Informa

Industry Landscape

Extractables and Leachables (E&L) has become crucial aspect in the pharmaceutical industry due to stringent regulatory guidelines for increased patient safety. The pharma E&L testing market is expected to expand at a compound annual growth rate of 12.1% from 2015 to 2020. This growth is driven by the increasing adoption of single-use technologies and rigorous inspections by regulatory agencies. CRO'S are also evolving as development partners thereby further expanding the need for E&L studies. Emerging markets such as India and China are becoming hubs for contract manufacturing for such services, as these countries are building strong local expertise in analytical laboratory testing.

About Pharma Extractables & Leachables Forum

Examining extractables and leachables is an important safety issue as these substances can adversely impact the health of patients. In the recent years regulatory bodies have been increasingly focusing on the migration of mobile chemical substances from plastic components used in the packaging and manufacturing processes of pharmaceutical products.


The Pharma Extractables and Leachables Forum organized by CPhI Conferences will enable the audiences to Identify, analyze and assess them during R&D formulation stage, manufacturing process and ensuring right packaging. Leading Global E&L Experts and Toxicologist will share insights on the guidelines and recent updates on analytical and validation method testing innovations, and the impact of E&L. This is a perfect platform for professional to build a strong foundation for successful E&L Studies.


Key Topics

  • Challenges of E&L.
  • E&L testing methods in pharmaceutical products.
  • Best practices for deriving health-based exposure limits for E&L compounds.
  • Assessing product packaging safety.
  • The digital era: transformation in E&L assessment.

Pharma E&L 1st edition glimpses