Workshop

About the Workshop- Central Theme and Key Areas

The overall assessment of Extractable and Leachable substances for both the primary pharmaceutical packaging as well as for pharmaceutical production equipment is extremely important in other to guarantee the safety and quality of drug products and to support regulatory filings. The workshop will give a comprehensive overview of the different aspects that need to be considered when putting together a testing program which will allow an in-depth E/L assessment of the pharmaceutical packaging and production equipment.

Topics that will be covered are:

Introduction to the Universe of Extractables
How to set-up Extractable & Leachable Studies for Pharmaceutical applications
Analytical approaches in E/L-testing
Extractable & Leachable Approaches for Small Volume Parenteral applications, Production Equipment, and Large Volume Parenteral applications
Toxicological Assessments of E/L-results.

About the Workshop Trainer

Dr. Piet Christiaens holds the position of Scientific Director at Nelson Labs where he developed analytical methods and protocols for both Extractables and Leachables studies for the Pharmaceutical Industry. In addition, he is also leading the R&D department at Nelson Labs, with a focus on understanding the interactions and chemistry of Extractable and Leachables and developing state-of-the-art analytical methodologies. In the two decades, Dr. Piet Christiaens has been invited as Subject Matter Expert as a speaker on over 150 conferences on the subject of “Extractables and Leachables”. He also wrote a series of peer-reviewed articles, e-books, and white papers and is involved in standard-setting organizations to develop future E/L guidances and standards.

About Nelson Labs

Nelson Labs Europe is a Contract Research Organisation specializing in providing premium Extractable & Leachable Services to the Pharmaceutical and Medical Device Industry. Based in Belgium, Nelson Labs Europe supports Pharma Companies - across the Globe - in developing worldwide compliant (FDA, EMA) Testing Strategies to qualify Container/Closure Applications and Pharmaceutical Production Equipment from an Extractable & Leachable Perspective. In addition, Nelson Labs also provides Sterility and Biocompatibility Testing Services to both the Medical Device and Pharmaceutical Industries.