2nd Annual Extractables & Leachables

HYBRID Conference 2021

7st-8nd of October 2021, 15:00 CET

BigMarker platform

ABOUT THE CONFERENCE

We are delighted to invite you to 2nd Annual Extractables & Leachables hybrid Conference 2021, which will take place in Barcelona, Spain on the 7st-8nd of October 2021.

Join us for an event which 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 newest strategies in 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 Medical Devices industry.

Key points

  • Regulatory Considerations
  • Do You Need
  • Leachables & Extractables
  • in Polymers
  • The Use of Analytical Chemistry
  • E&L Testing & Launch
    of New Medical devices
  • Analytical Considerations
    in Extractable & Leachable Studies
  • Application of the Threshold
    of Toxicological Concern
  • ISO 10993-18:
    Key Concepts & Practices
  • Following New Principles
    of ISO 10993-17
  • Challenges with Extractables
    & Leachables
  • Common Mistakes in E&L
  • Determine Patient Exposure
    to Medical Device
  • Considerations in Establishing
    an AET
  • 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

3-HOUR ONLINE CONFERENCE INCLUDES

  • 4+ 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

8:30 – 9:00 CET

REGISTRATION & WELCOME DRINK

9:00-9:20 CET

OPENING REMARKS FROM THE CHAIRMAN

9:20-9:50 CET

SPEED NETWORKING

9:50-10:20 CET

WHAT REGULATORY CONSIDERATIONS DO YOU NEED TO ENSURE COMPLIANCE

10:20-10:30 CET

Q&A Session

10:30-11:00 CET

Networking Coffee Break

11:00-11:30 CET

DETERMINE LEACHABLES AND EXTRACTABLES IN POLYMERS

11:30-12:00 CET

THE USE OF ANALYTICAL CHEMISTRY IN MEDICAL DEVICE SAFETY ASSESSMENTS

12:00-12:20 CET

Q&A Session

12:20-13:30 CET

Lunch & Networking

13:30-14:00 CET

E&L TESTING WILL HELP TO GET NEW MEDICAL DEVICES TO LAUNCH SUCCESSFULLY

14:00-14:30 CET

ISO 21726: BIOLOGICAL EVALUATION OF MEDICAL DEVICES — APPLICATION OF THE THRESHOLD OF TOXICOLOGICAL CONCERN

14:30-14:50 CET

Q&A Session

14:50-15:20 CET

Networking Coffee Break

15:20-15:50 CET

ISO 10993-18: KEY CONCEPTS AND PRACTICES FOR AND COMPLIANT CHEMICAL CHARACTERIZATION

15:50-16:20 CET

MEDICAL DEVICE TOXICOLOGICAL RISK ASSESSMENT FOLLOWING NEW PRINCIPLES OF ISO 10993-17

16:20-16:50 CET

PANEL DISCUSSION: CHALLENGES WITH EXTRACTABLES AND LEACHABLES IN MEDICAL DEVICES

16:50-17:20 CET

Q&A Session

17:20-17:30 CET

Closing Session Remarks

19:00-21:00 CET

EVENING COCKTAIL RECEPTION

8:30 – 9:00 CET

Registration & Networking

9:00-9:10 CET

OPENING REMARKS FROM THE CHAIRMAN

9:10-9:40 CET

COMMON MISTAKES IN E&L

9:40-10:10 CET

ANALYTICAL CONSIDERATIONS IN EXTRACTABLE AND LEACHABLE STUDIES OF MEDICAL DEVICES PER ISO 10993-18:2020

10:10-10:30 CET

Q&A Session

10:30-11:00 CET

Networking Coffee Break

11:00-11:30 CET

HOW TO DETERMINE PATIENT EXPOSURE TO MEDICAL DEVICE LEACHABLES

11:30-12:00 CET

Q&A Session

12:00-13:00 CET

LUNCH TIME & NETWORKING

13:00-13:30 CET

IMPLEMENTING 10993-18: CONSIDERATIONS IN ESTABLISHING AN AET FOR CHEMICAL CHARACTERIZATION OF MEDICAL DEVICES

13:30-14:00 CET

HOW TO EVALUATE DIFFERENT CLASSES OF CHEMICALS DETECTED FROM EXTRACTABLES AND LEACHABLES ANALYSES

14:00-14:30 CET

Q&A Session

14:30-14:50 CET

Closing Session Remarks

Contact Us

Kara Koz
Conference Producer
Tel.: +420 228 227 163
E-mail: kara.koz@bcf-events.com
Valerie Neumann
Marketing Manager
Tel.: +420 228 227 162
E-mail: valerie.neumann@bcfgroup.eu
Benazir Jursunbek
Operations and Conference Manager
Tel.: +420 228 227 164
E-mail: operations@bcf-events.com