Inhouse training - Infarmed 28 November 2017

Infarmed Regulatory training

28th November 2017, Lisbon, Portugal

Chair: Andrew Thornley, Regulatory Training Manager, TOPRA

09:15 Registration

Tea and Coffee

09:30 Welcome from TOPRA and outline of the day – Andrew Thornley

09:40 Introductions from course delegates and what they wish to get out of the day

09:45 Catherine TREMOLIERES, DVM Manager, EU Biological Safety and Validation Consulting Services, NAMSA

Evaluation and Testing Within a Risk Management Process (ISO 10993-1)

10:45 Tea/Coffee break


Sample Preparation and Reference Materials (ISO 10993-12)

Chemical Characterization (ISO 10993-18) : purpose and methods

Interactive Exercise

12:00 Lunch


Biological Tests: purpose and methods Cytotoxicity (ISO 10993-5) Irritation (ISO 10993-10) Sensitization (ISO 10993-10) Systemic toxicity (ISO 10993-11) Genotoxicity (ISO 10993-3)

14:30 Coffee/Tea break


Biological Tests: purpose and methods (con’t…) Implantation (ISO 10993-6) Hemocompatibility (ISO 10993-4)

16.15 Summary and Q&A Session

16:45 Close of day

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