Date(s) - 10/01/2019 - 10/02/2019
Elite Park Avenue
Join NAMSA at the 3rd Symbioteq Biocompatibility of Medical Device Conference in Göteborg, Sweden on 1-2 October. This event will include discussions regarding medical device requirements by regions, biocompatibility expectations under the EU’s Medical Device Regulation (MDR) and updates on ISO 10993. Whether you work within R&D, QA or Regulatory, don’t miss this unique opportunity to network with fellow medical devices biocompatibility professionals and learn more about immunotoxicology, In Vitro methods and chemical characterization.
NAMSA Educational Session: PK/TK/ADME and Particles in Medical Device Biocompatibility – When Should We Think About This?
Date/Time: 2 October 2019 | 9:50 AM
Presented by: Gaelle Clermont, Pharm D, PhD; Product Development Strategist, NAMSA
Pharmacokinetics (PK), Toxicokinetics (TK) and ADME (absorption, distribution, metabolism and elimination) are referenced in the EU’s Medical Device Regulation (MDR), ISO 10993-16 (Toxicokinetic study design for degradation products and leachables) and the FDA 2016 biocompatibility guidance.
These studies, which determine the biocompatibility of medical devices, can be of value in assessing the safety of materials used in the development of a medical device or in elucidating the mechanism of observed adverse reactions, however, these assessments are rarely seamless. This presentation discusses the situations where these particular studies may be required, the background and methodology for reaching endpoints and what difficulties/challenges may be encountered (radio-labelling, validating methods). Specific questions that will be addressed:
- Is the chemical absorbed (rate and degree)?
- Where are the chemicals and/or metabolites distributed in the body?
- How is the chemical metabolized (site and rate of metabolism and identification of metabolites)?
- What are the elimination rate and the elimination route(s) of the chemical and possibly its metabolite(s)?
- What is the effect of dose on absorption, distribution, metabolism and elimination?
In addition, this presentation will briefly discuss the GSPR 10.6 (particles) to determine when there may be possible risks, linked to the size and the properties of particles, following release into the patient/user. ISO 10993-1 (Evaluation and testing within a risk management process), ISO 18562-1 (Evaluation and testing within a risk management process), ISO 18562-2 (Tests for emissions of particulate matter) and the FDA 2016 Biocompatibility guidance all make reference to particles/particulates, so why should they be of concern and raise questions when they are seen? Examples are provided of toxicity effects, utilizing asbestos exposure via the inhalation route as a model, to show why the presence of particulates may be of concern when they have been mentioned in respective submission documents.
Throughout this event, NAMSA will have medical device development experts available for 30-minute complimentary consultations. We welcome the opportunity to discuss with you the most cost-effective pathway to market based on your unique commercialization goals. (Learn more about how a NAMSA partnership delivers time and cost savings for clients worldwide; click here.)
Please contact us at namsa.com/contact-us/ to reserve your consultation time.