In just two months, pharmaceuticals entering the US pharma supply chain through drug manufacturers will be serialized according to the Drug Supply Chain Security Act (DSCSA). It’s already been a long journey, but this is only the beginning. Companies can’t even take a break. In just one year the wholesale distributor saleable returns requirement will force manufacturers to either capture aggregation data or connect to a Verification Router Service (VRS)—or both! The year after that, Continue reading From Serialization to Full Traceability: 2018 Outlook On Compliance
Kevan MacKenzie, Director of Serialization Technology at McKesson, is arguably the leading expert on the Drug Supply Chain Security Act (DSCSA) requirements for wholesale distributors, and interactions with their trading partners. IQPC recently interviewed Mr. MacKenzie to get his perspectives on the biggest challenges companies face when preparing for the DSCSA.
MacKenzie’s insights will Continue reading Sponsored: IQPC: The Biggest Challenges Preparing For The DSCSA
Companies are spending hundreds of millions of dollars, euros, rupees and rubles getting ready to comply with serialization regulatory mandates around the world. Deadlines are fast approaching in the US and the EU and they are already passed in India, South Korea, Argentina and Turkey. What companies are looking for next is how to extract some value beyond just complying with government mandates. Just about every solution provider offering serialization components and solutions out there has at least one product or service that is aimed squarely at this type of need. What we need to do is get these people together: those who are looking, and those who have the solutions.
Cognizant, a management consulting company, has written a very nice 11-page white paper exploring value beyond compliance. Continue reading Sponsored: Extracting Value Beyond Compliance From Serialization
I just helped IQPC update their printable global pharma serialization regulation map. Get a copy here. Things change around the world pretty often so it’s important to update resources like this frequently. The information for most of the existing countries was updated and I added a few new countries. It’s a great resource to print and pin up on your office wall, or the company bulletin board to keep everyone focused on the approaching deadlines around the world. And it looks great too! Continue reading Sponsored: Newly Updated Global Serialization Regulation Map
The IQPC PharmaTrace Summit will be held on June 4-6 in Princeton, NJ. In preparation for the event, IQPC asked four industry veterans to respond to a set of forward-looking questions to get a glimpse of the future of serialization and track & trace in the US pharma supply chain. The four include: Continue reading Sponsored: Interview With Four Pharma Supply Chain Thought Leaders
Many RxTrace readers have a fairly good understanding of the perspective of drug manufacturers and wholesale distributors regarding the Drug Supply Chain Security Act (DSCSA) and its implementation, but dispenser perspectives are not so well understood. Enter IQPC who interviewed Brian Files, Principal Consultant with Healthcare Strategies Consulting Group and former Director, Inventory and Compliance with CVS Health, one of the largest chain pharmacies in the US, to find out his perspectives on the DSCSA.
Governments around the world recognize the problem that the World Health Organization (WHO) once called Substandard/Spurious/ Falsely-labelled/Falsified/ Counterfeit medical products, or SSFFC, but more recently calls Substandard and Falsified medical products. These governments recognize the problem, and their citizens suffer from it, but some of them don’t seem to know what to do about it. Nigeria, Kenya and other countries in Africa have been very assertive in attacking the problems, but other poorer countries without strong central governments can’t afford or don’t have the will necessary to take strong action.
Rich countries impose serialization and tracing requirements, but that only helps to keep the legitimate supply chain clean. Many countries Continue reading Sponsored: Anti-counterfeiting Successes and Failures Around the World
Last week, Dr. Ilisa Bernstein, Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, spoke last week at the Healthcare Distribution Alliance (HDA) Traceability Seminar (see “HDA Traceability Seminar: RxTrace Future Topic List Explodes“). Her presentation went beyond the simple, tight-lipped, high-level review of the Drug Supply Chain Security Act (DSCSA) that is typical of recent FDA presentations at conferences. It was a refreshing change.