2021 ISPE Pharma 4.0™ and Annex 1 Conference

Important Notice: 2021 ISPE Pharma 4.0™ and Annex 1 Conference Postponed to 7-8 December 2022

On 19 November, Austria announced a full national Covid-19 lockdown starting on Monday, 22 November until 12 December, including shutdown of all non-essential businesses, including hotels. Based on discussions with representatives from the host hotel for the upcoming 2021 ISPE Pharma 4.0™ and Annex 1 Conference, this effectively makes it impossible to hold the event as planned. As such, following careful consideration, ISPE has made the difficult decision to postpone the 2021 ISPE Pharma 4.0™ and Annex 1 Conference until 7-8 December 2022, at the same venue in Vienna, Austria.

This signature event has an impressive lineup of international speakers slated to speak in-person with opportunities to connect with them directly during special networking opportunities, including a Networking Dinner as well as local plant tours. Therefore, it is in the best interest of event stakeholders and attendees to reschedule for 2022 to facilitate a truly beneficial and collaborative educational program for all.

For further inquiries, please contact ISPE Member Services at ask@ISPE.org.

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

What to Expect

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Why Attend the 2021 ISPE Pharma 4.0™ & Annex 1 Conference

  • How to successfully prepare Aseptic Operations
  • How to unlock opportunities given by Digitisation
  • How to approach Pharma 4.0™
  • Learn from COVID-19 challenges
  • Engage with peers, regulators, and specialists
  • Take back real implementation strategies to your workspace

Who Should Attend

  • Developers, Manufacturing and Engineering professionals involved in or interested in understanding the current state of digitalisation
  • Suppliers
  • Quality Assurance and Regulatory professionals
  • Process and Project Engineers
  • Regulators
  • Academia
  • Stakeholders of the Vaccination value chain 
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, Consultant, 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
Nuha Al-Hafez
Head Of Connected Health
Merck Healthcare KGaA
Thomas Lee Johnson, CEO
CEO & Founder
Agile Immersive
Josef Trapl
Head of MSci Innovation, GMS / Manufacturing Science
Takeda Pharmaceutical International AG
Yvonne M. Duckworth, PE
Sr Automation Engineer / Pharma 4.0 SME
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

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