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.
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
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
Pharmaceutical serialization and traceability laws continue to be developed all over the world. In any one market, it takes several years to progress from the initial stirrings to the publication of full, workable regulations. As we have seen, several countries have had to take a few steps back, make adjustments and then move forward again (see “Brazil Gets Rational With Their New Pharma Traceability Law” and “China’s Retreat From Pharma Serialization: Will This Become A Global Trend?”). In fact, I think those countries that do, will end up with a much better approach.
What that means to you is Continue reading Sponsored: Pharma Traceability
With the approach of pharma serialization deadlines all around the world, this is the season for label redesign. The addition of new unique identifiers in 2D barcodes and human readable forms—often without removing existing linear barcodes—requires knowledge of the pharma labeling regulations in the target markets as well as artwork skills (see “DSCSA: Label Artwork Heartaches”). The problem is, serialization doesn’t apply to just one product, it applies to all prescription drugs marketed in the target market. That threatens to cause Continue reading Sponsored: The Season For Label Redesign
We recognize that counterfeit and grey market products pose tremendous risks, both to consumer safety and to your business’ bottom line. The 6th Pharma Anti-Counterfeiting & Brand Protection Summit takes a comprehensive approach to understand the latest regulations for the DSCSA to remain compliant and uphold quality through brand protections plans, anti-counterfeiting strategies, and effective partnerships.
Key Highlights for 2017 include: Continue reading Sponsored: Monitor Your Product. Manage Your Brand.
One of the focuses of RxTrace is to explore global pharma serialization and tracing regulations in an attempt to discover some of their implications. Some implications turn out to be obvious, but some turn out to be surprising. Identifying the implications early provides us with a better understanding of what to expect from our investments in time to fine-tune those investments. If company leaders have a realistic understanding of what to expect from different investments, they will make better decisions for their stakeholders. Can they expect to be fully compliant? Only partly compliant, thus needing to spend more down the road? Will they be fully compliant with the law, but disappoint their primary customers and thus find that their business takes a hit? If they have a good idea of what to expect before they Continue reading Sponsored: Will Global Serialization Mandates Result In Less Counterfeiting?
The 4th Pharmaceutical Traceability Forum will occur on November 30 through December 2 in Philadelphia. Two of the top speakers will be Matt Sample, Senior Director, Secure Supply Chain from AmerisouceBergen, one of the “Big-3” wholesale distributors in the United States, and Christopher Howell, Senior Director, Global Engineering and Technology from Patheon, one of the largest pharma contract manufacturers in the U.S.. Recently, IQPC conducted an interview of both of these supply chain thought leaders. Get a copy of the interviews here. Continue reading Sponsored: Interview With Two Pharma Supply Chain Thought Leaders