Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD – Manufacturing | Part 1

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 one of four, serialization from a manufacturing perspective.

1. Watch part 2: serialization from a packaging perspective
2. Watch part 3: serialization from a software perspective
3. Watch part 4: serialization from a regulatory 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

David Bond is a senior manager (packaging engineering) and serialization program lead with Thermo Fisher Scientific’s Pharma Services, a contract development and manufacturing organization. David has 25 years of experience in the pharma industry, including manufacturing, validation, packaging, engineering, and serialization.

Rebecca Mullis is an engineering project manager for Catalent Biologics, a contract development and manufacturing organization. Rebecca has more than 13 years of experience in the pharmaceutical industry and project management. Rebecca is responsible for managing the design, implementation, and qualification of large capital projects within the biologics business.

Staffan Widengren is the director of corporate projects at Recipharm, a contract development and manufacturing organization. Staffan has between June 2015 and April 2019 acted as program manager for the Recipharm global serialization project and part of a global steering committee that is working closely with Recipharm’s clients to ensure they plan and implement changes that comply with pending regulatory requirements for drug serialization.

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