Clinical Trials Labeling
We have spoken with our customers and many consider Annex VI of the forthcoming EU Clinical Trial Regulations introduces new labeling challenges.
In particular, the Annex VI D (replacing of information) indicates any changes to period of use (expiry/retest) requires a change on the immediate (primary) pack label as well as outer (secondary) pack, performed within a GMP environment.
As a result, it may be no longer acceptable to perform expiry date extensions on labels on the outer packaging only and rely on an IRT/RTSM system being the source of the latest date for inner, primary packs.
This new regulation therefore requires changes to process for many in the industry; following our research, we found several different approaches being taken by US and European Clinical Trial companies to comply.
Join us for this information-packed webinar to hear more.
Gordon Alexander ,
Enterprise Pre-sales Engineering, PRISYM ID
Gordon is involved in understanding customer needs and industry challenges to drive solutions to improve efficiency, minimize risk, address regulatory requirements and provide new approaches to business systems and processes. Gordon has 20 years of technical software experience with roles as industry consultant, business analyst, and pre-sales engineering.
VP Global Products, PRISYM ID
Simon has 20 years of experience in delivering product strategies and product positioning which address market opportunities effectively. He is a subject expert in clinical trials labeling, researching this market, discussing the industry challenges with the PRISYM ID customers and remaining up to date on market trends, regulatory changes and technology alternatives.