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An IFPAC® Digital Event
Cortona Webinar Series - 2021/2022
Interactive Virtual Event
Advanced Registration Open!
While we look forward to our in-person conference in October 2022, we recognize there is new information in the world of Advanced Manufacturing Science and Regulatory Harmonization that simply cannot wait that long. IFPAC is continuing it's IFPAC Cortona Webinar Series leading up to the in-person IFPAC-Cortona 2022 event. Compelling, LIVE presentations by esteemed speakers, and a LIVE panel discussion on each topic, including questions coming directly from attendees!
November 9, 2021: Webinar I: Building Toward Future Pharmaceutical Manufacturing Through Adoption of Advanced Manufacturing Technologies
Sau (Larry) Lee et al., FDA, OPQ, Silver Spring, MD (ON DEMAND)
This webinar will discuss new advanced manufacturing platforms with respect to its importance of building a robust, flexible, and agile drug supply chain, as well as challenges and opportunities related to its adoption for commercial pharmaceutical production. This webinar is intended to provide an update on regulatory aspects of advanced manufacturing and to identify issues to be discussed in sufficient details in Cortona 2022 F2F meeting.
January 18, 2022: Webinar II: Regulatory Considerations for Innovation in Technology and Therapeutics
David Churchward, Medicines and Healthcare products Regulatory Agency (MHRA), London, UK, Ursula Busse, Boehringer-Ingelheim and Ronan Farrell, Roche Genentech
How do we ensure an enabling regulatory environment to facilitate innovation?
This webinar will use short presentations from regulator and industry experts and a moderated panel discussion to explore future opportunities to streamline the safe and rapid implementation of innovative technologies.
Examples of innovative supply chains and disruptive technologies will be used to distil the key areas of need for industry and regulators to focus future discussion, such as:
- ‘Point of care’ manufacture of personalized, short shelf life medicines
- Sterile drug product manufacturing using closed gloveless isolators for small batch production
- Manufacture and supply of short half-life radioligand therapies
Presentations and discussions will consider the importance of regulatory agility, learning from regulatory flexibility during the pandemic and how similar approaches might continue in the future.
March 15, 2022: Webinar III: Challenges Associated with Holistic Control Strategies in the Digital Age
Nick Lee, HPRA, Roger Nosal, Pfizer, and Ursula Busse, Boehringer-Ingelheim
A robust and integrated product control strategy is the centerpiece, and arguably the most important objective, in the development of a commercial product. Prospectively establishing functional relationships between input variables - e.g. process parameters and material attributes - and the CQAs of a drug product requires an enhanced understanding of the drug substance and drug product manufacturing processes as well as risks associated with concomitant variability that may impact those CQAs. Manufacturing innovation increasingly relies on automation and the application of principles described in Pharma 4.0. How to convey the generation, control and management of data, and to distinguish meaningful content for regulatory assessment in an application and for inspection, becomes increasingly important for product lifecycle management.
In this seminar you will hear from industry and regulators about the latest developments in this space. Presentations will be followed by a panel discussion intended to address questions related to the technical and regulatory challenges.
An IFPAC-Cortona meeting would not be complete without plentiful opportunities for discussion and networking, and this is no exception! Attendees will have an opportunities to interact with the speakers during a Q&A / Roundtable Discussion. Discussion boards, 1:1 messaging will also be open.
Sponsorship Opportortunities Availalble
Register for the Webinar Series Now!
Thank you to our Cortona Sponsors!
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IFPAC® - Cortona
Cortona Conference - 2022
October 2-6, 2022
Centro Convegni Sant’Agostino, Cortona, Italy
An International meeting on Pharma and Biotech Manufacturing Innovation, Advanced Analytics and Process Control, Informatics, Big Data, Knowledge Management and Global Regulatory Initiatives
For the Pharmaceutical, Biotechnology and related Manufacturing Industries
Advanced Registration Details Coming Soon!
Register for Cortona 2022 - COMING SOON
Interact with our Key Speakers from FDA, MHRA, Academia and Leading Pharmaceutical & Biotechnology Corporations
Overview
An encounter with Cortona is an encounter with art, history and spirituality. This location has been enjoyed by IFPAC-Cortona attendees since 2010 for its retreat style setting which encourages more in depth discussions between managers, executives and leaders in the industry as well as internationally recognized research institutions.
This biennial conference covers the latest in Advanced Manufacturing technology and innovation for the pharmaceutical and biotechnology industries. Involvement by government regulatory agencies provides opportunities for interaction regarding advances in Pharma and Biotech manufacturing and improved Regulatory Harmonization between the U.S. and Europe. The conference was designed for management teams within the Pharmaceutical, Biotechnology, and related industries. Numerous opportunities are provided during the conference for guests to successfully review progress in the field, hear case studies & share resources on improving manufacturing control, process optimization, and data management.
Cortona is very accessible by train from Rome, Florence, Milan, and other major cities with international airports.
Previously, the Cortona Conference took place at the same location in Cortona, Italy in September 2010, October 2012, October 2014, October 2016, and October 2018. A meeting was also held in 2008 in Siena, Italy.
In order to keep the conversation going leading up to the in-person meeting, a digital event was created in 2020. The conference consisted of a series of experts from industry, government and academia presenting the most innovative practices and strategies for implementing Advanced Manufacturing techniques while supporting global regulatory harmonization.
Organizing Committee
Ferdinando Aspesi, Bridge Associates International
Ursula Busse, PhD., MBA, Boehringer-Ingelheim
David Churchward, Medicines and Healthcare products Regulatory Agency (MHRA)
Ronan Farrell, Roche Genentech
Melvin Koch, Ph.D., CPAC, APL, University of Washington
Larry Lee, Ph. D., FDA/CDER/OPQ/OTR
Moheb Nasr, Ph.D., Nasr Pharma Regulatory Consulting (NPRC)
Roger Nosal, Ph.D., Pfizer
Robert Zutkis, IFPAC