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Eurofins Czech >> Biopharma Product Testing >> E&L workshop

Extractables and Leachables and Container Closure Integrity Testing Workshop

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Ensuring the safety of your drug product throughout its entire lifecycle is becoming increasingly complex. As regulatory expectations continue to evolve, assessing substances that may leach from packaging materials into your product is more critical than ever. These substances can migrate from various materials and expose patients through different routes of administration, potentially impacting product safety, stability, and efficacy.

Our workshop is designed to support you in navigating these challenges. You will gain practical insights into pharmaceutical packaging testing and learn how to implement effective strategies that help you safeguard your products and meet regulatory requirements with confidence.

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  • Regulatory requirements and expectations on E&L
  • How to prepare a successful E&L study
  • Practical approaches for E&L testing
  • Evaluation of E&L data
  • Toxicological assessment
  • E&L testing for single-use systems and primary packaging
  • Container Closure Integrity Testing (CCIT)
  • Francesco Tessari – E&L Technical Business Manager, Eurofins BioPharma Product Testing Italy
  • Daniele Zarini – E&L Technical Business Manager, Eurofins Regulatory & Consultancy Services Italy Srl
  • Carlo Bidoia – Business Developer, Eurofins BioPharma Product Testing Italy

Topic

Speaker

Time (min)

Intro - E&L as Center of Excellence

C.Bidoia

15

E&L Regulation Overview and Risk based approach

D.Zarini

45

Extractables Assessment and Toxicological Evaluation

F.Tessari

45

Coffe break

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Leachables study design

F.Tessari

15

Case Study (Large molecule)

F.Tessari

15

Quiz Session (mentimeter)

D.Zarini and F.Tessari

15

Closing and Q&A

Everyone

15

Date: 16th June 2026

Time & Location: 1:30 – 4:30 PM, PCI Days Warsaw at EXPO XXI (Hall nr 1 and Hall nr 3) Ignacego Prądzyńskiego 12/14 Str., 01-222 Warsaw, lecture room

Registration Fee: Free

Workshop Language: English