We are happy to announce Nelson Labs will be exhibiting in booth L56 with our sister company Sterigenics at the 2020 Pharmapack tradeshow, in Paris, France February 5-6, 2020.
Nelson Labs will have consultants available to Pharmapack participants to answer even the most difficult testing and compliance questions. Stop by booth L56 for a complimentary personalized 30 minute consultation, and mark your calendar for Nelson Labs’ educational lectures, and roundtable debate (additional details provided below).
Nelson Laboratories’ Pharmapack Events:
Topic: Changing Regulatory Requirements for Extractables & Leachables Testing on Pharmaceutical Packaging Systems
Date: 5 February
Time: 10:00 – 10:40
Presenter: Anja Cerstiaens, PhD
In the past decades, scrutiny has changed in the way EMEA or FDA regulators look at Extractables & Leachables data. Requirements gradually increased, not backed up with any official documentation (Guidance, guideline…) which left the Pharmaceutical Industry in the dark. Second guessing of what the current position and requirements of regulators are to support a submission became the normal.
In this presentation, the key factors of success of any given E&L project will be highlighted. Crucial is to understand what regulators really want and to align the design space of an E&L study to their expectations.
Facing the reality of the ever-evolving regulatory landscape, analytical testing labs need to be on the forefront with expertise in the field of Extractables and Leachables testing and state-of –the art technology. Meeting the development needs and requirements, of the pharmaceutical and biopharmaceutical industries, also raises the bar for material suppliers.
Only through successful partnering between drug product vendors, material suppliers and the CRO performing the test, a true mitigation of the risk related to packing can be established.