Welcome to the 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.
Conference Attendees
Navigate the conference platform via the listed links.
- Attendee Roster: View the full list of conference attendees - platform
- Presentation: Presentations received from speakers before the conference who have agreed to make them available are currently posted on the conference platform.
- Featured Speakers: View all session speakers
- Live-Streamed Sessions: View list of all Live-streamed sessions
Featured Sessions
Understanding Digitalization and Its Potential in Pharma 4.0
Understanding Digitalization and its Potential as a Value Driver in Pharma 4.0. In this keynote presentation, we will explore how we can drive the potential of digitalization in Pharma 4.0. A key aspect of a successful digitalization strategy is the explanation and understanding of the tools and technologies, to empower teams and individuals to drive the potential to tangible value in processes and operations.
Equipping People Who Accelerate Pharma 4.0 Transformation
During this presentation the roles of manufacturing leader and data steward will be covered, with emphasis given to examples of key knowledge, sources of information, and expected behaviours, that are considered important at several career stages for these roles.
Assessing and Ensuring Annex 1 Compliance
The new Annex 1 has been significantly expanded, however there is room for interpretation when it comes to how to be compliant with the updated version. In this presentation we will provide an 'auditors view' on how to verify/challenge if companies are compliant with the updated Annex one, illustrated by sharing experiences from recent audits.
Data Centric Architectures
In this presentation, we explore the advanced stage of Pharma 4.0 maturity and the benefits of adopting a fully data-centric architecture. The second part of the presentation addresses the requirements for implementing data-centric architectures.
Social Media
Use the hashtag #ISPEPharma40 # Annex1 and tag @ISPE in your posts highlighting your conference experience. Plus, follow the official hashtag #ISPEAnnualMeeting to stay up to date on activities and events throughout the conference and include it in your social media posts