Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD – Regulatory | Part 4

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD was part of a keynote series at INTERPHEX 2021. This is part four, serialization from a regulatory perspective.

1. Watch part 1: serialization from a manufacturing perspective
2. Watch part 2: serialization from a packaging perspective
3. Watch part 3: serialization from a software perspective

About the keynote

With the aggregation considerations for the US Drug Supply Chain Security Act (DSCSA) on the horizon and uncertainties about authentication of medicines in a post-Brexit Europe, questions about compliance—and the security of the drug supply—are at the forefront.

In this discussion, global supply chain experts examine implications of the DSCSA (specifically serialization and aggregation) and topical considerations around the European Union’s (EU) Falsified Medicines Directive (FMD).

As the aggregation considerations for the DSCSA approaches, what do companies across the bio/pharmaceutical supply chain need to tackle now, and what can they expect going forward?

Within Europe, compliance with the delegated EU FMD regulation has been required since 2019. However, implementation of the delegated regulation has not been smooth sailing. In what position has Brexit left stakeholders with regards to medicines authentication? Has it been/might it be necessary to further update manufacturing and packaging lines to accommodate variances in regulations?

Experts from across the global supply chain will provide insight and answers to these questions.

About the speakers

Angela Fernandez is the vice president of community engagement at GS1 US. GS1 is a not-for-profit organization that develops and maintains global standards for business communication. Angela is responsible for driving broader adoption of GS1 Standards to help industries achieve their goals for improved traceability, information transparency, and data quality.

Géraldine Lissalde-Bonnet leads the GS1 Healthcare Global Public Policy Work Team, which has the mission to interact with decision-makers globally and to provide strategic leadership on the use of GS1 standards in the healthcare sector.

FDA spokesperson

Watch other videos in this keynote series

1. Equipment Trends in Advanced Solid-Dosage Drug Manufacturing
2. Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies
3. The Evolution of Aseptic Processing