April 2008

Feature Article:

The Effect of Quality Management on Compliance with European Union GMP Standards

For Pharmaceuticals:

Investigating the Investigators: Another Headache for Drug Sponsors

For Medical Device:

The Medical Device Market in Japan: Worth its Weight in Gold?

For Blood & Biologics:

San Antonio Hospital Aims to Perform "Bloodless" Surgeries

GLP Management:

Top Benefits of Electronic GLP Management: What Non-Clinical Research Laboratories Should be the First to Know

Did You Know?

Do you know what happens to your eCTD submission once you have sent it to the FDA?



Upcoming Events

Glossary

Submissions

Editorial Staff

Feature Article: The Effect of Quality Management on Compliance with European Union GMP Standards

How crucial is Europe to the global pharmaceutical market? First consider that Europe, North America, and Japan comprise 80 percent of the world's pharmaceutical market. Take that statistic in conjunction with the estimation from Report Buyer, a renowned market research firm, that the Western European market alone is expected to grow to $245.3 billion by 2012.

The engine that drives the European pharmaceutical market machine is, without question, the European Union (EU). With 27 member states, the EU represents the bulk of the European market. The 10 individual European markets that joined the EU in 2004 continue to show strong growth and contribute to the EU pharmaceutical market's overall strength. Pharmaceutical companies searching for further success in Europe or those wanting to capitalize on these strong growth trends by entering the European market for the first time must efficiently and cost-effectively obtain and maintain marketing authorization (MA).
Read more.    Additional Feature Articles.


For Pharmaceuticals: Investigating the Investigators: Another Headache for Drug Sponsors

One leading indicator of a more enforcement-minded approach at the food & drug administration may be a crackdown on clinical trial investigators suspected of fraud. One thing is already clear: sponsors who rely on investigators who trigger suspicions will pay a price in the form of an even tougher time getting the drug through FDA.

This would be a good time for biopharma companies to review their ongoing clinical trials to determine whether any investigators involved in the study are vulnerable to potential disqualification proceedings by the Food & Drug Administration.
Read more.    Additional Pharmaceutical Articles.


For Medical Device: The Medical Device Market in Japan: Worth its Weight in Gold?

For medical device makers the device market in Japan is a literal gold mine.

It isn't only the need for devices and the ready funding that attracts U.S. device makers to Japan. Japan's medical device expertise also acts as an added enticement. Device makers in Japan have a specialized knowledge that U.S. device makers could learn from and vice versa.
Read more.    Additional Medical Device Articles.


For Blood & Biologics: San Antonio Hospital Aims to Perform "Bloodless" Surgeries

Northeast Baptist Hospital in San Antonio, Texas has adopted a perioperative blood management program, aiming to perform 90% of surgeries without blood transfusions. The hospital has received support from the South Texas Blood & Tissue Center, which says bloodless facilities help ease the demand for blood and tissue donations.

Blood transfusions are standard practice during many surgeries, but now a local hospital says it can do even complicated, open-heart procedures without transfusing blood. It says the surgeries are safe, less expensive and the patients recover faster.
Read more.    Additional Blood & Biologics Articles.


GLP Management: Top Benefits of Electronic GLP Management: What Non-Clinical Research Laboratories Should be the First to Know

Industrialized nations, such as the United States, the European Union and Japan, have increasingly aging populations and are experiencing unprecedented growth in demands for healthcare and related technologies.

Life science companies, as active players in the quest to meet public healthcare demands, are striving to produce more products while maintaining and improving product quality.
Read more.


Did You Know?

Do you know what happens to your eCTD submission once you have sent it to the FDA? In March of this year, the FDA issued the validation criteria to be used for their validation processes. Specifications for eCTD Validation Criteria version 1.0 outlines the items that will be checked in the eCTD and grades errors found by severity.
Read more.


If you would like to subscribe to GxP Lifeline, forward it to a colleague or unsubscribe, please click here.

Return to Top