Header Artwork
Header Artwork


Addressing Common Observations in Regulatory Submissions of Chemical Characterization Results

May 27, 2020

Presenter: Dr. Piet Christiaens (Scientific Director at Nelson Labs Europe)

The observations of health authorities on the analytical approaches used in chemical characterization of medical devices are mainly given in order to guarantee that no errors will be made in the Chemical Assessment that could impact the outcome of a subsequent Toxicological Risk Assessment. The recently published series of articles “Errors in Chromatographic Screening” (PDA Journal) address the errors that can be made in chromatographic screening in Extractable Studies and also make the evaluation on how a supporting database could assist in avoiding the occurrence of such errors. The presentation will take a deeper dive in how the information that is gathered in a database can assist these regulatory observations.