Sponsored: FDA Speaks About DSCSA At HDA
Dr. Ilisa Bernstein of the FDA spoke about the DSCSA at the HDA Traceability Seminar
Dr. Ilisa Bernstein of the FDA spoke about the DSCSA at the HDA Traceability Seminar
The two days after the next FDA DSCSA Public Meeting, IQPC will hold their Pharmaceutical Traceability Forum | Interactive event in Washington DC. The FDA meeting will be on December 5 and 6, and the IQPC event will be on December 7 and 8. Perfect for attending two vitally important meetings, and only having to travel once. … Continue reading Sponsored: FDA DSCSA Public Meeting Q&A
A “product grouping” is any collection of saleable units of products that are bound together in some way. They can be “bundles”, homogeneous or non-homogeneous cases, totes, pallets or something like these. The pharma serialization regulations in some markets call out some of these groupings for special treatment, and some do not. I’ll try to … Continue reading Serializing Product Groupings Under Global Regulations
Last week the Healthcare Distribution Alliance (HDA) (formerly the HDMA) held their annual Traceability Seminar in Washington DC. More than 450 people registered, shattering the previous record set just last year (see “Aggregation –> Chargeback Accuracy –> ROI”) and nearly equaling the record set in March for their 2016 Distribution Management Conference and Expo (see … Continue reading HDA Delivers Home Run To Record-Breaking Audience
At the recent HDMA Distribution Management Conference, LSPediA spent a lot of time talking to distributors, wholesalers, and manufacturers about the 2017 deadlines and found a wide range of answers, from “on schedule and feeling confident” to “behind schedule and getting concerned.” But let’s put aside your status for a moment and consider the broader … Continue reading Sponsored: DSCSA Serialization Update: Where We are Now and How to Prepare for What’s Next
Ever since the E.U. Falsified Medicines Directive (FMD) was passed in 2011 my European friends have touted the fact that their government mandated solution would take a “bookend” approach. The implication was always that it would be much less complex than the ePedigree approaches that were being planned by various U.S. states, and then by … Continue reading EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary
According to the HDMA, their Distribution Management Conference and Expo in San Antonio last week broke the attendance record at more than 500 attendees, but for the life of me, I can’t figure out why the number wasn’t double that amount. When you compare the value you receive by attending this (or any) HDMA event with … Continue reading HDMA DMC Serves Sizzling Steak With A Small Side Of Snake Oil
Over the next few years, the U.S. drug wholesale distributors are going to start dictating their specific requirements related to the Drug Supply Chain Security Act (DSCSA) to their suppliers. For the “Big 3” U.S. wholesale distributors, those suppliers happen to be nearly every drug manufacturer who markets drugs in the United States. The “Big 3” … Continue reading U.S. Drug Wholesale Distributors Provide Direction To Manufacturers
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