The 2021 ISPE Pharma 4.0™ and Annex 1 Conference will bring together leading pharmaceutical and biopharmaceutical manufacturers, technology providers, academic scientists, and international regulators to network, share insights and provide an outlook on the evolving landscape and future of Pharma 4.0™ supported Aseptic Manufacturing.

The conference will provide a leading interdisciplinary platform for all stakeholders of the pharmaceutical chain. This platform will showcase recent innovations and trends, and directly discuss practical challenges and solutions, from a technical, logistical, and regulatory perspective. The impact of upcoming regulations, in particular for Annex 1, will be integrated throughout the conference programme and panel discussions. Participants will have the opportunity to engage with industry leaders, regulators, and peers through networking events and the conference programme.

The key focus themes will include, but are not be limited to:

• Pharma 4.0™ and the Contamination Control Strategy, Environmental Monitoring, and Rapid Microbiology Testing
• How to maximise productivity by using closed systems and disposables
  
  • Annex 1 implementation within GXP compliance and cost containment
• Quality 4.0 and Aseptic Processing: Predictive Data Analysis, Data Science, and Process Science
• Industry Trends and Regulators’ Expectation
• Pharma 4.0™ Roadmap for implementation
  
  • Lighthouse projects and Automation Islands to a Corporate Approach
  • Case Studies, Augmented Reality, Connected Health
• Digital Maturity, Barriers and Success Factors
• Modelling and Controlling of a Holistic Control Strategy
• Robotics and Pharma 4.0™ supporting Technologies