Chief Supply Chain Officer
Dispensary of Hope
One State now requires that a pharmacy shall insure the integrity of any drug requiring temperature control that is delivered by mail order by enclosing in each package a measurement device to alert consumers that drugs have been exposed to temperatures that could affect their potency and stability. So how has one of the major pharmacy chains decided to meet that requirement?
12:20 PM Regulatory Briefing: End to End Serialization & Traceability- How can we Meet the DSCSA November 2017 Serialization Requirements and Leverage Value-added Opportunities?
Now that we are up to speed on the “why”, it is time to focus on the “what & when” surrounding serialization. Regulations & guidelines are in practice across the globe, all with different requirements and deadlines, some without much guidance at all. The regulatory landscape is constantly evolving with new regions deciding to jump on the bandwagon and others reworking their current plans. With the US & EU leading the way, it is important to fully grasp the international scope of serialization requirements & reporting to ensure that you are fully compliant in all markets that you conduct business.
What you will learn:
- Overview of the DSCSA & EU FMD deadlines and expectations
- Review the regulatory changes coming out of Brazil, Russia & India
- How will emerging markets in the Middle East & Africa decide to map out their guidance’s on tracking and traceability
- Streamline your reporting to the various regions by understanding what is required
- How to ensure data integrity & security when operating in multiple regions