Maintaining the principles and framework of the first edition, ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) updates their application in the modern world including the increased importance of service providers, evolving approaches to software development, expanded use of software tools and automation, and modern approaches to managing infrastructure.

The session highlights the use of critical thinking by knowledgeable and experienced SMEs to define appropriate approaches.

Presentations delivered in this session will provide a foundation for the "**New GAMP 5** 2nd Edition roundtable" session which follows on after this session and will allow for a deeper dive into the detail of the Second Edition.

The use of Hydrogen Peroxide (H2O2) for decontamination of equipment and/or medical devices has traditionally relied on initial validation and periodic revalidation to check the efficacy of the process with biological indicators (BIs). Enzyme Indicators (EIs) are an innovative rapid tool for providing instant and quantitative feedback, of H2O2 efficacy by providing real time quantifiable data when applied to cycle optimization, qualification, continuous process monitoring and trouble-shooting.

This session will provide an overview of the technology and how it can be used throughout the validation phases whilst showcasing data from various pharmaceutical companies and their collective suggestions on applications and future usage of EIs. Presentations will demonstrate the EIs ability to aid, clarify and provide additional confidence of H2O2 cycles and also share details of how a working group has been established to provide a consistent approach to industry application of H2O2 decontamination including the use of EIs.

This session aims to provide a diverse set of perspectives on quality/regulatory topics as it pertains to late stage/commercial ATMPs (primarily autologous cell therapy). The goal is to bring industry and regulators together to discuss shared challenges and highlight learning opportunities for both as this field evolves. In particular, the presenters will provide a good view of what areas of opportunity exist - focus areas on capacity expansions/needs, aseptic processing challenges, raw material challenges, and inspection aspects are examples of the topics that would be mutually beneficial as well as of great interest to attendees. While technical challenges are at the forefront of this complex manufacturing environment, the regulatory and quality considerations associated with these need to be factored in so that health authority expectations can continue to be met. Further industry-regulator collaboration will aid in this effort.

As we enter a transitional period within the pandemic, some uncertainties remain. The need to continually improve supply chain resiliency remains certain, as demonstrated by the challenges with Single Use Systems. Health Authorities (HA) globally demonstrate continued interest in adopting measures targeted towards drug shortage prevention activities, particularly in regard to risk assessment and business continuity planning. In parallel over this past year, the ISPE Drug Shortages Initiative has modernized the drug shortages prevention plan and prepared an example of how to apply risk management concepts to drug availability. Experts from the front line will present experiences.

As a result of this session participants will gain:

• Experience and learnings from the COVID 19 pandemic supply chain pressures particularly as applicable to Single Use Systems (SUS).
• Learnings relevant to Single Use Systems shortages and strains in the supply chain during and after the COVID 19 pandemic.
• An overview of initiatives which aim to achieve further transparency across the supply chain.
• Example approach of Quality Risk Management to address Product Availability Risks, as discussed in the draft ICH Q9(R1).
• An understanding of HA perspectives (e.g., FDA, ANVISA, ANSM, etc.)
  
  Opportunities to interact with FDA and industry in a Q&A session and informally at the conference.

Growing expectations for state-of-the-art innovation in the combination product space continue to evolve around the world. Shifts in regulatory frameworks, guidance, control strategies and technical product solutions are making substantive impacts on the delivery of new medicinal therapies. Yet, efforts to drive convergence are in their infancy. 

This session will discuss a range of key shifts in the expectations, practices and state-of-the-art technology solutions, including the QSR Amendment proposed rule, the Genus v. FDA court decision, Essential Performance Requirements, Combination Products Human Factors and Risk Management, EU MDR, and Harmonization Efforts underway. 

Case studies will be presented, reflecting the impacts of these evolving expectations on combination products.