Cortona 2018 Program Details
Cortona 2018 – An International Meeting on Advances in Pharmaceutical/Bio Innovation and Manufacturing Control
Chair: Mel Koch
The plenary session will provide an overview on what IFPAC Cortona is intending to accomplish, presentations from companies unrelated to the pharma/biotech industries on how they are innovating while managing regulatory requirements, a presentation from the pharma industry and a presentation from academia. This will be an engaging and diverse plenary to kickoff the conference!
Data & Information Management
Chair: Ferdinando Aspesi
The goal of this section is to discuss adding information systems that are effectively, efficiently, and securely networked across Development, Quality and Manufacturing to facilitate continuous improvement. This will include the topics of comprehensive access to product and process knowledge, systems networked, and the people skills and knowledge necessary to build and run such systems and networks.
Chair: Moheb Nasr
Topics will include an assessment of ICH progress to date, ICH Q12/Life Cycle Management and quality overall from a regulatory perspective, and will be presented by experts from industry and from the FDA. Following the presentations will be a panel discussion, by popular demand of IFPAC attendees.
Manufacturing Controls & Innovation
Chair: Ronan Farrell
This track will provide a balance of innovative ideas in both small and large molecule. Topics may include cell and gene therapy, innovations in biologics manufacturing, continuous manufacturing, mRNA manufacturing technology, and regulatory aspects of manufacturing controls and innovation.
Regulatory Challenges and Oppotunities
Chair: Sarah Pope
Topics will include the latest on innovation from a regulatory perspective and the end-to-end life cycle approach, multidisciplinary development, accelerated development and benefit-risk framework. Speakers include experts from regulatory bodies and from industry. This session will be followed by a panel discussion.
Bioanalytics & Bioassays
Chair: Roger Nosal
This track will cover multi-attribute monitoring, how bioassays and bioanalytics need to be aligned with respect to clinical relevance, and models as the basis for establishing bioassay criteria.
Chair: Roger Nosal
This section will explore the technical aspects of material controls, the differences manufacturers are seeing and how they relate to product performance.
Exhibition 8-10 October, 2018 - Table top displays and sponsorship opportunities are available for demonstrating products or services before a specialized audience.