2023 ISPE Pharma 4.0™ and Annex 1 Conference

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Overview

The 2023 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.

Throughout this event, we'll be delving into key areas, exploring:

Technical Presentation

Pharma 4.0™ Integration

Discover how Pharma 4.0™ principles and digitalization transform operations, quality, and maintenance within the pharmaceutical landscape.

Technical Presentation

Annex 1 Implementation

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

Case Studies

Automation

Dive into the impact of automation on cutting-edge processes like ATMPs and gene therapy, redefining how we work.

Case Studies

Rapid Monitoring and Testing

Uncover how rapid microbial monitoring enhances quality control precision and streamlines supply chains.

Case Studies

Expert Insights

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


Keynote Speakers

Maria Jesus Lamas Diaz
Director
AEMPS (Spanish Agency of Medicines and Healthcare Products)
Evdokia Korakianiti
Head of Quality and Safety of Medicines
EMA
Christoph Prinz
Vice President Global Operational Quality
BioNTech
Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
Christian Wölbeling
Executive Industry Advisor
Körber Pharma Software GmbH

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Featured Topics 


Why Attend the 2023 ISPE Pharma 4.0™ and Annex 1 Conference?


Conference Highlights


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Company Type

Programme Committee

Cristina Mazo
QP - Site Manager
GP Pharma
Chair - Pharma 4.0
Jörg Zimmermann
Vice President Vetter Development Service External Affairs
Vetter Pharma Fertigung GmbH & Co KG
Chair - Annex 1
Nuha Al-Hafez
Quality Fundamentals Area Lead
Roche
Maria Amaya
Lead External Advocacy North America (Quality Policy)
Genentech, A Member of the Roche Group
Emerging Leader
Richard Denk
Senior Consultant Aseptic Processing & Containment
SKAN AG
Yvonne Duckworth, PE
Fellow - Digital Technology, Associate
CRB
Jean Francois Duliere
Reg Advisor
ISPE
Matthew P. Gorton
Director of Business Development
GBA Life Sciences
Felix Kern
Associate Director - Head of Compliance Launch and Technology Center
Merck KGaA
Violeta Mihailova
Sr. QA Specialist
Bristol Myers Squibb
Emerging Leader
Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
Placeholder Person Graphic
Isabel Garcia Mora
Quality Assurance Project Manager
Lonza AG
Emerging Leader
Line Lundsberg-Nielsen, PhD
Managing Consultant, Compliance Consulting
NNE
Heike Roeder
Vice President QA International
Cencora
Placeholder Person Graphic
Pol Bonet Sune
Project Advisor
Aseptic Mind
Emerging Leader
Alicia Tébar
Founder. QbD & GMP Consultant
QbD Pharmaceutical Services SL
Placeholder Person Graphic
Sofie Strejby Thomsen
Junior Consultant, Facility Operations
NNE
Emerging Leader
Josef Trapl
Managing Director
Memo3 GmbH
Stephen Wing
Head of Analytical & Logistical Services
Merck KGaA
Wolfgang Winter
Software Framework R&D Director
Agilent Technologies Deutschland GmbH
Christian Wölbeling
Executive Industry Advisor
Körber Pharma Software GmbH

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