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Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.
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 three of four, serialization from a software and data management perspective.
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.
Alf Goebel is the CEO of advanco, provider for Level 3 and Level 4 Item Level Serialization. Alf has more than 25 years of enterprise software industry experience. He has strong operational experience, specializing in high-growth businesses in Europe and the United States.
Steve Wood is the president and CEO of Covectra, a leader in track and trace solutions. Steve has more than 30 years of experience in international business development and program management.