 26, 2015 , ... The Catalent Applied Drug Delivery ... to integrate dose form selection in early phase drug development. The first of ... and bringing together the UK’s emerging life sciences companies, corporate partners, and investors, ...
    (Date:11/26/2015)... ... November 26, 2015 , ... Jobs in hospital medical ... professionals and offered by healthcare staffing agency Aureus Medical Group . ... of October 2015 among those searching for healthcare jobs through the company’s website, ...
    Breaking Medicine News(10 mins):