DIA Pharmacovigilance and Risk Management Strategies Meeting

I attended the DIA Pharmacovigilance and Risk Management Strategies meeting this week in Washington, DC.  The meeting’s focus was a combination of risk management planning, drug safety, novel data mining methods for signals and evidence including social media and emerging markets.


One takeaway thought I had was in regards to the safety updates downstream and its impact to the drug product label. That made me think about how pharmaceutical companies can make the management of these impacts more transparent to the organization while increasing the efficiency by which they are implemented globally. With these critical updates the drug label helps manage the safety, awareness and communication to the physician and worldwide patient population.

Managing global labeling changes efficiently within the complex, regulated, large global pharmaceutical organizations is no easy task. The risk of not having the right solutions in place to manage the risk of request errors, breakdown in process, non-compliance to company SOP’s and proper workflow all has serious implications both legally and from a regulatory perspective. With this tsunami of safety data to manage, the need to globally protect and harmonize organizations while delivering critical up-to-date healthcare information efficiently to a worldwide patient population is more important than ever.

Is your organization as prepared for efficient labeling updates as it could be?  http://www.intagras.com


Rob Leonetti, VP, Intagras

FDA Requires Unique Device Identification | Intagras Blog

On Tuesday, September 24th 2013, the Department of Health and Human Services (HHS) published the following in the Federal Register Volume 78, Number 185, Part V, requiring a Medical Device Unique Device Identification System.

The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA’s Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. This rule will go into effect on December 23rd, 2013.

The FDA is expected to release a technical implementation guide that will define the electronic submission message format that will be used to implement this rule. I anticipate that most of the data required by the FDA already exists within applications and systems utilized by medical device companies. Some of the aforementioned systems will probably require some additional data elements such as the UDI, so that an association can be made with each medical device. But I do not anticipate that medical device companies will need to create much “new” data regarding their products. The challenge facing medical device companies will be the creation, maintenance, and validation of submission data in structured product labeling (SPL) format. I anticipate that medical device companies will be best served by making minor modifications to their existing systems to support any new data, and updating their standard operating procedures to remain compliant with the new rule. Additionally, the creation and validation of the actual SPL submission would be most efficiently done by mapping existing data to a proven SPL software product, where the implementation guide technical and regulatory rules can be managed so that validation can happen and the submission generated. This approach will allow medical device companies to quickly implement a solution with minimal impact to existing processes and systems.

In the event a medical device company does not have existing systems containing the required data, or if it would be more effective to adopt a new system to manage and validate this data and allow for submission creation, these companies should evaluate SPL software that provides these full capabilities to ensure the highest level of compliance with the rule as it currently is, and allows for updates as the implementation guide is updated and business rules are modified. These types of updates are inevitable and have been seen in the pharmaceutical product and establishment registration implementation of SPL.

Link to the Federal Register Volume 78, Number 185, Part V: http://www.gpo.gov/fdsys/pkg/FR-2013-09-24/pdf/2013-23059.pdf#!

For more additional information, please feel free to contact me at info@intagras.com.

Craig Trautman

SPL grapic on FDA utilization

Here is an e-mail that was sent out by Lonnie Smith of the FDA. The e-mail provides a link that has a graphic of how three different Federal government agencies may utilize a single product SPL file for different purposes.

***** Begin E-mail from FDA ******


Here is a hyperlink to an SPL-Infographic which depicts how three different Federal government agencies may utilize a single product SPL file for different purposes:


Lonnie Smith

Interesting Article

I was forwarded this Government Accountability Office (GAO) report from one of the other members of the SPL Leadership Team. GAO was mandated to examine the benefits and efficiencies of electronic labeling as a partial or complete substitute and its impact on public health. Because drug labeling is already available in electronic form, representing a partial substitute, this report focuses on (1) the advantages and disadvantages of relying on electronic labeling as a complete substitute for paper labeling and (2) the barriers associated with relying on electronic labeling as a complete substitute for paper labeling. GAO interviewed federal officials, including those from FDA, and stakeholders representing physicians, pharmacies, patients, drug manufacturers, and drug labeling manufacturers. GAO also reviewed relevant FDA guidance documents and regulations.

It is exciting to see that the FDA is continuing to expand electronic labeling! Enjoy!

Full report (25 pages)


Highlights  (1 page):