Program

In this session, the instructors will discuss the importance of a risk based approach for biological evaluations, as well as ideas on how to connect to the risk analysis and overall risk management process. This workshop will include group discussions and hands-on exercises guided by Arthur Brandwood and instructors from Limulus Bio.

Upon completion, attendees will be able to:

• Understand how ISO 10993-1:2018 connects to other processes
• Get example of the structure of a biological evaluation plan and report
• Understand what needs to be included due to the EU MDR

Course Leader: Arthur Brandwood, Lina Burman and Monica Grekula

In this session, the instructor will discuss the chemical characterization of materials and the evaluation steps to examine material composition information and choose proper tests, extracts and test durations to meet the latest industry requirements. This workshop will include instruction and hands-on exercises guided by an experienced NAMSA instructor.

Upon completion, attendees will be able to:

• Discuss ISO 10993-18:2020 in a practical use format
• Develop a testing strategy for multiple device types
•  Evaluate material composition information and identify possible challenges with testing implementation
• Solve problems that may occur during testing, such as a degraded sample
• Plan for challenging test articles such as liquids, gels or other soluble devices

Course Leader: Alexander Hermann, PhD

Alexander holds a Master’s degree and a PhD from the University of Wuerzburg and started his career at NAMSA in June 2020 as a chemist in the Study Director Team in Germany. Shortly after, he took over as group leader and became Supervisor of the Study Director Team in September 2021. He has specific expertise in Chemical Characterization programs based on ISO 10993-18, as well as USFDA and other country expectations for the development of Study Designs and Chemical Characterization testing.

In this session, the instructor will discuss the conduct of toxicological risk assessments to evaluate chemical information, utilizing current and upcoming approaches for gathering toxicology data (both actual and predicted), estimating exposure, and evaluating toxicological risks. This workshop will include instruction and hands-on exercises guided by Sherry Parker (Senior Director of Regulatory Toxicology at WuXi AppTec), who isan experienced WuXi AppTec instructor.

Upon completion, attendees will be able to:

• Understand critical aspects of toxicological risk assessments and next steps to mitigate risk
• Learn about the upcoming changes to ISO 10993-17 (including useful tools) and the impact on current toxicological risk assessment processes
• Avoid common pitfalls, and meet regulatory expectations

Course leader: Sherry Parker, PhD

Dr. Parker has over 25 years of toxicology and medical device experience. After receiving her Ph.D. in Molecular and Cellular Pharmacology from the University of Miami, Dr. Parker worked as a toxicologist for the US EPA, RTI International, OrbusNeich Medical, and Fresenius Medical Care. In her current position she is the Senior Director of Regulatory Toxicology at WuXi AppTec. Dr. Parker is the US co-chair of the AAMI/ Biological Evaluation (AAMI/BE) Committee, and an ISO expert of the working groups for ISO 10993-1 and ISO 10993-17.

To round up the training day and kick of the conference we invite all participants to Hey IDA, a bar at Kalveboden Pier in connection to IDA conference center.

Take the opportunity to mingle with like minded!

*Snacks and beverages at Hey IDA is not included in the training day or conference ticket