The impact on current mutual commerce and regulatory recognition between the UK and other EU countries was and is still unclear. Pharma cannot afford to wait and see what the impact is on the release and distribution of Clinical Trial Material from the...
This article presents an adaptation of clinical trial management to ICH E6 (R2). A case study assesses quality risks in a clinical data management system.
Enhanced and accelerated regulatory pathways for “Breakthrough Therapies (United States) and “PRIME” medicines (European Union) have been introduced to provide faster access to exciting new therapies developed to treat unmet medical needs.1,2 Jokura et...
The digital revolution is driving change across all industries. With its ability to increase transparency and trust between parties, the recent innovation called blockchain has the potential to significantly disrupt the clinical trials industry.
This online training session will cover a case study of the selection, installation and operation of a flexible design and production platform that allows for clinical vaccine production. This unique cGMP mobile adaptive...
Published: March 2013 Pages: 42 Table of Contents Special Pricing for Emerging Economies This Guide was written to create methods for standardizing the format, design, and content of clinical trial booklet labels. Because booklet labels contain vital
The Introductory US Clinical Trial Materials Training Guide has been created to familiarize new investigational trial materials professionals by pulling together the terms and related information they need to be successful in their field.
Gain insight on functions and pathways involved in product development, including the purpose and conduct of clinical trials in Phases I, II, and III. Better understand how decisions during drug development (i.e., dosage...
In this online course, you will receive a thorough overview of the clinical supply chain from beginning to end, including designing appropriate packaging and labeling to match the study design, creating a plan of action...
