Dr. Christian Pellevoisin, Scientific Director at Episkin Academy, will present 'Assessing Alternatives to In-Vivo testing: Changing the Paradigm from In-Vivo to In-Vitro Toxicology' during the Nelson Labs seminar in Brabanthal, Leuven, Belgium, March 4 & 5, 2020.
Scientific program:
Leuven Open House 2020: The Year Of Change for the Medical Device Industry
Wednesday, March 04, 2020
12:00 Registration & welcome
13:10 Introduction – Eric Meyers (Senior VP EMEAA Nelson Labs) & Jos Bollen (Managing Director Nelson Labs Europe)
13:30 The EU Medical Device Regulation (MDR): 2020: The Year of Change – Henry Sibun (Henry Sibun Associates Ltd)
14:00 The new ISO 10993-18 Standard and its Impact on Chemical Characterization of Medical Devices – Dr Ted Heise (Vice President Regulatory and Clinical Services at MED Institute)
14:30 Linking ISO 10993-18 to ISO 10993-17 – Dr. Carsten Baun Senholt (ERT Chief Technical Officer at Saxocon)
15:00 Coffee break
15:15 MDR – View of a Raw Materials Supplier - Steve Duckworth (Global Head Marketing and Business Development at Clariant)
15:45 ISO 10993-18 in the MDR: understanding the restrictions and risk assessmentfor compounds which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties (section 10.4) – Dr. Annelies Vertommen (Senior E&L Expert Nelson Labs Europe)
16:15 Tour of the Laboratory Facility
17:00 Networking event
19:00 End of Seminar Day 1
Thursday, March 05, 2020
08:30 Registration
09:00 Introduction (Nelson Labs Europe)
09:05 MDR – Biocompatibility & reprocessing - Dr Gert Bos (Executive Director & Partner at Qserve)
09:45 The Biological Evaluation Plan (BEP): A crucial first step in the Biocompatibility evaluation of a Medical Device – Dr Sophie Michel (Associate Biocompatibility Expert)
10:15 Competent Authority perspectives on biocompatibility – Dr Pieter Van De Vijver (Non-Clinical Assessor, Medical Devices at FAMHPS)
10:45 Coffee Break
11:15 Assessing Alternatives to In-Vivo testing: Changing the Paradigm from In-Vivo to In-Vitro Toxicology – Dr. Christian Pellevoisin (Scientific Director at Episkin Academy, L’Oréal)
11:45 The need to Identify “Unknowns” from a Risk Management Perspective – Ron Brown (ex-FDA; now Director at Risk Science Consortium LLC)
12:15 Lunch
13:30 How to select a CRO for Chemical Characterization Testing – Dr Dennis Jenke (Principal Consultant Nelson Labs Europe)
14:00 Most Common Types of Observations in Regulatory Submissions of Chemical Characterization Results and how to address them – Dr. Piet Christiaens (Scientific Director at Nelson Labs Europe)
14:30 Break
15:00 Intro The Processing Cycle – Henry Sibun (Henry Sibun Associates Ltd)
15:15 Sterilization of your Medical Device – Annick Gillet (Technical Director EO Pharma – Sterigenics)
15:45 Reprocessing Validations of reusable Medical Devices (part 1) – Dr Lise Vanderkelen (Department Head Micro & Pharma Services Nelson Labs Europe)
16:15 Reprocessing Validations of reusable Medical Devices (Part 2) – Alpa Patel, Principal Scientist (Nelson Laboratories LLC)
16:45 Q&A (panel)
17:00 End of Seminar Day 2 – tour of the laboratory facility on-demand
*Times and topics subject to change
Direct link to Nelson Labs Seminar page:
www.nelsonlabs.com/