Navigation Links
ISPE Releases New Guidance for Standardizing Use of Booklet Labels in Global Clinical Trials
Date:4/3/2013

Tampa, Fla. USA (PRWEB) April 03, 2013

ISPE, a leading authority on best practices for the pharmaceutical industry, announced today that it has issued the industry’s first-ever guidance to help companies conducting clinical trials in multiple countries standardize their use of booklet labels. The Guide provides templates, guidelines and tools to make it easier for companies to use booklet labels consistently and effectively and justify their booklet label methods to international regulatory authorities.

“ISPE is pleased to introduce its first Guide to support harmonization of labeling requirements globally,” said ISPE President and CEO Nancy S. Berg. “Companies involved in clinical trials now have a resource that provides guidance on how to design and structure a booklet label and how to standardize the use and application of booklet labels for global clinical trials. By following the recommendations presented in the Guide, companies can feel confident that their booklet label strategy is supported by a scientific, risk-based methodology and patients are receiving accurate, complete instructions in their local language.”

The ISPE Good Practice Guide: Booklet Labels has been reviewed by MHRA officials, and their feedback has been incorporated into the Guide’s content. The Guide’s recommendations will help companies determine the gaps between their current booklet label procedures and best practices. It contains resources for training clinical trial personnel on proper booklet label use and templates that companies can put into practice immediately to help improve compliance and cost-effectiveness of their clinical trials.

The ISPE Good Practice Guide: Booklet Labels is available for purchase on the ISPE website.

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 entire 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 and offices in Brussels, Belgium, Singapore and Shanghai, China. Visit http://www.ISPE.org for more information.

Read the full story at http://www.prweb.com/releases/ispe/bookletlabels/prweb10598139.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. GLM Displays Releases New & Improved Hop-Up Displays
2. eScience Labs Releases 2nd Edition Anatomy and Physiology Lab Kit
3. Manipulating the Brain to Eliminate Fear or Restore Memories – Rudy Mazzocchi Releases the 2nd Novel in The EQUITY Series entitled "EQUITY of FEAR"
4. Boca Bearings Releases Packaging Industry Bearings
5. Why Plastic Water Baths Prevent the Contamination of Samples - Revolutionary Science Releases a Brand New Poly ProBath Video
6. BioPharm Insight Releases its Catalyst Monitor for April 2013
7. SoundMindz TM Releases ‘Anti-Anxiety TM’ Mobile App - A Complete Stress Therapy Program
8. HCCS Releases New Social Media Online Training Course
9. Smith & Nephew releases new Modular Rail System in collaboration with Dr. Dror Paley
10. Organic-Based Bed Bug Spray Kills Bed Bugs in Seconds, My Cleaning Products Releases Samples of the Product
11. Infinata’s BioPharm Insight Releases Licensing League Tables Report for 4Q12 and YE12
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2016)... OXFORD, England , May 23, 2016 ... Wednesday, May 25 th at 10:15 a.m. ET before ... about the role genetically engineered mosquitos can play in controlling ... known carrier of the Zika virus.      (Logo: ... genetically engineered male mosquito with a self-limiting gene. Trials in ...
(Date:5/20/2016)... ... 20, 2016 , ... The leading Regenerative Veterinary Medicine Company, VetStem Biopharma ... treated over 100 of their own patients with the VetStem Cell Therapy. Each of ... care for their patients. , The veterinarians are Dr Ross Rich former owner ...
(Date:5/19/2016)... , May 19, 2016  AdvancedFlow Systems Inc. ... (AGI), based out of Maple Ridge, ... Ltd. to its existing portfolio of contract manufacturing ... AFS along with its sister companies Surround Technologies ... vertically integrated industrial group that specializes in providing ...
(Date:5/18/2016)... Calif. (PRWEB) , ... May 18, 2016 , ... ... awarded the Luis Villalobos Award to Cognition Therapeutics at the annual ACA Summit last ... company that is financed by one of ACA’s member angel groups. It is the ...
Breaking Biology Technology:
(Date:3/31/2016)... , March 31, 2016  Genomics firm Nabsys has ... CEO, Barrett Bready , M.D., who returned to ... the original technical leadership team, including Chief Technology Officer, ... Product Development, Steve Nurnberg and Vice President of Software ... the company. Dr. Bready served as CEO ...
(Date:3/23/2016)... 23, 2016 ... Gesichts- und Stimmerkennung mit Passwörtern     ... MESG ), ein führender Anbieter digitaler ... mit SpeechPro zusammenarbeitet, um erstmals dessen Biometrietechnologie ... die Möglichkeit angeboten, im Rahmen mobiler Apps ...
(Date:3/22/2016)... OTTAWA, Ontario , PROVO ... 2016 Newborn Screening Ontario (NSO), which operates ... for molecular testing, and Tute Genomics and ... process management technology respectively, today announced the launch of ... new next-generation sequencing (NGS) testing panel. ...
Breaking Biology News(10 mins):