Tag Archives: IQPC

Sponsored: Pharma Traceability

May 22-24, Hotel Del Coronado, Coronado, CA

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

Sponsored: The Season For Label Redesign

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

Sponsored: Monitor Your Product. Manage Your Brand.

Dear Colleague,

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.

Sponsored: Will Global Serialization Mandates Result In Less Counterfeiting?

iqpc-acf-sidebar-banner-1One 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?

Sponsored: Interview With Two Pharma Supply Chain Thought Leaders

iqpc-nov16-336x280The 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

Sponsored: Brazil Officially Suspends All Remaining Serialization Deadlines Of RDC-54

iqpc-serial-labeling-playbook-2016Apparently, the National Agency of Sanitary Surveillance (ANVISA), Brazil’s pharma regulatory body, has passed a resolution that finally suspends all remaining serialization deadlines that were left over in their old RDC-54 regulation.  Remember that they suspended the deadline for the 3-lot pilot from RDC-54 last year (see “The Official Suspension of the Three-Lot Pilot in Brazil“).  I consider this news to be a “rumor” only because I have not yet seen the official word, despite having heard it from a very reliable source.

This is not Continue reading Sponsored: Brazil Officially Suspends All Remaining Serialization Deadlines Of RDC-54

Sponsored: Tracking Serialization: 2016 Pharma Trace Market Trends

Tracking Serialization titleDo you know what situation your peers’ businesses are in, and what they’re working to?  To find out just that, IQPC polled their network of pharmaceutical serialization professionals and got responses from representatives of over 20 companies.

The results?  Most find data storage and management to be their biggest issue, citing ERP systems as some of their biggest investments in 2016 and going forward.  It follows that over 50% of those we polled are either implementing their strategies in multiple sites or already done and thinking beyond compliance.

IQPC also asked about their biggest inhibitors, their current and future budgets, and their experience with international compliance.  If you want to find out what your peers think about these topics, you can download the survey report, or meet them on-site at the Pharmaceutical Traceability Forum, May 23 – 25 in Philadelphia.  Use the discount code PT_RXTRACE to get 20% off the standard price! Continue reading Sponsored: Tracking Serialization: 2016 Pharma Trace Market Trends

Sponsored: Pharma Serialization Deadlines In Flux

iqpc.zoomThe industry is rife with rumors that Brazil’s ANVISA has made the decision to push out their serialization deadline for multiple years—and perhaps redefine the requirements.  I cannot confirm any of these rumors at this point and I do not recommend acting on rumors.  I suggest you continue down the path of meeting the existing, known regulation until—if ever—you get the official word from an official publication of ANVISA.  Who knows when that might occur.  If/when you see something official, let me know. Continue reading Sponsored: Pharma Serialization Deadlines In Flux