Independent Senior Advisor Biopharmaceuticals
Former Head of Biopharma Business Unit, Boehringer Ingelheim
Hear From Top Industry Thought Leaders on the Challenges and Solutions Impacting the Pharmaceutical Industry
Why attend?
Expert Insights
Hear from industry leaders and regulators who will share their perspectives on the future of pharmaceuticals.
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.
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.
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.
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.
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
SVP Head of Product Supply Fill & Finish Expansions
Novo Nordisk A/S
Transformation Strategist and Head of Research
IAAE
Senior Vice President Head of Global Engineering and Maintenance Excellence
Bayer
GMP Inspector
AGES - Austrian Agency for Health and Food Safety
Head of Institute Surveillance
Austrian Agency for Health and Food Safety (AGES)
Your Conference Experience
Expo Hall
Expo Hall
Explore groundbreaking innovations and network with industry leaders at our dynamic expo hall.
Professional Training
Professional Training
Connect with top industry experts and expand your professional network at our exclusive networking sessions.
Live Streams
Live Streams
Experience the conference from anywhere with our interactive live stream.
Keynote Speakers
Keynote Speakers
Subject matter experts and top leaders in the pharmaceutical industry.
Conference Highlights
Pharma 4.0™ Interconnected Facility Design and Construction
The pharmaceutical industry is on the verge of a profound transformation, driven by the digital advancements of Pharma 4.0™. This shift is set to redefine the design and construction of interconnected facilities, streamlining operations and optimizing production like never before. At this year's 2024 ISPE Pharma 4.0™ and Annex Conference taking place 10 – 11 December in Rome, Italy, and virtually, industry leaders will explore cutting-edge strategies for building smart, flexible, and interconnected facilities that align with the future of manufacturing.
Pharma 4.0™ and Annex 1 – The Perfect Fit
What do the EU GMP Annex 1 and the ISPE Baseline Guide Volume 8: Pharma 4.0™ (First Edition) have to do with each other?
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.
ISPE Pharma 4.0™ and Annex 1 Conference Gallery
International Program Committee
Annex 1 Co-Chair
Senior Consultant Aseptic Processing & Containment
SKAN AG
Pharma 4.0 Co-Chair
Managing Consultant, Compliance Consulting
NNE
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
Quality and Compliance Advisor
Director, Head of Novel Modalities Market Development EMEA
Merck KGaA
Fellow - Digital Technology, Associate
CRB
Regulatory Advisor
ISPE
Managing Director
Q-FINITY Quality Management
Senior Industry Advisor and Principal Consultant for Advanced Therapies
Koerber Pharma Software Inc
Founder & CEO
LifeBee - Digitalizing Life Sciences
Vice President QA International
Cencora
Managing Director
Memo3 GmbH
Operation Technology, Digital & Data Associate Director
Merck Serono S.P.A.
Executive Industry Advisor
Körber Pharma Software GmbH
Emerging Leader
Sales Manager
VTU Engineering GmbH
Emerging Leader
Network Technology Robotics Lead
F Hoffmann-La Roche AG
Emerging Leader
Process Engineer MS&T Drug Substance
Takeda
Emerging Leader
Quality Assurance Project Manager
Lonza AG
Emerging Leader
Project Manager
Bayer AG (Supply Center Grenzach)
Emerging Leader
Project Advisor
Aseptic Mind
Emerging Leader
Managing Director
Memo3 GmbH