The Falsified Medicines Directive – What Does It Really Mean?
The trade in falsified medicines — medicines that look real but really aren’t what they seem — is a huge and growing one, and it is putting patients’ health and even their lives at risk. Along with regulatory authorities around the world, the European Union is putting directives into place that could begin to slow this deadly trade.
WHITE PAPERS & CASE STUDIES
Serialization And The Drug Quality & Security Act: A Top-Down Synergistic Approach
Hang around pharmaceutical drug manufacturers long enough and the conversation will undoubtedly turn to the global dilemma of safeguarding the public from the proliferation of counterfeit drugs, and the Drug Quality and Security Act (DQSA).
Don’t Get Blindsided By New USP Quality Standards
The U.S. Pharmacopeial Convention’s (USP’s) Chapter 41 minimum quality standards for weights and balances have been updated after twenty years – and every pharmaceutical manufacturer has been waiting to see what that means in practice when the standards go into effect in December 2013. By Dirk Ahlbrecht, Sartorius Group
Points To Consider When Developing A TMF (Trial Master File) Strategy
Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). By Karen Redding, Global Business Development Director, Phlexglobal Ltd.
Improve Accuracy And Efficiency In Data Collection For Mental-Health Evaluations And Assessments
MedAvante is a global provider of centralized, expert psychological rating services to the pharmaceutical, biotechnology, and medical device industries.
Selecting, Implementing, And Using FDA Compliance Software Solutions
We begin by asking the question, “Is the Quality Management Software market evolving to be easier, or more complex?”
Sustainable New Product Innovation With PLM Software
Siemens PLM Software’s product lifecycle management (PLM) platform helps transform the process of innovation that enables you to turn more ideas into successful and sustainable products. By Siemens Industry, Inc.