spacer
home > pmps > summer 2019 > staying ahead of the curve
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Staying Ahead of the Curve

In the grand scheme of clinical trial planning, labelling processes may seem insignificant in comparison to obvious fundamentals such as drug manufacturing, securing funding, or patient recruitment. As clinical packaging is typically approached sequentially (manufacture, package, label, ship), it is unsurprising that labelling is usually only properly considered and defined during the latter stages of the process. It is just a label after all, right?

Wrong. A label is the first thing a patient – and a regulator – will see when they receive a kit. A label is also vital in the bid to obtain approval in countries where a trial is operating. With the American Journal of Health citing that incorrect labelling is one of the top five reasons for drug recall in the US, it is time we acknowledge the real role labelling plays in the bigger picture of a clinical trial’s success.

Clinical trials are changing rapidly, and this is having a big impact on labelling processes, which need to evolve to meet increasingly complex criteria. Labels are no longer used as a basic table of contents, but they need to be multifunctional and used to deliver variable information in different formats and languages. The core drivers for change can be grouped into four categories: the emergence of biologics products, growth in global trials, increased regulation, and adaptive trials − each bringing its own set of labelling challenges.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
James McAleavey graduated from Queen’s University Belfast, UK, with a BSc honours degree in Mathematics and Computer Science. James joined Almac Clinical Services in 2002, having previously worked within the labelling industry for almost 10 years. As part of Almac’s global label services team, he is a subject matter expert on the challenges of the regulatory and design aspects of labels within a clinical trial and the key role they play in ensuring successful study and patient compliance. He has extensive experience in the auditing of label manufacturing and packaging sites throughout the world, imparting knowledge on the regulatory requirements and industry expectations.
spacer
James McAleavey
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

SEKISUI XenoTech Receives New US Patent for a Method to Evaluate Xenobiotics as Immune-Modulators of Drug Transport and Metabolism in Hepatocytes

Kansas City, KS- SEKISUI XenoTech has been awarded US patent # 10,648,968 “In vitro test system to evaluate xenobiotics as immune-modulators of drug transport and metabolism in human hepatocytes.”
More info >>

White Papers

Maximize the ROI of Your Post-Approval Research

Bioclinica

Expenditures in post-approval (Phase IV) research are going up across the pharmaceutical, biotech and medical device industries. Given the resources you’ve committed to post-approval research, you may be wondering if you’re getting the greatest possible return on your investment. Discover how to harness the power of post-approval research to increase data collection, reduce resource burn, save money, and maximize your ROI!
More info >>

 
Industry Events

World Vaccine Congress Washington

27-29 September 2020, Walter E Washington Convention Center, Washington, US

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement