INTERPHEX Keynote Sessions on Wednesday, Oct. 20

The Pharmaceutical Technology and BioPharm International editors host industry experts in serialization and aseptic processing.

INTERPHEX will be held in person at the Javits Center, October 19–21, 2021, and—to continue a long-standing tradition—the editors of Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International have organized Keynote Sessions featuring industry experts and moderated by the editors. Unique to this year, however, the sessions will be premiered by video on the show floor. Come to the Innovation Stage to watch the following presentations.

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD

Wednesday, Oct. 20, 2021, 10:15 am–noon EDT

With the deadline for complying with the aggregation requirements of the US Drug Supply Chain Security Act (DSCSA) just two years away 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’s Nov. 27, 2023, aggregation compliance deadline and topical considerations around the European Union’s (EU) Falsified Medicines Directive (FMD). 

As the aggregation compliance for the DSCSA—delayed from 2019—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:

  • Rebecca Mullis, Engineering Project Manager, Catalent
  • Staffan Widengren, Director Corporate Projects at Recipharm
  • David Bond, Senior Manager, Thermo Fisher Scientific’s Pharma Services
  • Steve Wood, President & CEO, Covectra, Inc.
  • Alf Goebel, CEO, Advanco
  • Géraldine Lissalde-Bonnet, Director Public Policy, GS1 Global Office
  • Angela Fernandez, Vice President of Community Engagement, GS1 US.

Moderators:

Meg Rivers, Senior Editor, Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Felicity Thomas, European Editor, Pharmaceutical Technology, Pharmaceutical Technology Europe,BioPharm International.

The Evolution of Aseptic Processing

Wednesday, Oct. 20, 2021, 1:15 pm–3 pm EDT

The technical demands of aseptic processing have long challenged pharmaceutical companies and contract manufacturers to produce different volumes of safe, effective, drugs in a cost-effective manner. Drug recalls and regulatory actions have underlined the technical and regulatory hurdles. In this keynote session, experts in aseptic processing will discuss the evolution of their field, including specifics on what might be required to transform existing processing lines to comply with new regulatory requirements, the variety of challenges and new solutions available to deal with small-batch processing, and the application of single-use systems and associated issues, such as shortages and sterilization difficulties. This session will be moderated by Felicity Thomas, European Editor, Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Hear insight from consultants, academic experts, representatives from industry associations, and technical experts from companies supporting aseptic processing:

  • Richard Denk, SKAN
  • Luke Stockhausen, CRB Group
  • Patrick Nieuwenhuizen, PharmaLex
  • Rafael Beaus, Azbil Telstar
  • Jordi Serrat, Azbil Telstar.

Missed Tuesday’s Presentations?

Presentations held on Tuesday were “Equipment Trends in Advanced Solid-Dosage Drug Manufacturing” and “Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies.” Look for content from these presentations coming soon to the PharmTech.com and BioPharmInternational.com websites.