Digital Transformation - Practical Implementation of New Tecnologies

Apr 15, 2024 1:00pm ‐ Apr 15, 2024 4:00pm

Identification: EU24CEAPR1/SESWS1

Digital Transformation - Practical Implementation of New Technologies |

Case studies: GxP Implementation of:

  • PAT (Process Analytical Technology) in continuous manufacturing
  • AR/VR (Augmented Reality/ Virtual Reality) and other technologies to Digitalise the learning journey

Organizations seeking to keep up with the digital transformation are investing in new technologies with an end-to-end (E2E) focus on their products and processes, aiming to improve operational excellence, worker experience, product quality and delivery timelines. Adoption of these new technologies requires a systematic, structural, and holistic transformation of individuals and the organization. Smart organizations of today and the future need to effectively capture, maintain and share their data, information and knowledge - including their people’s implicit and tacit knowledge - to maintain a competitive advantage and meet these high demands.

During this workshop, participants will explore multiple ISPE industry guidance (e.g. Pharma 4.0, PAT, GAMP, Knowledge Management, APQ guides) in an interactive discussion session and hear from industry experts with extensive experience in digital project/program implementation. Participants will engage in one of two case studies and learn how guidance can be applied for successful implementation of these new technologies, with a focus on people change management and best practices for sustaining the business process while navigating the digital transformation and technology adoption.

  • Collective group discussion with an overview of industry guidance to set the stage for technology implementation.
  • Participants will be divided into two groups to work on one of two case studies: PAT (Process Analytical Technology) application in continuous manufacturing or AR/VR Augmented Reality and Virtual Reality for upskilling and training
  • Both groups will work on developing a case study specific plan based on industry guidance and experience of the workshop leaders and participants.
  • Participants will identify good practices and pitfalls in project approval, implementation and sustainability.
  • Each group will report back and share their experiences in the collective group discussion.
  • The output of the workshop will be utilized and presented on the ISPE blog and/or the Pharmaceutical Engineering magazine.

Validation of SaaS Cloud Platforms for Pharma Industry

Apr 15, 2024 1:00pm ‐ Apr 15, 2024 4:00pm

Identification: EU24CEAPR1/SESWS2

Validation of SaaS Cloud Platforms for Pharma Industry: Balancing Innovation with Data Integrity in a GxP and non-GxP landscape

Pharmaceutical industries are rapidly adopting Cloud Software-as-a-Service (SaaS) platforms to streamline process, enhance collaboration and empower clinical trials. This presents both opportunities and challenges. While SaaS offers scalability, cost-effectiveness, improved collaboration (allowing remote work), ensuring data integrity is paramount. This workshop will explore the latest trends in SaaS validation for GxP (GMP, GLP, GCP) and non-GxP applications, highlighting key data integrity challenges. We will discuss evolving regulatory landscape, emphasizing the importance of adhering to regulations like 21CFR Part 11 and EU Annex 11 for electronic records and signatures and guidelines such as GAMP5 2nd edition. The workshop concludes by presenting key challenges when validating a Cloud Saas platform which will be discussed in a roundtable format in groups, boiling down towards a roadmap to best navigate these challenges and achieving a successful validation in this dynamic field.

Key challenges:
1. Shared Responsibility Model: Balancing the responsibilities of data security and integrity between pharmaceutical companies and cloud SaaS providers
2. Vendor Lock-In: Mitigating the risk of being locked to a single SaaS provider, potentially hindering future data transferability.
3. Data Residency and Control: Ensuring compliance with regional and global data privacy regulations, such as GDPR, and maintaining control over where sensitive clinical trial data is stored.
4. Audit Trail Comprehensiveness: Guaranteeing a comprehensive and auditable record of all data activity within the SaaS platform, including user actions and system changes.
5. Integration with existing systems and scalability for emerging technologies: Assessment of integration with current technologies and emerging technologies (for enhanced data security and traceability), while validation procedures remain robust.

Welcome to the ISPE Europe Annual Conference

Apr 16, 2024 9:00am ‐ Apr 16, 2024 9:20am

Identification: EU24CEAPR1/SESP1

Welcome Message from President and CEO of ISPE

Remarks from the Executive Chair

Apr 16, 2024 9:20am ‐ Apr 16, 2024 9:30am

Identification: EU24CEAPR1/SESP8

Commercializing Autologous Cell Therapies

Apr 16, 2024 9:30am ‐ Apr 16, 2024 10:00am

Identification: EU24CEAPR1/SESP3

The US FDA recently granted accelerated approval for Iovance Biotherapeutics’ AMTAGVI™ as the first and only one-time, individualized T cell therapy treatment for Metastatic Melanoma opening the doors for many future state advanced therapies in solid tumor treatment.  This keynote presentation discusses the overall journey of how the world’s 1st solid tumor cell therapy went from bench scale research at Dr. Steven Rosenberg’s laboratories to being a FDA approved commercial therapy.  With 2,000+ cell and gene therapies in clinical trials worldwide, regulators including US Food and Drug Administration, Health Canada and European-Medicines Association, will determine whether these innovative therapies move from the laboratory to the market. The session will provide the audience an exclusive look at the overall cell therapy market landscape, key learnings from unique CMC matters to scaling-up personalized therapies and to what regulators are expecting from late-stage oncology companies to receive expedited approvals.  Lessons learned from both CAR-T and TIL launches will be discussed to shed light on what others can do to enhance their opportunities to accelerate both the development and approval of advanced therapies for the treatment of cancer and rare diseases.

The Magic of Mushrooms

Apr 16, 2024 10:00am ‐ Apr 16, 2024 10:30am

Identification: EU24CEAPR1/SESP4

The Magic of Mushrooms: How Learning from Fungi Ecosystems can Help Us Design the Function and Features of Our Future

Andrea “Andi” Goddard, Head of Global Pharmaceutical Technical Operations Quality & Compliance at Roche, explores one of the greatest challenges to the future of pharmaceutical manufacturing  – designing, sustaining, evolving and navigating the increasingly complex industry and organizational networks necessary to deliver for patients.   Andi hypothesizes that the natural world, which has been building, shaping, and evolving complex networks of its own for millions of years, may provide our industry with  inspiration and insights.  Examining the world of subterranean fungal networks, Andi looks at how they connect living organisms, facilitate the complex exchange of signals, information and resources and help sustain entire ecosystems - and considers what we can learn as we build and create the future of manufacturing.

Welcome from the ISPE Vice President of European Operations

Apr 16, 2024 10:30am ‐ Apr 16, 2024 10:40am

Identification: EU24CEAPR1/SESP16

Strengthening Value Chain Resilience

Apr 16, 2024 11:30am ‐ Apr 16, 2024 12:00pm

Identification: EU24CEAPR1/SESP15

Takeda's focus on resilience in the face of supply chain disruptions is crucial for ensuring the continuous supply of life-transforming treatments to patients. To achieve this, Takeda's global manufacturing and supply (GMS) division has been actively working on transforming its operations to build a more resilient, efficient, and sustainable value chain. Key elements include the simplification and harmonization of business resilience and end-to-end supply chain processes, stronger collaboration with internal and external interfaces and stakeholders and a more dynamic and proactive data-driven risk mitigation based on innovative data, digital and technology.

FDA Regulatory Keynote

Apr 16, 2024 2:00pm ‐ Apr 16, 2024 2:30pm

Identification: EU24CEAPR1/SESP7

2024 Facility of the Year Award (FOYA) Category Winners

Apr 16, 2024 12:00pm ‐ Apr 16, 2024 12:30pm

Identification: EU24CEAPR1/SESP11

ISPE’s Facility of the Year Awards (FOYA)  is an annual program that recognizes state-of-the-art projects utilizing new, innovative technologies  to improve the quality of products, to reduce the  cost of producing high-quality medicines, and demonstrate advances in project delivery. For nearly  20 years, FOYA has been recognizing innovations in the pharmaceutical industry.  Join us as we announce the 2024 ISPE FOYA Category Winners for their exemplary projects.