Cortona 2016 – An International Meeting on Advances in Pharmaceutical/Bio Innovation and Manufacturing Control
3 October, 2016
Monday AM - Plenary
Pharmaceutical/Bio Manufacturing Innovation
Chair: Mel Koch
This conference provides key industry, regulatory and academic thought leaders the opportunity to share experiences and relevant examples, discuss important scientific and regulatory challenges, and propose meaningful strategies to progress innovative manufacturing.
The Cortona 2016 conference can benefit from the learnings of non-pharma industrial sectors and how they were able to address business, technological and regulatory challenges.
Monday PM - PAT - Process Controls- Data Analytics and Continuous Improvement
Chair: Ferdinando Aspesi
The scope of this section is to provide an overview of PAT applications and their lifecycle management, Process Controls and Data Analytics to support Technology Innovations, Continuous Improvement for Marketed Products in a regulated environment and discuss related Challenges.
4 October, 2016
Tuesday AM and PM - Manufacturing Innovation
Chair: Moheb Nasr
Similar to other manufacturing sectors, there is a desire to introduce innovative approaches to pharmaceutical manufacturing. Manufacturing innovation in the pharma sector could lead to more robust processes, real time quality control and simplified supply chain. Continuous manufacturing is gaining momentum in industry and is supported by major regulators. This session will build on Cortona 2014 Continuous Manufacturing discussion. Presentations describing approaches used outside pharma industry and detailed case studies describing different implementation strategies will be presented by industry technical leaders. Regulators from FDA and EU will share their perspectives on relevant regulatory and GMP issues.
Presentations will be followed by panel discussion.
5 October, 2016
Wednesday AM - Global Regulatory Harmonization
Chairs: Sarah Pope Miksinski and Roger Nosal
The scope of this section focuses on opportunities to improve global regulatory harmonization. This session will highlight industry experience in extending implementation of ICH–Q guidelines and principles beyond ICH regions and introduce innovative, Quality by Design inspired approaches to improve global convergence and address the growing emphasis on regulatory acceleration. In addition, this session will articulate the challenges and costs of global regulatory divergence.
Wednesday PM - Global Manufacturing Innovation
Session Chairs: Brian Carlin, FMC, Corp. , Lawrenceville, NJ, USA and Mel Koch, CPAC, APL, University of Washington, Seattle, WA, USA
6 October, 2016
Thursday AM - Wrap-Up Session/Action Plan Meeting - All
This section will be a roundtable discussion on the actions and outcomes of the meeting, with the goal of developing a roadmap of implementation.
Exhibition 3-5 October, 2016 - Table top displays and sponsorship opportunities are available for demonstrating products or services before a specialized audience.