This is a “sponsored” essay, which simply means it is free to everyone and does not count against their one free essay per month for those who are not full subscribers. The reason for that is to maximize the number of people who have the opportunity to tell the FDA how they are progressing toward the DSCSA serialization deadline, and do so anonymously.
What problems are you experiencing? What do you think is going to happen over the next eight years? How do you interpret some of the confusing parts of the law? How do you plan to comply?
The survey is open to everyone whether you are a member of the supply chain, a consultant, solution provider or academic. It is designed to collect your thoughts on some of the issues related to US pharma traceability. And for members of the US supply chain, there are questions about your company’s progress toward readiness for the Drug Supply Chain Security Act (DSCSA) serialization deadline, which is November 27, 2017. (Click here to begin.)
The results of the survey will be published in a report and made available to everyone, free of charge (free registration may be necessary) in Q1 next year. The survey is “blind”, which means there are no questions designed to identify who you are, except to identify your general role in the area of pharma traceability. (Click here to begin.)
Survey’s like this one play an important role in supporting your efforts by informing you and your peers-and regulators including the FDA-about how the industry is progressing toward meeting the next milestone of the DSCSA. Regulators need this kind of window into how things are proceeding and what problems companies are facing so they have time to properly react to the actual outcome as the deadline approaches. So be honest and be complete. Make liberal use of the optional comment boxes on every question to provide additional explanations and clarifications. (Click here to begin.)
The survey will be open at least through the end of December so make use of some of the holiday quiet time to contribute your thoughts and experiences by filling out the survey. Then watch for the report next year. We have Frequentz to thank for sponsoring the annual survey for all three years of its existence. Their interest in helping the industry understand the regulations and meet them extends well beyond just selling solution software. Their sponsorship is what makes this survey and the report possible. Make sure to thank them the next time you see them at a conference.
Thanks for your time, and click here to begin.