Biological Safety Training – Berlin

Description

In-person training in English

Course A: Biocompatibility of Medical Devices
Two-Day Certification Course

Date: March 24-25, 2025
Location: The Westin GRAND BERLIN
Price: $2,150 USD (early registration discount of $1,800 USD ends Sunday, February 9, 2025)
Agenda: NAMSA-Course-A-Agenda-Berlin_2025 (Monday reception: networking with attendees and speakers, appetizers)

The release of ISO 10993-1:2018, 10993-18:2020 and the Medical Device Regulation (MDR) General Safety and Performance Requirements (GSPR) bring several challenges for medical device manufacturers. The industry is experiencing the most drastic updates in the biological evaluation of medical devices since the issuance of the ISO 10993 standards.

This course is structured to tackle each of these challenges and provide hands-on experiential learning. It is designed for those who require a working knowledge of biocompatibility or are looking to update and sharpen their skills. Participants can expect to learn how to use standards to establish a biological safety evaluation plan, as well as how to document and implement their plan. Use of material/chemical characterization and risk assessment will be highlighted, as will real-world exercises to practice evaluating biological risk. (In order to be certified as a Biological Safety Specialist, participants must attend and complete all exercises over the 2-day course).

Course Objectives

Upon course completion, attendees will be able to:

• Apply the principles of ISO 10993-1:2018 to attendee’s particular challenges with medical device biocompatibility
• Discuss the FDA guidance for biological safety and distinguish where the FDA and other regulatory bodies differ
• Prepare to upgrade device technical documentation to meet the European Union’s (EU) MDR 2017/745 GSPR
• Answer the question: When is testing not the only option?
• Distinguish the difference between evaluation and testing and recognize when testing is absolutely necessary or avoidable
• Select chemical and biological tests and understand how to choose among various methods
• Utilize ISO 10993-18:2020 and material/chemical characterization information with the use of toxicological risk assessment to demonstrate biological safety
• Develop a program that guides your device on the regulatory path and reduces time to market
• Practice how to execute your plan from development to completion and how to schedule and document the implementation of your biocompatibility plan

Register for both Course A & Course B and Save!

March 24-27, 2025 $3,650 USD (early registration discount of $2,950 USD ends Sunday, February 9, 2025)

Course B: Continuing Education for the Biological Safety Specialist

Prerequisite: Course A: Biocompatibility of Medical Devices – Two-Day Certification
Date: March 26-27, 2025
Location: The Westin GRAND BERLIN
Price: $2,150 USD (early registration discount of $1,800 USD ends Sunday, February 9, 2025)
Agenda: NAMSA-Course-B-Agenda-Berlin_2025

This two-day training course is designed for those who have received certification to the NAMSA Training Series Biocompatibility of Medical Devices – Two-Day Certification Course. Objectives of this course include practice beyond the basics of Table A.1 in ISO 10993, with increased practical application and updated workshops. In addition to traditional medical devices, we will address combination products and resorbable materials. Participants will not only learn how to assess their device for biological risks, but also understand when testing is not necessary.

Utilizing ISO 10993-17, attendees will actively calculate toxicological thresholds with practical chemical characterization data. Additionally, instructors will provide an opportunity to work with real-world medical device case studies  and provide solutions and an understanding of how to present data in a submission during the hands-on workshops. Participants will walk away with the knowledge of how to plan a strategy to endure potential obstacles.

Course Objectives

Upon course completion, attendees will be able to:

• Distinguish global regulatory expectations for biological safety
• Review reports for accurate data and understand when to work with a laboratory when unexpected results are reported
• Evaluate complexities for drug/device combination devices
• Calculate toxicological thresholds for cancer, chemical mixtures and assessment of unidentified chemicals
• Apply skills gained from two real-life exercises to calculate toxicological thresholds and experience testing errors and how to mitigate them, as well as manage a device from concept to market clearance

Register for both Course A & Course B and Save!
March 24-27, 2025 $3,650 USD (early registration discount of $2,950 USD ends Sunday, February 9, 2025)

NOTE: Our security measures require that your credit card billing address match your profile address.

Speakers

Sylvie Framery, PhD, Senior Principal Biological Safety Scientist, NAMSA

Sylvie joined NAMSA in 2000 as Study Director, where she focused on all types of In Vivo normative studies, including reprotoxicity and carcinogenicity studies. Since that time, Ms. Framery has joined NAMSA’s Consulting Group to provide regulatory consulting services to manufacturers on biocompatibility projects to support worldwide market approval.

Full biography here

Alfred Dibao-Dina, PhD, Biological Safety Scientist, NAMSA

Alfred holds a PhD in Microelectronics Applied to Biology, also known as Bioelectronics. At NAMSA since 2017, his current role as a Biological Safety Scientist focuses on writing and reviewing Biological Evaluation Plans and Reports per ISO 10993-1 and ISO 14971 and Toxicological Risk Assessments per ISO 10993-17. He provides regular trainings on behalf of NAMSA, and helped with the qualification and validation of NAMSA’s chemistry laboratory in Germany.

Full biography here.

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