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 introduction to the IFPAC Cortona conference and an overview of what it intends to accomplish. There will be presentations on innovations in the pharma industry and from government regulatory agencies (FDA and EMA). This provides opportunities for interaction on topics of advances in technology and improved Regulatory Harmonization between the U.S. and Europe. Advances in Cell and Gene Therapy and a description of Pharma 4.0, along with a presentation on innovations in academia will be included in the plenaries. This will be an engaging and diverse plenary session to begin the conference!
IT & 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 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.
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.
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 Corona 2018 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 2018 presentations, posters and wrap-up session key findings.
All meeting attendees are invited to join the organizing committee to participate in the wrap up sessions.
Exhibition 8-10 October, 2018 - Table top displays and sponsorship opportunities are available for demonstrating products or services before a specialized audience.