Cortona 2018 Program Details
Cortona 2018 – An International Meeting on Advances in Pharmaceutical/Bio Innovation and Manufacturing Control
A summary of each track is included below; further details are available by clicking the links above. Each track will conclude with a panel discussion, by popular demand of IFPAC attendees.
Chair: Mel Koch
The plenary session will provide an overview on what IFPAC Cortona is intending to accomplish, an overview of the latest manufacturing innovation initiatives,a presentation from the pharma industry, from academia, the latest developments on the regulatory side, and a presentation on a very challenging and inventive project unrelated to the pharma/biotech industries. 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.
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.
Chair: Roger Nosal
This track will focus on innovative, risk-based approaches to develop and establish effective specifications and adaptive process controls that are predictive of product safety, efficacy and quality. Speakers 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. We will explore the differences manufacturers are seeing in raw materials and excipients, how they relate to product performance, and approaches for handling these differences. Sessions will also cover the relationship between pharmacopeia standards, material attributes and product quality, and how to handle equipment deviations.
Challenges and Opportunites
Chair: To be announced soon!
This track will cover the latest in innovation in continuous manufacturing, multi-disciplinary development and accelerated development, in order to address challenges found across the pharmaceutical and biopharmaceutical manufacturing industries.
Exhibition 8-10 October, 2018 - Table top displays and sponsorship opportunities are available for demonstrating products or services before a specialized audience.