2023 ISPE Europe Annual Conference

The pharmaceutical industry has gone through radical changes in the last years across the globe. In Europe, the pandemic has underlined the importance of a unified Europe and a strong, innovative ecosystem to address the major health challenges. With advancements in technology and policy initiatives, the pharmaceutical manufacturing landscape is further transforming.

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 2023 ISPE Europe Annual Conference to learn and share progress, success stories, best practices and lessons learned.

Objectives

  • Recognise ways of working that relates to how industry work to meet current and proposed regulatory requirements
  • Learn through case studies how modern engineering and project delivery drive project managers and engineers to adapt their practices to ensure consistent continuity and successful projects
  • Follow case studies on innovation in factories of the future, continuous manufacturing concepts and production
  • Gain insight into a new world of pharmaceutical manufacturing
  • Learn how to apply a holistic view on manufacturing strategies of the future
  • Understand the operating model applied with Pharma 4.0
  • Get a feeling about readiness qualifiers for industry
  • Have dialogues with peer groups and with senior industry leaders on these hot topics

Executive Forum

The Executive Forum will address the main current issues in the pharmaceutical industry. Subject areas presented will include what the future after Covid-19 looks like, including research into new drugs based on mRNA technology and how supply chain resilience can be established in a sustainable way.

Shortages - through all stages of the value chain - materials, drugs, medical devices, and instruments is a hot topics that will be deliberated. During the forum, dialogues will focus on how digital transformation can help address these enormous problems. Additionally, the discussion will focus on what is behind the magical promise of artificial intelligence and why the value of data is currently so underestimated. We will delve into why data is considered the new gold.

You will hear from data scientists, big consultancy companies, and manufacturers on these important matters during our Executive forum sessions.


What Can You Expect?

Watch some of the 2023 ISPE Europe Annual Conference highlights to get a taste of how you'll benefit from compelling discussions and knowledge exchange opportunities on the latest advancements in pharmaceutical manufacturing facilities.

Visit the 2022 ISPE Europe Annual Page to see more recaps of this year’s conference.

Learn More


Conference Topics 

Given the impact of the evolving pandemic, an aging population, the increase in diseases with unmet needs, and an unprecedented rise in chronic diseases, the need for a constant focus on collaborative innovation and agility will shape Pharma’s priorities in the foreseeable future. ISPE will be the leader to set the pace for knowledge sharing that speaks to the current and future needs of the industry. 

  • Digital Transformation and Pharma 4.0

    The Digital Transformation Journey is one of the most important strategic challenges in today’s pharma organisations. The maturity of the Business Processes and the Pharmaceutical Quality System are prerequisites for moving into digital operations. Digital transformation is a holistic approach to move from paper to electronic workflow-based end-to-end operations along the value chain. This track will address the key challenges of the transformation which are: integration, cultural change, data availability, and strategic ownership based on practical case studies.

  • Manufacturing Trends – Annex 1, Digitalised Aseptic Production, Automated Production, Product Transfers to CMOs

    Applying harmonised approaches to innovative design solutions and project delivery strategies to ensure that quality therapeutic products are brought to market in an efficient manner to improve patient health will be the focus of this content area. Digitalised Aseptic—case studies and presentations with focus on the digital applications of aseptic requirements such as contamination control strategies and aseptic GMP requirements will be presented in this track. Fully Contained—closed systems case studies and technologies and their use in pharmaceutical manufacturing, and the role of Contract Manufacturing in repatriation of API and medicines production to Europe will be discussed and presented during the conference.

  • Good Engineering Practice

    Good Engineering Practice (GEP) is combination of standards, specifications, codes, regulatory and industrial guidelines as well as accepted engineering and design methods intended to design, construct, operate, and maintain pharmaceutical and/or biotechnology facilities that encompass regulatory compliance, safety, economics, environmental protection, and operability. This track will be inspecting the transformation of engineering and project delivery in a digitalised world through best practice cases, technical presentations, and a panel discussion on information modeling.

  • Supply Chain Resiliency

    During the conference this track will focus on the impact and potential utilisation of new technologies, processes, and disruptions on operations and logistics of the production of all types of therapies. We will be presenting content that addresses supply chain shortages; the conditions that would encourage pharmaceutical manufacturing in Europe, and the requirements for capabilities and skillsets needed for the workforce of the future.

  • GAMP 5®

    Join our speakers and validation experts for one of the most discussed topics of the year, ISPE GAMP 5® 2nd Edition. The new edition provides a substantial amount of new and updated content that the authors of the ISPE GAMP® 5 2nd Edition themselves will present. The track will provide you with in-depth insights into: Computer Software Assurance, Data Integrity, Artificial Intelligence, Agile Software Development and much more. During interactive conversations you will have the opportunity to network and engage in discussions with the GAMP 5® community on the latest trends.


Program Committee

Roderick C. Van der Graaf
Site Director
Johnson & Johnson Surgical Vision
Chair
Michael A.M. Atzor, PhD
Pharmaceutical Eng&PM Senior Expert and Consultant
Richard Denk
Senior Consultant Aseptic Processing & Containment
SKAN AG
Jean-Francois Duliere
Pharmaceutical Senior Expert, Vice Chair ISPE France Affiliate
David Estape, PhD
Technology Manager Biotechnology
CRB Group
Placeholder Person Graphic
Michael Hell
EHS Lead Global Biotech Manufacturing
Merck KGaA
Frank Henrichmann
Senior Executive Consultant
QFINITY Quality Management
Cristina Mazo
QP - Site Manager
GP Pharma
Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
Heike Roeder
Director, Lead Digital Quality, Risk Advisory Life Science
Dany SHAMI
Bayer AG
Elena Vulpe
Senior Consultant, Technology and Digital Risk
Deloitte
Amjad Wahbeh
VP Engineering Injectables Division
Hikma Farmaceutica (Portugal) S.A.
Heather D. Watson
Company Director and Consultant
TenTenTen Consulting Limited
Christian Woelbeling
Executive Industry Advisor
Körber
Thomas Zimmer, PhD
VP, European Operations
ISPE