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.

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.

Requested Submission 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. 

The 2023 Europe Annual Conference Programme Committee is requesting proposals aligning with the following content areas:

  • 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. The ISPE Pharma 4.0 strategic program supports this by working on technical articles, collection of practical case studies, and a new Baseline Guide to help the industry to undergo this transformation. The digital transformation is a holistic approach to move from paper to electronic workflow-based end-to-end operations along the value chain. The Focus Area will address the key challenges of the transformation which are: Integration, cultural change, data availability, and strategic ownership based on practical case studies.

  • 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 sessions 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 and the latest trends.

  • 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 focus area 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.

  • Manufacturing Trends

    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. Submissions addressing these topics are particularly welcomed: Digitalised Aseptic—case studies and presentations focusing on the digital applications of aseptic requirements such as contamination control strategies, aseptic GMP requirements, etc.; 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.

  • Supply Chain Resiliency

    The impact and potential utilisation of new technologies, processes, and disruptions on operations and logistics of the production of all types of therapies. We’re looking for submissions that address 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.

Call for Proposals Timeline

  • Submission Deadline - Closed
  • Committee Review Begins
  • Submitters Notified of Committee Decision

Program Committee

Roderick C. Van der Graaf
Site Director
Johnson & Johnson Surgical Vision
Richard Denk
Senior Consultant Aseptic Processing & Containment
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
Bayer AG
Elena Vulpe
Senior Consultant, Technology and Digital Risk
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
Thomas Zimmer, PhD
VP, European Operations