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2022 ISPE Annual Meeting & Expo

SES213 - Concurrent Session: Regulatory Considerations to Boost


Nov 1, 2022 4:00pm ‐ Nov 1, 2022 5:30pm


Description

The pace of innovation in the pharmaceutical field is accelerating and the development of a global, flexible and harmonized regulatory framework will be a key enabler to bring medicines to patients faster. Since its inception, ICH has been concerned with establishing global convergence and alignment on technical criteria with the intent to harmonize regulatory expectations. This session is intended to provide a status update of regulatory changes that will boost innovation. The presentations will set the stage of the current barriers to harmonization and to implementation of innovative technologies such as API continuous manufacturing and will offer a proposal for a more comprehensive QOS document that provides a mechanism for industry to convey a holistic view of their control strategy. The session will highlight examples of how to overcome technical and regulatory challenges and enable supply chain resilience.

Speaker(s):

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