Virtual European Workshop on Extractables & Leachables for Medical Devices

The identification of extractables, leachables and chemical migration is a challenge for manufacturers and suppliers of packaging materials, medical devices and food contact materials. E&L analytics is already complex, but it is compounded by legislative and regulatory efforts to recycle plastics. Analytical methods need to screen for not only the known components but also identify degradants and other unexpected compounds. Manufacturers, producers and retailers face the challenge of keeping up with evolving requirements and developing and adapting strategies to reduce plastic waste.

Thus, ways are being explored to incorporate more recycled plastics into products and packaging while maintaining excellent safety, quality and performance characteristics. As they innovate and combine new materials, companies must demonstrate safety and confirm compliance before bringing their products to market. This again increases the demand and importance of highly effective analytics.

Register now for this virtual event and share knowledge and challenges with peers and E&L experts.

Who Should Attend?

The webinars are focused on the needs of scientists working in the area of Extractables & Leachables and Food Contact Materials. During these webinars, attendees will learn:

• Upcoming and new regulations in the field of food, pharma, biopharma and medical devices

• Targeted and non-targeted screening workflows by using Waters_Connect

• Characterization and structural elucidation of unknowns

• Choice of chromatographic techniques, extraction methods and analytical standards & reagents

EPISODE 3 - Virtual European Workshop on Extractables & Leachables for Medical Devices

Agenda:

The role of chemical characterization in the evaluation of the biological safety of medical devices

• Dr. Séverine Colas, Chief Scientific Officer, TentaConsult Pharma & Med GmbH, Germany

Chemical Characterisation of Dressings: Extraction and Analytical Challenges

• Pauline Kisseleff, Analytical Expert, URGO Recherche Innovation et Développement, France

Leachables from Pharma and Medical device materials, a non-target challenging analysis

• Prof. Cristina Nerin, University of Zaragossa, Spain

Presenter: Dr. Séverine Colas (Chief Scientific Officer, TentaConsult Pharma & Med GmbH)

Séverine Colas is a PhD and a toxicologist (ERT) with more than fifteen years of experience in regulatory toxicology. She has always worked in services for the safety and regulatory compliance of products, initially with pharmaceuticals, then with chemicals and for more than 10 years now with medical devices. She has joined the TentaConsult team to provide to the client her strong expertise on biological evaluation of medical devices (MDR, ISO 10993-1 and related guidelines) and support them to establish the best strategy for the compliance of their medical device throughout their life cycle. If testing is needed to complete the evaluation, she also provides the client with her experience in conducting biocompatibility studies to find the suitable laboratory and to establish the more pertinent study design. As Chief Scientific Officer and Sales Director in TentaConsult, she is the preferred contact of the client to provide the best offer for the need.

Presenter: Pauline Kisseleff (Analytical Expert, URGO Recherche Innovation et Développement)

Pauline Kisseleff has a Master degree in analytical chemistry and received her PhD on container-content interactions applied to cosmetic products in 2020. She is currently in charge of extractables and leachables studies at URGO Research, Innovation and Development, where she works on several medical devices such as technological dressings

Presenter: Cristina Nerin (Professor, Department of Analytical Chemistry, University of Zaragoza)

Full Professor at the University of Zaragoza (Spain), PhD in Analytical Chemistry, Master in Science (Analytical Chemistry) and Degree in Chemistry at the University of Zaragoza (Spain). Director of the Research Group GUIA at the University of Zaragoza and Director of the Master in Environmental Engineering at the University of Zaragoza from 1990 to 2012. Author of more than 395 Scientific Publications included in the Citation Index, Director of 38 PhD Thesis (5 more are in process). Principal Investigator of more than 240 Research Projects in both Competitive calls and also R&D&I with Industry Inventor in six International Patents dealing with active packaging and in one International Patent on Intelligent Packaging. All of them are in exploitation (market). Six Research Awards received. Participant in more than 140 International Conferences and Professor of several International Courses n Europe, Asia and South-America.