Search results Search for: Search Refine your results by duration: Any Under 5 mins Under 20 mins Over 20 mins Sort by: Relevance Views Date Mass Transport Modelling in support of leachable risk management. Thomas Egert at Boehringer Ingelheim Pharma and Jason Creasey at Maven E&L Ltd Leachable risk management continues to be of regulatory interest. However we continue to rely on experimental extractable studies as predictors of lea... 2 months ago | 103 mins Safety Evaluation on Extractables and Leachable Dr Clemens Günther, at Bayer AG, R&D Pharmaceuticals and Tino Otte at Intertek Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals 5 months ago | 159 mins The Importance of Accurate Chemical Characterization of Medical Devices... Ron Brown, Toxicologist at Risk Science Consortium and Dries Cardoen, PhD, Sr. E&L Expert – Team leader at Nelson Labs Full title: The Importance of Accurate Chemical Characterization of Medical Devices Extractables Chemical characterization of medical devices, involv... 4 months ago | 134 mins ICH Q3E Impurity Guidelines: Assessment and Control of Extractractables... Jason Creasey at Maven E&L Ltd, and Philippe Verlinde at Nelson Labs Full title: ICH Q3E Impurity Guidelines: Assessment and Control of Extractractables and Leachables for Pharmaceuticals and Biologics. 6 months ago | 116 mins Challenges In Therapeutic Biological Products Paolo Grisostomi at Biogen, Donald Young Thermo Fisher Scientific and Dr. Sona Kovackova at Nelson Labs Europe Presented by Paolo Grisostomi, Senior Engineer, Materials Science at Biogen and Donald Young, Sr. Product Manager at Thermo Fisher Scientific 7 months ago | 158 mins Handling mutagenic extractable and leachable compounds released from devices Ron Brown, Toxicologist at Risk Science Consortium and Piet Christieans, PhD, Scientific Director at Nelson Labs Genotoxic compounds can be released from some medical devices during their clinical use. The ISO 10993-17:2002 standard outlines steps to assess the ... 1 year ago | 115 mins An impurity detected in a stability study... Petra Booij, Investigator bij GlaxoSmithKline and Ward D’Autry, PhD Study Director at Nelson Labs Europe Full Title: An impurity detected in a stability study: Did we miss anything in our E&L risk assessment? Extractable and leachable (E&L) testing are r... 1 year ago | 90 mins Case Study and Experience on Sanofi's and SGS's Implementation of BPOG's Leachab Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of Extractables & Leachables at SGS Case Study and Experience on Sanofi's and SGS's Implementation of BPOG's Leachable Risk Assessment Model and Extractable Testing Protocol Presented b... 3 years ago | 88 mins Future Trends To Control Risks From Extractables and Leachables Presented by Jason Creasey, Managing Director at Maven E&L Ltd and Kathleen Lava PhD – E&L Expert Nelson Labs Europe Presented by Jason Creasey, Managing Director at Maven E&L Ltd Jason Creasey is a graduate Analytical Chemist. He has recently setup as an independen... 2 years ago | 105 mins Identification of unknown extractables and leachables using mass spectrometry... Petra Booij, Investigator at GlaxoSmithKline & Dr Kyle D’Silva, Pharma & BioPharma Marketing Leader, Thermo Fisher Scientific Full Title: Identification of unknown extractables and leachables using mass spectrometry: Identification with confidence? Extractable and Leachable ... 3 years ago | 57 mins Load more
