Cortona 2020 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. Possible topics include continuous manufacturing in biopharmaceuticals, process intensification, single-use technology, multi-attribute monitoring, intensified bioprocess monitoring, several aspects related to cell and gene therapy, self-adaptive process controls, 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
Numerous opportunities are provided during the conference for pharmaceutical thought leaders to discuss and evaluate progress made to date and to propose new ways to introduce innovation and improve manufacturing control and process optimization. Participation of key regulators is fundamental to achieve successful outcome. In this session we plan to assess Cortona 2020 progress and seek feedback from participants, vendors and speakers. Future Cortona meeting planning will be based on the outcome of this session. It is also likely to publish a white paper summarizing Cortona 2020 presentations, posters and wrap-up session key findings.
All meeting attendees are invited to join the organizing committee to participate in the wrap-up session.
Exhibition 5-7 October, 2020 - Table top displays and sponsorship opportunities are available for demonstrating products or services before a specialized audience.