2022 ISPE Pharma 4.0™ and Annex 1 Conference

The 2022 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.

New Annex 1: Are You Ready?

The 2022 ISPE Pharma 4.0™ and Annex 1 Conference is the must-attend conference to understand the revisions of the EU GMP Annex 1, Manufacture of Sterile Medicinal Products before implementation next year. Comments by ISPE and our members were included in the final document, and those stakeholders will be leading discussions and sharing important insights throughout the conference.

Gain first-hand knowledge on:

  • The officially released version of Annex 1 and its interpretation
  • Case studies showing how contamination control strategy is best implemented
  • How retrofitting and optimisation projects are being approached (e.g., for lyophilizer loading/unloading)
  • And more!

Don't miss this chance to better understand the revisions and how Pharma 4.0™ concepts can assist with implementing Annex 1.

Register Today!

Featured Sessions

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Featured Speakers

What to Expect

Take Advantage of Vienna in December!

During this year's conference, you'll have the chance to take advantage of the stunning Christmas markets around the city of Vienna while you warm yourself with glühwein, lebkuchen, punsch, and experience the quintessential Austrian gemütlichkeit.

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Take Advantage of Vienna in December

Explore the Education Tracks

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Key Conference Topics

  • 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
  • Pharma 4.0™ Enabling Technologies

Conference Highlights

ISPE Safety Precautions

Robust risk mitigation measures are being undertaken to instill public confidence in the safety of ISPE’s in-person events. In conjunction with the venues and vendors supporting our conference, we will follow health and safety measures issued at the time of the events by state and local authorities, with consideration of CDC guidance, to minimize the spread of COVID-19 and ensure the health and safety of our event participants.

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Program Committee

Jörg Zimmermann
Vice President, Vetter Development Service, External Affairs
Vetter Pharma-Fertigung GmbH & Co.
Christian Woelbeling
Executive Industry Advisor
Richard Denk
Senior Consultant Aseptic Processing & Containment
Jean-Francois Duliere
Pharmaceutical Senior Expert, Vice Chair ISPE France Affiliate
Heike Roeder
Director, Lead Digital Quality, Risk Advisory Life Science
Thomas Zahel, PhD
Head of Innovation
Placeholder Person Graphic
Karine Peron
Head of Technology Management - EMEA
Merck Millipore
Josef Trapl
Head of MSci Innovation, GMS / Manufacturing Science
Takeda Pharmaceutical International AG
Yvonne Duckworth, PE
Fellow - Digital Technology, Associate
Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
Wolfgang Winter
Director, Informatics Platform R&D
Agilent Technologies R&D Mktg GmbH & Co KG
Bernd Boedecker
Ex-EU GMP Inspector
GMP Freelance Consultant

Media Partners

IPQ media partner
The Medicine Maker media partner