2nd Annual Extractables & Leachables

Online Conference 2021

7th-8th of October 2021

BigMarker platform

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

2-DAYS ONLINE CONFERENCE INCLUDES

  • 10+ different topics
  • panel discussion
  • networking with business professionals and industry experts
  • additional materials
If you would like to participate, kindly book your spot. The seats are limited.
Broadcast Link will be provided via email post registration.

Event Schedule

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

Jason Creasey
Managing Director
Maven E&L Ltd
Andreas Nixdorf
Team Manager / Business Development Manager R&D
SGS INSTITUT FRESENIUS GMBH
Stephanie Volk
Senior Corporate Sterilization & Biocompatibility Specialist
ConvaTec
Nicholas Morley
Principal Scientist
Hall Analytical
Andrew Feilden
E&L European Strategic Director
Hall Analytical
Paolo Pescio
Senior Scientific Director
Eurofins
Russell Sloboda
Toxicology and Biocompatibility
DePuy Synthes
Dujuan Lu
SGS Institut Fresenius GmbH, Manager
SGS Health Science
Kaitlin Lerner
Executive Manager - Projects
Jordi Labs LLC

OUR PARTNERS

Contact Us

Maria Babenkova
Conference Producer
Tel.: +420 228 227 162
E-mail: mariia.babenkova@bcfgroup.eu
Valerie Neumann
Marketing Manager
Tel.: +420 228 227 162
E-mail: valerie.neumann@bcfgroup.eu