2024 ISPE Europe Annual Conference

Please Note:

  • All full-access registration (virtual & in-person) includes access to speaker presentations, on-demand content, and other conference material.
  • NOTE: Material is only available from those speakers/companies that permitted distribution.
  • Registrants will receive email notification when the on-demand content is available.
  • On-demand content is accessible for 90 days.

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Conference Overview

This European Annual Conference draws pharmaceutical and biopharmaceutical professionals at all levels of the industry - from students and emerging leaders to the most senior executives in drug manufacturing, supply chain, devices, equipment and services, and global regulatory agencies. We welcome you to participate at the 2024 ISPE Europe Annual Conference to learn and share progress, success stories, best practices and lessons learned.

Regulatory Presence at the 2024 ISPE Europe Annual Conference:

Australian Government Department of Health
Danish Medicines Agency
EMA
FDA
Infarmed
MHRA
PIC-S
SwissMedic

Featured Session Speakers

Rick Friedman
Deputy Director, Office of Manufacturing Quality
FDA/CDER
Andrea J. Goddard
Head of Quality & Compliance
F. Hoffmann-La Roche Ltd
Timo Kistner
EMEA Industry Lead for Manufacturing and Industrial
NVIDIA
Evdokia Korakianiti
Head of Quality and Safety of Medicines
EMA
Sumit Verma
Senior Vice President, Commercial Manufacturing
Iovance Biotherapeutics, Inc.
Thomas Wozniewski, PhD
Global Manufacturing and Supply Officer
Takeda Pharmaceuticals International AG


Key Conference Takeaways

Keynotes

  • Progress and commercialization of new therapy concepts; example of autologous cell therapies
  • EMA's and FDA's view on the industry's preparedness, performance, and challenges for integrating innovation - QRM is in the center! 
  • Business roadmap
    • How top manufacturing companies organize the digital transformation: chances, opportunities, benefits, risks and obstacles
    • When reality meets theory in Pharma 4.0 environment.
  • Metaverse, a parallel universe of data: how and when can it help the pharmaceutical industry?

Regulatory Panels

  • Regulatory Panel 1 with FDA, EMA, WHO and INFARMED
    • This panel will focus on harmonization to break down barriers to robust supply chains. What can industry and regulators deliver in a collaborative approach.
  • Regulatory Panel 2 with EMA and Danish Medicines Agency on regulatory preparedness for Digital Transformation.
    • A dialogue between regulators and senior industry leaders.
    • Where is the pharmaceutical industry today on the digital transformational journey from an industry perspective?
    • What about the master data management framework and governance structure? 
    • QRM-based approach in the light of updated ICH Q9:  e.g. formality, subjectivity, risk-based decision making, product availability?

Case Studies

  • Digital Transformation: Use Cases, Key Benefits, and Lessons Learned
  • Learnings from GXP Inspections to Prepare for the Future
  • Regulatory Restrictions and Drug Availability
  • Good Engineering Practice and Efficient Investment Management
  • GAMP® 5, FDA CSA, cloud computing SAAS, eBatch records with Pharma 4.0

Conference Topics

The 2024 Europe Annual Conference Programme Committee is requesting proposals aligning with the following content areas:

Why Attend the 2024 ISPE Europe Annual Conference?



Conference Highlights


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International Programme Committee

Udo J. Vetter
Head of the Advisory Board
Vetter Pharma International GmbH
Executive Chair
Cristina Mazó
Site Manager
GP Pharm
Conference Chair
Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
International Board Liaison/Foundation Board Liaison
Thomas Carganico
Vice President Strategic Development, Marketing & Communication - Partner
PQE Group
Women in Pharma® Liaison
Michael A.M. Atzor, PhD
Senior Consultant&Expert Pharmaceutical Eng&PM
ISPE D/A/CH
Mark Birse
Vice President Technical
Parexel
David Churchward
Head of Operations Quality, Compliance and External Affairs
AstraZeneca
Richard Denk
Senior Consultant Aseptic Processing & Containment
SKAN AG
Yvonne Duckworth, PE
Fellow - Digital Technology, Associate
CRB
Jean-François Duliere
Regulatory Advisor
ISPE
David Estapé, PhD
Technology Manager Biotechnology
CRB Group GmbH
Frank Henrichmann
Senior Executive Consultant
QFINITY
Oliver Herrmann
Managing Director
Q-FINITY Quality Management
Shikha Raikundalia
CSV Consultant
Integrity
Alice Redmond, PhD
Chief Strategy Officer
CAI
Søren Thuesen Pedersen
Senior Director, External Affairs, Regulatory Policy and Intelligence
Novo Nordisk
Heather D. Watson
Director
TenTenTen Consulting Ltd
Christian Wölbeling
Executive Industry Advisor
Körber Pharma Software GmbH
Placeholder Person Graphic
Navneet Dhesi
Process Engineer
IPS
Emerging Leader
Placeholder Person Graphic
Michael Hell, PhD
Head of Environment & Sustainability Healthcare Operations
Merck KGaA
Emerging Leader
Laura Kuger
PhD Candidate
Karlsruhe Institute of Technology (KIT)
Emerging Leader
Violeta Mihailova
Sr. Specialist QA Operations
Bristol Myers Squibb
Emerging Leader

Conference Sponsors

Aqua-chem

Arcadis

Ellab

Fluor

Lowenco

MAASI

Novo Nordisk

Roche

Tulip

Wood