Compliance News in Review, May 16, 2016
Medicines for Europe adds transparency requirements to its Code, Aegerion settles with the DOJ and SEC, and the interim president of Brazil addresses anticorruption. Any doubt the summer blockbuster...
View ArticleNews in Review, June 15, 2016
Federal investigators subpoena information related to charitable organizations from three companies, Congress proposes a an amendment to the FDCA, the head of the FDA speaks on off-label information,...
View ArticleBuy or Build: Is Off-the-Shelf or Custom Online Compliance Training Right for...
During a recent compliance conference panel session, a chief compliance officer from a mid-size pharmaceutical company proclaimed, “I only use custom online training,” and “off-the-shelf just doesn’t...
View ArticleCompliance News in Review, July 5, 2016
Another organization calls for a ban on Direct to Consumer advertising, two former industry sales reps are arrested for kickbacks, a former executive is acquitted on kickback charges, and CMS releases...
View ArticleThe Right Stuff: Compliance Training in Preparation for Your Company’s First...
A first product launch is an exciting and overwhelming for any life sciences company. So much to do, and what seems like so little time to do it – especially if you are a compliance department of one...
View ArticleCompliance News in Review, July 14, 2016
The Serious Fraud Office has its second application for a DPA approved, CMS solicits feedback, and experts are dismissed from an advisory panel due to perceived conflicts. It’s hot, it’s humid, and the...
View ArticleExcel for Tracking Training? Been There, Done That, and Sadly, I Have the...
As someone who worked in compliance for a small life sciences company, I like to share the problems and pitfalls I experienced over the years, in the hope of saving others from the same fate. Today, we...
View ArticleCompliance News in Review, July 26, 2016
Executives on trial, an FCA settlement, a “clarification” to a change in the District of Columbia detailer law, and an Open Payments open forum…all in this edition of the Compliance News in Review....
View ArticleTo Use Employees as Actors for Compliance Training or Not: That is the Question
Shakespeare said, “All the world’s a stage,” but when that stage is your training video, should your colleagues be the players? Before taking the leap and giving employees their “fifteen minutes,” you...
View ArticleCompliance News in Review, August 19, 2016
The Pfizer shareholder suit settlement, Open Payments Open Forum, Robert Callif addresses sharing truthful off-label information, a whistleblower suit, and it’s always Sunshiney in Germany in this...
View ArticleCompliance News in Review, August 25, 2016
Here’s the tune we’re whistling this week: a California state senator pulls his own proposed transparency bill; an analysis of the FDA user fee programs yields interesting information; former Insys...
View ArticleMaking the Most of Face-to-Face Time with Learners
by Lauren Barnett Time in front of learners is a valuable commodity. Everyone throughout your organization is busy with his or her designated responsibilities, and the demands on a learner’s time makes...
View ArticleCompliance News in Review, September 15, 2016
Illinois tackles illegal drug promotion by Insys; the ABPI calls out two member companies for breaking promotion rules; the Australian legislature shines a light on corporate crime and Medicines...
View ArticleDiscount Registration: Pharmaceutical and Medical Compliance Congress
The 17th Annual Pharmaceutical and Medical Device Compliance Congress is scheduled for October 19-21 and the PharmaCertify team is looking forward to catching up with colleagues and sharing demos of...
View ArticleThe Pharmaceutical and Medical Device Compliance Congress: A Preview
The Seventeenth Annual Pharmaceutical and Medical Device Compliance Congress gets underway in just a few short weeks. The annual gathering provides an opportunity for industry professionals and experts...
View ArticleCompliance News in Review, October 14, 2016
Ghouls, goblins and ghosts galore…the haunting season is here! Enjoy it while you can, before you know it, reindeer, snowmen, and gingerbread men will be scattered across the landscapes. (Poor...
View ArticleNotes and News from the Seventeenth Annual Pharmaceutical and Medical Device...
If the overriding theme of the Seventeenth Pharmaceutical and Medical Device Compliance Congress could be summed up in three phrases, they might be “partnering with the businesses,” “a seat at the...
View ArticleCompliance News in Review, November 18, 2016
Bring on the turkey, cranberries and uncomfortable family interactions! Thanksgiving is almost here. Soon enough, the stress of all that preparation will melt away as we share meals with friends and...
View ArticleCompliance News in Review, December 12, 2016
If you’re dancing “The Beagle,” and you can’t break away from all of the movies starring Candace Cameron Bure on the Hallmark Channel, it can only mean one thing; it’s Christmas time! Despite what...
View ArticleCompliance News in Review: the 2016 Year-End Summary
Here we are again. Another 584 million-mile (940 million km for our metric friends) trip around the sun is nearly complete. It seems like just yesterday we were celebrating the beginning of 2016 and...
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