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
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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.
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.
In this course, you will receive a thorough overview of the clinical supply chain from beginning to end, including: designing appropriate packaging....
One of the major changes introduced by the European Union (EU) regulation 536/2014 is an application procedure that will require sponsors to apply for authorization to conduct an interventional/low-intervention clinical trial (CT) via a new EU portal.3
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In an effort to harmonize the clinical study drug supply labeling requirements, Chapter X of the Regulation provides rules for clinical labeling. Further, to fill perceived gaps in individual member state requirements, annex VI was added to the...
One of the major changes the EU Clinical Trial Regulation2
will introduce is a new clinical trial (CT) application procedure. Under the Regulation, Sponsors will be required to apply, via a new EU portal for authorisation to conduct an interventional...
