Workshops

This workshop provides an integrated view of the essential processes needed for the development of safe, effective, and reliable combination products. It encompasses Design Controls, Drug Development, Risk Management, Safety Assurance, and Reliability processes, highlighting their interrelations and dependencies. By incorporating this structured approach, organizations can improve efficiencies and reduce regulatory risks while ensuring safety and effectiveness.

The growing number of potential high-volume molecules being evaluated to determine a manufacturing strategy is moving companies to investigate CBM as an alternative to batch-based platforms. Faced with making this choice between a traditional fed-batch manufacturing platform and moving to a continuous/perfusion-based process, what are the sourcing decisions that must be addressed?

In this engaging, hands-on workshop on the practical implementation of AI in GxP-regulated environments, participants will actively engage in key activities essential for successfully introducing and implementing a GMP-relevant system incorporating AI/ML components. They will explore key aspects of AI adoption in the pharmaceutical industry by applying ISPE Pharma 4.0® and GAMP® principles, including:

The ICH Q14 guideline provides a science- and risk-based approach to developing and maintaining analytical procedures, ensuring they remain fit for purpose throughout a drug’s lifecycle. However, implementing changes to analytical procedures remains complex due to regulatory variations across global markets. The adoption of ICH Q14, alongside principles from ICH Q12, offers the promise of a streamlined postapproval change management process that reduces regulatory burden while maintaining compliance.

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.

In light of the requirements discussed within the EU Guideline on computerised systems and electronic data in clinical trials and the information provided within the new GAMP Good eClinical Practice guide the workshop will explore challenges with implementing new technologies used in support of clinical trials, e.g.
1.  Decentralized Clinical Trials- Risks and concerns with the use of eClinical Platforms, e.g., ePRO, eCOA, IRT/RTSM; Roles and responsibilities for systems and validation; challenges in distribution of IMP; BYOD

Optimizing Cost of Goods for Cell Therapy Production--Current and Future Tools for Consideration This session will present two case study vignettes where companies used the Baseline Guide concepts to form the basis of design for a new manufacturing asset.  The case studies focus on key Guide principles that identify the synergies between process closure, operation efficiency, contamination risk mitigation, and facility optimization.  Specific references to the Guide will be provided as part of the interaction with the Audience.

Women in Pharma Proudly Presents the Adaptable Leadership Workshop
Join us for a transformative three-hour workshop dedicated to leadership development, team building, and personal growth, with a special focus on enhancing the audit and compliance experience, as led by Guido Kremer-van der Kamp and Yolanda McClean.

This workshop aims to bring together industry leaders and digital transformation champions to explore the latest advancements and strategies in the pharmaceutical sector. The agenda is structured into three key parts:

Part 1: Digital Transformation Champions: