We are glad to announce we will be present at MedTech Summit 2021. The conference will be held virtually from 18-22 October.
Three of our Experts, Thor Rollins, Koen Van der Plas and Lise Vanderkelen, will be presenting:
The Current State of Biocompatibility: Where are we now?
Presenter: Thor Rollins, Toxicology and E&L Expert
Thursday, 21 October 2021 15:45 – 16:25 CEST (Cent Europe Summer, GMT+2)
With new and changing standards, MDR, and an increased emphasis on chemical characterization, biocompatibility looks a lot different today then 3 years ago. We will discuss what the FDA and Notified Bodies are asking in regard to biocompatibility. In this session, we will discuss:
- The status of E&L and regulatory acceptance and industry capacity
- In vitro alternatives and the new ISO 10993-23 standard
- How using pre-subs have changed during the pandemic
- The new draft of biocompatibility of skin contacting materials
Chemical characterization based on the new ISO 10993-18: the basics, interesting case studies and how chemical characterization can help in fulfilling the justification and labelling requirements of CMR/ED substances as specified in section 10.4 of the MDR.
Presenter: Koen Van der Plas, Study Director Medical Devices (E&L)
Friday, 22 October 2021 15:00 – 15:40 CEST (Cent Europe Summer, GMT+2)
In this presentation the overall set-up of a chemical characterization study based on the new ISO 10993-18 will be explained in detail from the selection of extraction solvents and conditions to the detection, identification, and quantification of the generated extractables. An industry case study of a chemical characterization study will be presented to clarify these concepts. Furthermore, the presentation will also show how a chemical characterization study can help as a first indicator in the justification and labelling requirements of CMR/ED substances as specified in section 10.4 of the MDR. An industry case study following a stepwise approach will also be presented outlining this testing strategy.
When playing with drugs and devices , how do you win the “combined product” game?
Presenter: Lise Vanderkelen PhD, Pharmaceuticals and Microbiology Expert
Date to be announced
The frequent contact of patients with combined products, a concept that describes the joint use of drugs and devices, makes the assessment of the compatibility of a device with certain drugs a very important topic. This presentation talks about the necessity of a good relationship between the drug and the device for the benefit of the patient. Determining the compatibility of combined products includes many different aspects. All these aspects need to be in balance to establish a healthy relationship within the combined products and to avoid any danger that may harm a patient. The main topics which will be discussed are the challenges for in-use stability and extractables & leachables testing.