2024 ISPE Europe Annual Conference: Overview of Tracks from the Conference and Iberia Affiliate Chair

This year’s conference will take place in Lisbon, Portugal, 16-18 April. It will be a great opportunity to share some of the most interesting projects taking place in Europe not only through different presentations but also through facility tours and workshops.

The conference is structured with plenary sessions and five specific tracks that will focus on Digital Transformation, GAMP®, Good Engineering Practice and Efficient Investment Management, Learnings from GXP Inspections to Prepare for the Future, and Regulatory Trends and Drug Availability.

General sessions will take place throughout the day on Tuesday, 16 April, with:

• Remarks from the Executive Chair, Udo Vetter, Vetter Pharma International GmbH
• A spotlight on 2024 Facility of the Year Award (FOYA) Category Winners featuring European project honorees with a focus on engineering and project delivery
• A regulatory keynote address with Rick Friedman, with the US Food and Drug Administration (US FDA)/CDER, followed by a regulatory panel discussion later in the day
• “Operations Excellence Meets Digital” with Michelangelo Canzoneri, Merck KGaA Darmstadt, Germany, and Daniele Iacovelli, F. Hoffmann-LaRoche

Highlights from the conference’s five tracks are as follows:

Digital Transformation: Use Cases, Key Benefits, and Lessons

Learn about recent projects in digital transformation and Pharma 4.0™ and how innovators in the industry are leveraging new technologies to transform business processes and ensure long-term growth. Presenters will share in-depth use cases on GxP Cloud, artificial intelligence (AI), big data analytics, and more.

GAMP

New approaches in GAMP and Validation 4.0 are reshaping traditional ways of working. This track will feature a variety of sessions including the latest developments in computer system validation, the impact of the ISPE GAMP 5 Second Edition on the pharmaceutical industry, the FDA's stance on Computer Software Assurance (CSA), and organizational adaptation to CSA environments. Discussions will cover progress, challenges, and implications of FDA Draft Guidance on CSA for 21 CFR Part 11, along with updates on AI/ML applications in computer systems.

Good Engineering Practice and Efficient Investment Management

Sessions in this track will include Close Processing at Risk, Project Governance – Key for Project Success, Impact Analysis on Project Risks on Investment, Case Study: Experience with Risk Management for Large CAPEX Projects, and ISPE Baseline Guide Volume 6: Biopharmaceutical Manufacturing Facilities (Third Edition.)

In the latter session, attendees will have the opportunity to gain the latest insights on the use of Quality Risk Management (QRM) and Contamination Control Strategy (CCS) when designing biopharmaceutical facilities to protect products and ultimately, patients, with an overview of the ISPE Baseline® Guide Volume 6: Biopharmaceutical Manufacturing Facilities (Third Edition).

Learnings from GXP Inspections to Prepare for the Future

Innovations in treatment modalities and technology are shaping new audit and regulatory inspection models. Presenters for this track will share real-world examples across the product development lifecycle, providing insights on key trends in regulatory findings and strategies for pre-inspection regulatory engagement.

Regulatory Trends and Drug Availability

Must-see sessions will cover advances in gene editing, where the industry is with PFAS and Titanium Dioxide, a state-of-the-industry overview on drug shortages prevention, and a panel discussion on drug shortages.

With the program completed the conference will be very much focused on case studies where participants will be able ask for details to the panels of experts and take key takeaways on other industry member experiences through all the five tracks. The conference’s aim is to influence the industry through thought-provoking sessions that will speed up projects and lead the industry toward the next level of excellence.

Reap the Benefits of Connecting with Peers and Learning from Experts

The conference provides an excellent opportunity to share experiences, as well as discuss interpretations, challenges, and possible solutions for compliant implementation of new regulations. Attendees are encouraged to ask questions during panel discussions and interact with presenters and peers following these discussions.

The pharmaceutical industry is diverse, ranging from ATMPs to generics, and the challenges and priorities of each company can differ. However, in all cases, staying on track of trends tackled at the conference will be key for the industry. These trends are necessary to ensure long-term sustainability – not only from a business perspective but also in terms of compliance.

With a vibrant exhibitor area, plenty of networking breaks, and social events, the conference is going to be a great occasion to get together, share learnings and achievements, and look forward to future opportunities for the industry.

Looking forward to the event in Lisbon, Portugal, very soon, 16-18 April!

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