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:12/1/2015)... Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage company developing novel ... the company will present at the LD Micro Main Event. ... Sunset Boulevard Hotel in Los Angeles, CA. ... present on Thursday, December 3, at 9:00 am Pacific time ... at least 10 minutes prior to the start of the ...
    (Date:12/1/2015)... Dec. 1, 2015   MabVax Therapeutics Holdings, Inc ... announces it has filed an Investigational New Drug Application ... for the Company,s lead fully human antibody product HuMab ... MabVax plans to initiate the Phase I clinical trial ... --> The planned Phase I trial will ...
    (Date:12/1/2015)... 2015   Craneware, Inc ., the healthcare ... announced the company will showcase a new version ... solution at the American Society for Health-System ... The new features are focused on simplifying and ... managing enterprise-wide pharmacy charges to ensure compliance and ...
    Breaking Medicine Technology:
    (Date:12/1/2015)... ... 2015 , ... Speech and physical therapies are traditionally conducted ... and under the right circumstances, these practices can be merged. This combination ... his or her therapeutic sessions, as well as gives the physical and speech ...
    (Date:12/1/2015)... Wayland, MA (PRWEB) , ... December 01, 2015 , ... ... adults has a tattoo — a number even greater among Millennials (a whopping one ... there are more and more people who are dissatisfied with their ink. In fact, ...
    (Date:12/1/2015)... Libertyville, IL (PRWEB) , ... December 01, 2015 ... ... catheters, keeping their independence is everything. That is why Hollister Incorporated has launched ... excited to offer this next product in the VaPro touch free catheter portfolio,” ...
    (Date:12/1/2015)... ... December 01, 2015 , ... Lutronic, a leading innovator of ... latest addition to the devices for sale in the United States. Clarity is ... long-pulsed 1064 nm Nd:YAG lasers, into a single platform that is easy to own ...
    (Date:12/1/2015)... , ... December 01, 2015 , ... With FCPX ... and with full control over customization, the possibilities are truly endless, all with a ... randomization, overlay depth position, vertical flip, horizontal flip, depth of field and more, all ...
    Breaking Medicine News(10 mins):