Navigation Links
ISPE Announces Plans for Its Drug Shortages Initiative through 2014
Date:11/2/2013

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: http://photos.prnewswire.com/prnh/20120912/DC73253LOGO )

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:
Pending

 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 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 


    '/>"/>
    SOURCE ISPE
    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:
    *Name:
    *Comment:
    *Email:
    (Date:10/11/2017)... FRISCO, Texas , Oct. 11, 2017 /PRNewswire/ ... healthcare services, has amplified its effort during National ... patients about hereditary cancer risks. ... Journal of Clinical Oncology calculated that more than ... to have inherited mutations in BRCA1 or BRCA2 and ...
    (Date:10/10/2017)... Oct. 10, 2017   West Pharmaceutical Services, Inc. ... for injectable drug administration, today shared the results of ... for improving the intradermal administration of polio vaccines. The ... Summit in May 2017 by Dr. Ondrej Mach ... World Health Organization (WHO), and recently published in the ...
    (Date:10/4/2017)... South Korea , Oct. 4, 2017  South ... its next-generation CPR training aide "cprCUBE" on Kickstarter. The ... chest compression during cardiac arrests with better efficiency compared ... It also offers real-time feedback on efficacy of the ... The crowdfunding campaign has a goal to raise $5,000. ...
    Breaking Medicine Technology:
    (Date:10/12/2017)... ... October 12, 2017 , ... ... treating sleep apnea using cutting-edge Oventus O2Vent technology. As many as ... disorder characterized by frequent cessation in breathing. Oral appliances can offer significant relief ...
    (Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( ... today the introduction of an innovative new design of the shoulder pad. The ... get maximum comfort while controlling your pain while using cold therapy. By utilizing ice ...
    (Date:10/12/2017)... ... October 12, 2017 , ... Information about the technology: ... develop to enable prevention of a major side effect of chemotherapy in children. ... pediatric patients. For cisplatin, hearing loss is FDA listed on-label as a dose ...
    (Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at ... D.C., for the 49th Congress of the International Society of Paediatric Oncology ... the Center for Cancer and Blood Disorders at Children’s National, and Stephen ...
    (Date:10/12/2017)... ... 12, 2017 , ... Health Literacy Innovations (HLI), creator of ... and the Cancer Patient Education Network (CPEN), an independent professional organization that shares ... strategic alliance. , As CPEN’s strategic partner, HLI will help support CPEN ...
    Breaking Medicine News(10 mins):