2023 ISPE Pharma 4.0™ and Annex 1 Conference


The 2023 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.

Throughout this event, we'll be delving into key areas, exploring:

  • Pharma 4.0™ Integration: Discover how Pharma 4.0™ principles and digitalization transform operations, quality, and maintenance within the pharmaceutical landscape.
  • Annex 1 Implementation: Learn strategies for implementing the latest Annex 1 version through real-world case studies, ensuring smooth operational changes and hardware integration.
  • Automation: Dive into the impact of automation on cutting-edge processes like ATMPs and gene therapy, redefining how we work.
  • Rapid Monitoring and Testing: Uncover how rapid microbial monitoring enhances quality control precision and streamlines supply chains.
  • Expert Insights: Hear from industry leaders and regulators who will share their perspectives on the future of pharmaceuticals.

Keynote Speakers

Featured Topics 

Why Attend the 2023 ISPE Pharma 4.0™ and Annex 1 Conference?

Conference Highlights

Programme Committee

Cristina Mazo
QP - Site Manager
GP Pharma
Chair - Pharma 4.0
Jörg Zimmermann
Vice President Vetter Development Service External Affairs
Vetter Pharma Fertigung GmbH & Co KG
Chair - Annex 1
Nuha Al-Hafez
Quality Fundamentals Area Lead
Maria Amaya
Lead External Advocacy North America (Quality Policy)
Genentech, A Member of the Roche Group
Placeholder Person Graphic
Pol Bonet Sune
Talento-Ephos & UIC
Richard Denk
Senior Consultant Aseptic Processing & Containment
Yvonne Duckworth, PE
Fellow - Digital Technology, Associate
Jean Francois Duliere
Reg Advisor
Placeholder Person Graphic
Isabel Garcia Mora
Quality Assurance Project Manager
Lonza AG
Matthew P. Gorton
Director of Business Development
GBA Life Sciences
Felix Kern
Associate Director - Head of Compliance Launch and Technology Center
Merck KGaA
Line Lundsberg-Nielsen, PhD
Managing Consultant, Compliance Consulting
Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
Heike Roeder
Vice President QA International
Alicia Tebar
Founder. QbD & GMP Consultant
QbD Pharmaceutical Services SL
Josef Trapl
Head of Innovation in Life Science
Wolfgang Winter
Software Framework R&D Director
Agilent Technologies Deutschland GmbH
Christian Woelbeling
Executive Industry Advisor
Körber Pharma Software GmbH