Cortona 2021 Program Details
Our Preliminary Program is now available!
Please check back for updates!
A summary of each session is included below; further details will be available soon. Each session will include one or more panel discussions, by popular demand of IFPAC attendees.
Chair: Mel Koch
The plenary session will begin with overviews of the Pharma and Biotech industries, and the current regulatory landscape will be reviewed by both FDA and MHRA representatives. The plenary will also include exciting talks on innovations such as cell and gene therapy and personalized medicine. This will be an engaging and diverse plenary session to begin the conference!
Tomorrow's World: Big Data & Artificial Intelligence
Co-Chairs: Ursula Busse and David Churchward
This session will explore innovations in Big Data, Artificial Intelligence, and Machine Learning. Applications in large scale and personalised scale manufacturing will be covered, as well as applications in quality investigations and performance-based approaches in model validation. Moreover, opportunities, challenges and solutions concerning using AI in a GxP environment and related regulatory considerations will be discussed.
Manufacturing Innovation – Opportunities & Challenges
Co-Chairs: Roger Nosal, Ferdinando Aspesi, and Ronan Farrell
This full-day session will cover the latest in the areas of manufacturing innovation, advanced analytics and process controls, and personalized medicines. Topics include continuous manufacturing in biopharmaceuticals, process intensification, single-use technology, multi-attribute process monitoring, intensified bioprocess production, microbial controls, continuous film coating of tablets, several aspects related to cell and gene therapy, and global regulatory convergence.
Global Regulatory and Harmonization Initiatives
Co-Chairs: Larry Lee, Nick Lee and Moheb Nasr
This full-day session will have two main components. First we'll look at current ICH guidelines under development and future ICH quality strategy. Second, global CMC regulatory and pharmacopeial initiatives will be presented by experts from around the globe. Ample time for discussion will follow each section.
Wrap-Up Session & Action Planning Meeting
This session has evolved over the years to be a highlight of the Cortona conference. All attendees, speakers, and vendors will participate in break out discussions by topic of interest. This session will help participants with distilling the conference into main themes and key findings, reporting back key findings and ideas to their own organizations, and future innovation planning.
IFPAC-Cortona attendees continuously praise the benefits of attending this session and appreciate the unique opportunity it provides for transforming new ideas into next steps.
Exhibition 4-6 October, 2021 - Table top displays and sponsorship opportunities are available for demonstrating products or services before a specialized audience.