Key Initiatives in Europe

The Key Initiative working groups report to the European Leadership Team (ELT)

Pharma 4.0 Special Interest Group (SIG)

The SIG is defined in the following subgroups:

  • Pharma 4.0 Roadmap / Application of the ICH Q10 Elements
  • Impact & Maturity Model of Pharma 4.0
  • Data Integrity by Design: Process Maps, Process Data Maps, Critical Thinking
  • Continuous Process Verification/CPV & Process Automation

Biotech Special Interest Group


Our vision is to deliver solutions with tangible results and practical application to the biopharmaceutical industry in Europe, to significantly widen patient access and deliver real value to its stakeholders – making biologics more affordable.


We deliver our vision i.e. technical and operational solutions by:

  • Fostering global connectivity between regulators and biotechnology industry leaders and experts in diverse events’ formats
  • Connecting and engaging the biotechnology experts in exchanging practices, problem statements and working out industrial solutions in the frame of current and upcoming regulations
  • Engaging members to share, present and document industry solutions through the ISPE as a platform for the benefit of all ISPE affiliates and their stakeholders
  • Facilitate disruptive and incremental innovation in biologics development & manufacturing