ABOUT THE CONFERENCE
We are delighted to invite you to the 2nd Annual Extractables & Leachables Conference 2021, which will take place online 7th-8th of October 2021 at 14:00 CET on the BigMarker platform.
Join us for an event that offers a meeting place for top manufacturers, researchers, academics, decision-makers, and other business professionals who are keen to share their knowledge and experience in the newest strategies in the Medical Devices industry and opportunities for further development.
The conference represents a unique opportunity for learning, exchanging opinions, and expanding one’s network-enabled by live presentations followed by dynamic Q&A sessions – providing the attendees with valuable insights from specialists in the sphere of the Medical Devices industry.
Key points
- Regulatory Considerations Do You Need
- Leachables and Extractables in Polymers
- The Use of Analytical Chemistry
- E&L testing and launch of new medical devices
- ISO 10993-18: Key Concepts and Practices
- Following New Principles of ISO 10993-17
- Analytical Considerations in Extractable
and Leachable - Common Mistakes in E&L
- Determine patient exposure
medical device - Considerations in Establishing an AET
- Challenges with Extractables and Leachables
- Evaluate different classes
of chemicals detected
Who should attend
SVPs, VPs, Directors & Heads, Team Leaders, Engineers & Scientists, Specialists, Managers and Consultants from:
- Bioprocessing
- Container Development
- Device Engineering Extractables and Leachables/E&L
- Materials Science and Selection
- Manufacturing Science and Technology
- Marketing & Business Development
- Product and Process Development
- Medical Devices
- Global Sales & Business Development
- Product Development
- CQ
- R&D
- QA/QC
- Safety and Risk Assessments
- Standardisation
- Testing
- Toxicology
- Analytical Chemist
- Pharmaceutical Analysis
- Regulatory Affairs
14:00 – 14:05 CET
WELCOME AND OPENING REMARKS
14:05-14:30 CET
The Multidetector Strategy for Reducing Response Factor (RF) Variation in E&L Analysis + Q&A
14:30-14:55 CET
Introduction on Chemical Characterization According to New ISO 10993-18 (Medical Devices) + Q&A
14:55-15:05 CET
Coffee Break
15:05-15:30 CET
Uncertainty Factors - Points to Consider to Achieve Quantification + Q&A
15:30-15:55 CET
ISO 21726: Biological Evaluation of Medical Devices - Application of the Threshold of Toxicological Concern + Q&A
15:55-16:05 CET
Coffee Break
16:05-16:30 CET
Pending (Potential) Updates to ISO 10993-17 + Q&A
16:30-16:55 CET
PANEL DISCUSSION: Challenges with Extractables and Leachables in Medical Devices
16:55-17:00 CET
CLOSING SESSION REMARKS
14:00 – 14:05 CET
Welcome and opening remarks from the Chairman
14:05-14:30 CET
Looking at Leachable Risk Management – Assessment and Control of Leachables + Q&A
14:30-14:55 CET
Planning and Implementation of a Leachable Shelf Life Study for Pharmaceutical Applications + Q&A
14:55-15:05 CET
Coffee Break
15:05-15:30 CET
Strategies to Ensure Optimal Use of the TTC in Toxicological Risk Assessment + Q&A
15:30-15:55 CET
Implementing 10993-18: Considerations in Establishing an AET for Chemical Characterization of Medical Devices + Q&A
15:55-16:05 CET
Coffee Break
16:05-16:30 CET
Managing Change in the Ever-changing World of Extractables & Leachables + Q&A
16:30-16:55 CET
PANEL DISCUSSION: Common Mistakes in E&L
16:55-17:00 CET
Closing session remarks from the Chairman
SPEAKERS
OUR PARTNERS
