2024 ISPE Pharma 4.0™ and Annex 1 Conference

Hear From Top Industry Thought Leaders on the Challenges and Solutions Impacting the Pharmaceutical Industry

Why attend?

Case Studies

Expert Insights

Hear from industry leaders and regulators who will share their perspectives on the future of pharmaceuticals.

Technical Presentation

Pharma 4.0 Case Studies & Lessons Learned

Deep dive into case studies of digital business transformation to understand the benefits, challenges, and lessons learned from implementing digital solutions.

Technical Presentation

Annex 1 Implementation & Pharma 4.0

Learn strategies for implementing the latest Annex 1 version through real-world case studies, ensuring smooth operational changes and hardware integration. 

Construction

Pharma 4.0 Interconnected Facility Design & Construction

Gain insight into how 'plug and produce' principles offer opportunities for creating an integrated and interconnected facility, but also come with their challenges.

Case Studies

How ATMPs Manufacturing can be Supported by Annex 1 & Digital Transformation

Discover how the pharmaceutical industry can ensure the delivery of safe products to patients by improving their processes, implementing Annex 1, and utilizing enhanced data management for faster product release.

2024 ISPE Pharma 4.0™ and Annex 1 Conference

The 2024 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 digital transformation, automation, and 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. These sessions and workshops will showcase recent innovations and trends, and directly discuss practical challenges and solutions, from a technical, logistical, and regulatory perspective. The impact of Quality Risk Management (QRM) and Contamination Control Strategy (CCS) regulations, in particular for Annex 1, will be integrated throughout the conference program and discussions. Participants will have the opportunity to engage with industry leaders, regulators, and peers through networking events and the conference program.

Featured Speakers

Independent Senior Advisor Biopharmaceuticals
Former Head of Biopharma Business Unit, Boehringer Ingelheim
SVP Head of Product Supply Fill & Finish Expansions
Novo Nordisk A/S
Senior Vice President Head of Global Engineering and Maintenance Excellence
Bayer
Head of Institute Surveillance
Austrian Agency for Health and Food Safety (AGES)

Your Conference Experience

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Expo Hall
Expo Hall
Explore groundbreaking innovations and network with industry leaders at our dynamic expo hall.
session-training
Professional Training
Professional Training
Connect with top industry experts and expand your professional network at our exclusive networking sessions.
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Live Streams
Live Streams
Experience the conference from anywhere with our interactive live stream.
2024 ISPE Pharma 4.0™ and Annex 1 Conference
Keynote Speakers
Keynote Speakers
Subject matter experts and top leaders in the pharmaceutical industry.

Conference Highlights

Digitization-Image by Gerd Altmann from Pixabay

Unlock the Future of Pharmaceutical Manufacturing: Learn from Industry Leaders at the 2024 ISPE Pharma 4.0™ and Annex 1 Conference

In an era where technological advancements are reshaping every industry, the pharmaceutical sector is no exception. The 2024 ISPE Pharma 4.0™ and Annex 1 Conference is the gateway to understanding and leveraging digital transformation and artificial intelligence (AI) in pharmaceutical manufacturing. This year, ISPE is bringing together global thought leaders from industry stalwarts like AstraZeneca, Bayer, BioNTech, Boehringer Ingelheim, Johnson & Johnson Innovative Medicines, Merck Serono S.P.A., Novo Nordisk A/S, and Takeda Austria GmbH. They will share their invaluable insights into their digitalization journeys, offering key learnings that can be directly applied to businesses.

Source-SKAN AG

Pharma 4.0™ and Annex 1 Implementation: A New Era for Aseptic Manufacturing

The pharmaceutical industry is in the middle of a transformative shift, driven by the dual forces of Pharma 4.0™ and the updated Annex 1 guidelines. These changes are introducing innovations that not only enhance the quality and safety of sterile manufacturing but also leverage new technologies to optimize efficiency and compliance. This track will bring together industry experts to discuss how Pharma 4.0 principles can support the implementation of Annex 1. From contamination control strategies to robotics and data-centric architectures, these sessions will provide attendees with actionable insights and solutions to stay ahead in an evolving regulatory landscape.

medical-banner-with-doctor-wearing-equipment

Exploring the Future of ATMP Manufacturing from Digitalization to Navigating Regulations

In an era where advanced therapy medicinal products (ATMPs) are revolutionizing healthcare, the 2024 ISPE Pharma 4.0™ and Annex 1 Conference, taking place 10-11 December in Rome, Italy, and virtually, will feature a track titled, "How ATMPs Manufacturing can be Supported by Annex 1 and Digital Transformation." This track will bring together experts from various fields to discuss the integration of digital technologies and regulatory frameworks in the development journey of ATMPs, as well as provide insights into real world implementation data and lessons learned. With a focus on enhancing compliance, efficiency, and accessibility, the track will feature six engaging talks and provide attendees with valuable insights into the future of this rapidly evolving sector.

ISPE Pharma 4.0™ and Annex 1 Conference Gallery

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International Program Committee

Annex 1 Co-Chair
Senior Consultant Aseptic Processing & Containment
SKAN AG
Past Chair
Vice President Vetter Development Service External Affairs
Vetter Pharma Fertigung GmbH & Co KG
International Board Liaison
Senior Director, Global Engineering & Technology
Johnson & Johnson
Women in Pharma Liaison and Affiliate Liaison
Vice President Strategic Development, Marketing & Communication - Partner
PQE Group
Senior Industry Advisor and Principal Consultant for Advanced Therapies
Koerber Pharma Software Inc
Emerging Leader
Network Technology Robotics Lead
F Hoffmann-La Roche AG
Emerging Leader
Process Engineer MS&T Drug Substance
Takeda