Open to all Attendees. No Extra Fee

Blockchain applications in pharma and biopharma are becoming more mainstream; for the past 4 years we have held a blockchain session at the annual meeting where we seek to educate and inform our members about the most significant applications of the technology. In this session we will hear from three speakers, each covering a component of industry trends - pragmatic use case of how blockchain is improving operations; industry consortia and foundations, guidance on utilizing blockchain in regulated environments. These different points of view will combine to help the audience understand what is actually happening with the technology and will prepare listeners as their organizations continue (or begin) to leverage decentralized ledger technology.

Continuous manufacturing has been the dominant OSD industry buzz for years, yet its acceptance into the manufacturing business has been less than expected. This session will provide the attendee with insights based on financial modelling and case studies. This session will begin with a business model comparing CM with traditional batch manufacturing. Then two case studies will be presented which will provide the advantages, disadvantages, and benefits of each program, major challenges, and lessons learned. 

This session will provide the attendee with valuable information regarding its justification, major challenges, benefits, and lessons learned when evaluating and considering the use of continuous manufacturing.

ICH Q12 is a truly transformational guideline that has a wide scope of applicability across the pharmaceutical development lifecycle and can help streamline the post-approval change management process by promoting the adoption of flexible science- and risk-based approaches. While in some markets full ICH Q12 implementation is well underway, in other markets ICH Q12 adoption has been partial or lagging. Further, potential lack of global convergence and alignment on ICH Q12 implementation approaches creates a risk of divergent implementation strategies among health authorities, placing an additional burden on the applicants and making the overall process less efficient. This session will summarize progress made to date on the global implementation of ICH Q12 and reflect on the remaining challenges and future opportunities to accelerate its adoption across the different regions. Featuring both industry and regulatory presenters, the session will help foster the open industry-regulator dialogue on the path forward to the global ICH Q12 adoption and help draw attention to the remaining implementation challenges and roadblocks.

In the ever changing landscape of the biopharmaceutical industry, new technologies are being created to evaluate the effectiveness of company procedures and overall performance. During this session, we will hear from leaders in the industry about how developmental technology have helped improved financial analysis to support decision making, the digitization of workflow in cleanrooms, pharma 4.0 implementation, and digital control systems used for manufacturing/traceability of gene-based medicines.

Data really is the new oil, but how can we effectively rely on digital transformation as a business advantage? Applying efficient analytics methods unleash a complex amount of opportunities in root cause analysis and accelerate the decision-making processes within an organization to help us navigate better solutions. But as data relevance increase, regulations do too.

Understanding new requirements in data trends and best practices in quality and security will help you thrive in process control and patients' safety. 

This session will disclose critical elements in Digital Transformation to accelerate the adoption of new analytical models and data collection strategies for the betterment of our processes and quality control, while keeping compliance with the latest regulatory requirements on data trending. 

The speakers will also discuss actual case studies and encourage discussions around new modelling approaches to systems predictions and applications within the manufacturing process.