Webinar on June 20 @ 12-1p ET

Navigating Serialization Compliance to Meet November’s FDA Enforcement Deadline

Join us for a webinar with experts on navigating serialization compliance and beyond. Discussion will range from the most critical aspects of the new requirements to best practices for dealing with requests and exceptions. You will also gain insight on efficiently and effectively managing serialization programs that you can apply in your own organization.

Since the DSCSA entered its enforcement phase last year, license holders of drugs marketed in the U.S. are now working to:

  • Successfully send compliant data to trading partners for unit level traceability
  • Develop and manage process for data exceptions
  • Review and address tracing and verification requests
  • Support traceability systems and quality processes long-term

Because wholesalers and dispensers (including specialty pharmacies) are now facing serialization requirements for the very first time, they are also responding by pushing demands back onto the manufacturers.

Navigating serialization compliance to ensure treatments reach patients successfully.

On top of that, there are manufacturers still struggling with ongoing situational assessment and solution selection.

Whether you have an active serialization program for your commercial product portfolio already or are in the process of standing up your program for the first time, this event will help ensure you have the adequate set-up, as well as best practices and procedures to avoid the ramifications of missing the FDA’s November enforcement deadline.

Speakers

Brian Recchione, ImmunoGen (now part of AbbVie)

Brian Recchione
Director, Supply Chain at ImmunoGen (now part of AbbVie)

Ulpiano Flores, Converge Consulting

Ulpiano Flores
Consultant, Converge Consulting

Ulpiano Flores works with leading life science companies through the buildout of serialization systems to meet DSCSA requirements. Flores supports Converge clients by performing serialization gap assessment and strategy design, system implementation and on-going serialization maintenance. He is also a certified TraceLink Administrator.

Register Today