PDA EU00175 Extractables and Leachables for Parenteral Applications Series

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When making parenteral drug products, pharmaceutical companies are faced with the regulatory requirements to further investigate the materials that will be in contact with the drug product either during manufacturing, intermediate storage, storage in its final packaging, or during the delivery of the drug to the patient. While historically, the potential safety issues were the main driver in these kinds of investigations; recently, quality issues, i.e. for biopharmaceuticals, have become an additional concern.

This education series (pre-recorded webinars combined with live discussions at the end of each day) will look at Extractables and Leachables (E/L) from many different angles:

  • Regulatory Requirements and Guidelines
  • Materials and Polymer Science
  • Mechanisms of Leaching and Material-Drug Product Interaction
  • Analytical E/L Methodologies
  • E/L Study Design for Different Packaging Systems
  • Large Volume Parenterals
  • Lyophilization Applications

Several interesting case studies on the above topics will also be presented.

At the end of each day, trainers are available to answer questions in a Live Q&A session.

Upon completion of this training course, you will be able to:

  • Explain in detail the current regulatory requirements for container/closure qualification form an E/L perspective.
  • Explain the upcoming changes in regulations, standards and recommendations from PQRI, USP and BPOG and how these changes could impact a future evaluation of a pharmaceutical C/C-system.
  • Understand the materials of construction – and their composition – of container closure systems, and how they could impact the safety and quality of a parenteral drug product.
  • Put together an evaluation program (review of provided documentation, analytical testing) of different types of parenteral drug product container/closure systems.
  • Perform a safety/risk assessment of analytical results, obtained after completion of an E/L study

Standard Pricing

Standard Member Price


GovernmentMember Only


Health AuthorityMember Only


Early Career ProfessionalMember Only


StudentMember Only


AcademicMember Only




See Qualifying Criteria for Member Types.


WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Monday, 8 November 2021

Session 1: Introduction - Helicopter View - Setting the Stage
Dennis Jenke

Session 2: Polymers 101 and Mechanism of Leaching
Piet Christiaens

17:00 – 18:00

Day 2

Tuesday, 9 November 2021

Session 3: Analytical and Toxicology 101
Dries Cardoen and Kevin Breesch

Session 4: Do’s & Don’ts Extractables and Leachables
Dries Cardoen

17:00 – 18:00

Day 3

Wednesday, 10 November 2021

Session 5: Single Use Systems – Biodisposables and Simulation Studies LVP
Karen Pieters and Dennis Jenke

Session 6: Small Volume Parenterals – Rubbers, Lyo Applications, Combination Products
Piet Christiaens

17:00 – 18:00

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