3rd Annual Extractables & Leachables Hybrid Conference

1st-2nd of December 2022, 09:00 CET

Berlin

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ABOUT CONFERENCE

We are delighted to invite you to the 3rd Annual Extractables & Leachables Hybrid Conference, which will take place on the 1st – 2nd of December 2022 at 09:00 CET in Berlin, Germany and online on the BigMarker platform.

The 3rd Annual Extractables & Leachables Hybrid Conference will gather leading experts and researchers from Medical Devices industry who are keen to share their knowledge and discuss Rapidly Advancing Technologies and Latest Trends & Innovations in Toxicology & Medical Devices sectors.

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 as well as a panel discussion with some of the keynote speakers.

Platinum Sponsor

MEDIA PARTNER

Key points

  • E & L Practices: Chemical Characterization; Toxicological Risk Assessment; Material Characterization
  • E & L Compounds Analysis: Screening Methods; High Resolution Mass Spectrometry Technology Usage; Managing Unknown Compounds
  • Regulatory Considerations: ISO 10993-18 Updates; FDA Guidance; ISO 10993-17:2022

  • Medical Device Evaluation: TTC Application; AET Establishing Considerations; Challenges With E & L
  • Advanced E & L Testing Techniques: Small Molecule Identification Methods Analytical Workflow for E & L Testing; Multi-detector Strategy for Reducing Response Factor Variation

Who should attend

SVPs, VPs, Directors & Heads, Team Leaders, Engineers & Scientists,
Specialists, Managers & Consultants from:

  • Bioprocessing
  • Container Development
  • Device Engineering Extractables
    & Leachables/E&L
  • Materials Science & Selection
  • Manufacturing Science & Technology
  • Marketing & Business Development
  • Product and Process Development
  • Medical Devices
  • Global Sales & Business Development
  • Product Development

  • CQ
  • R & D
  • QA/QC
  • Safety & Risk Assessments
  • Standardisation
  • Testing
  • Toxicology
  • Analytical Chemist
  • Pharmaceutical Analysis
  • Regulatory Affairs
  • Innovation

2-DAYS Hybrid CONFERENCE INCLUDES

  • 11+ 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 & ACQUAINTANCE

9.00 – 9.10 CET

OPENING REMARKS

9.10 – 9.30 CET

SPEED NETWORKING

9.30 – 9.40 CET

WELCOME & OPENING REMARKS FROM THE CHAIRMAN, CET OPENING REMARKS FOR ONLINE DELEGATES

9.40 – 10.20 CET

TBA + Q&A

10.20 - 11.00 CET

Screening & Control of Extractables & Leachables – An Analytical Approach + Q&A

11.00 – 11:15 CET

Coffee break

11.15 – 11:55 CET

Regulatory Expectations of ISO 10093-18 in Study Design + Q&A

11:55 - 12:35 CET

Extractables and Leachables Assessments in Pre-Filled Syringe (PFS) Drug Products + Q&A

12:35 – 13:35 CET

Lunch

13:35 – 14:15 CET

The ISO 10993-12 Extraction Conditions Round Robin + Q&A

14:15 – 14:55 CET

Comparison of the Levels of Rubber Stopper-Related Organic Leachables in Commercially Available Vialed Liquid and Lyophilized Drug Products + Q&A

14:55 – 15:35 CET

When Chemical Characterization Meets MDR - How to Integrate the Extractable & Leachable Study & Toxicological Evaluation into the Overall Biosafety Strategy + Q&A

15:35 – 16:15 CET

Critical substances in Medical Devices – Current Requirements & How to Overcome Typical Hurdles in the Toxicological Evaluation + Q&A

16:15 – 16:20 CET

Closing remarks

19:00 – 21:00 CET

Dinner and Cocktail

09:00 – 09:30 CET

Registration and welcome drink

09:30 – 09:40 CET

OPENING REMARKS FROM BCF REPRESENTATIVE

9.40 – 9.50 CET

WELCOME & OPENING REMARKS FROM THE CHAIRMAN, OPENING REMARKS FOR ONLINE DELEGATES

9.50 – 10:30 CET

Session 1: Medical Device Evaluation + Q&A

10:30 – 11:10 CET

TBA + Q&A

11:10 – 11:25 CET

Coffee Break

11:25 – 12:05 CET

Session 2: Advanced E & L Testing Techniques + Q&A

12:05 – 12:45 CET

Experimental Design Considerations For Extractable & Leachable Studies + Q&A

12:45 – 13:00 CET

CLOSING REMARKS

13:00 – 14:00 CET

Lunch

SPEAKERS

OUR PARTNERS

Contact Us

Maria Babenkova
Conference Producer
Tel.: +420 228 227 163
E-mail: mariia.babenkova@bcfgroup.eu
Valerie Neumann
Marketing Manager
Tel.: +420 228 227 162
E-mail: valerie.neumann@bcfgroup.eu
Daria Novoseltseva
Business Development
Tel.: +420 228 227 163
E-mail: daria.novoseltseva@bcf-events.com