Tag Archives: IQPC

Sponsored: Extracting Value Beyond Compliance From Serialization

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

Sponsored: Newly Updated Global Serialization Regulation Map

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

Sponsored: Interview With Four Pharma Supply Chain Thought Leaders

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

Sponsored: Dispenser Perspectives On The DSCSA: An IQPC Interview

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.

Continue reading Sponsored: Dispenser Perspectives On The DSCSA: An IQPC Interview

Sponsored: Anti-counterfeiting Successes and Failures Around the World

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

Sponsored: FDA Speaks About DSCSA At HDA

Ilisa Bernstein, Pharm.D., J.D., FDA

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.

Continue reading Sponsored: FDA Speaks About DSCSA At HDA

Sponsored: FDA DSCSA Public Meeting Q&A

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.  The Pharmaceutical Traceability Forum | Interactive event includes a slate of excellent speakers who will provide you with their immediate impressions of the FDA meeting that will have just occurred, and the one that was held back in August (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals”). Continue reading Sponsored: FDA DSCSA Public Meeting Q&A

Sponsored: Don’t Miss These Back-To-Back Pharma Serialization and Tracing Events

There is a rare alignment of events that will happen in the first week of December that is so special that you need to put it on your calendar.  There are two important pharma serialization events that will occur in the Washington DC area and anyone with a serious interest in that subject should attend both.  These events line up perfectly to allow you to travel once, and spend four days that will solidify your understanding of the issues and opportunities embedded within the Drug Supply Chain Security Act (DSCSA) in particular, and pharma serialization in general. Continue reading Sponsored: Don’t Miss These Back-To-Back Pharma Serialization and Tracing Events