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The Importance of Training to Partner Effectively With Pharma Regulatory Teams

Posted by | 10:38am on Monday, November 19, 2012
giant gavel of justice at the Ohio Judicial Center in Columbus

77% of regulatory professionals are concerned that agency programs and materials could be sources of trouble in litigation 

At a recent conference, Alan Bergstrom, Senior Director of Commercial Regulatory Affairs at Daiichi Sankyo, Inc. announced a new regulatory initiative. He is leading a training and testing program for marketing, managed care marketing and sales training staff (as well as agencies) on basic FDA regulation of advertising and promotion. Staff members will be required to participate before being allowed to initiate promotional tactics and take part in a Promotional Review Committee. He wants to ensure a baseline level of knowledge throughout the company and their partners.

Why this focus on the need for training and testing? More than three-quarters of promotional regulatory professionals say that 21-40 hours are lost each month rewriting promotional materials submitted by untrained agencies. This is from a statistically significant survey of regulatory professionals fielded by Rx Compliance Report at the May 2010 Drug Information Association Conference. That’s an estimated $200,000 wasted in regulatory staff time each year. This doesn’t even take into account the time lost by legal, compliance or marketing. In addition, 77% of regulatory professionals are concerned that agency programs and materials could be sources of trouble in litigation.

This data is surprising to me, as one of the essential obligations we have to our clients as agency partners is to provide compliant solutions. Working within these complex regulatory parameters forces us to be even more creative. This is one of the reasons I find my job so interesting–we can’t just push the “easy button.” When we understand the regs, we are more valuable partners to brand teams.

Would you pass the test?
This research shows the importance of training and testing agency partners on the existing regulations. Over the past few years, Siren has invested in education with the Center for Communication Compliance (CCC): we are certified in Internet promotion/social media and patient relationship marketing. This means that key staff members have passed two comprehensive certification tests developed by former FDA officials to prove that we understand the regulatory fundamentals. Test your basic knowledge by taking a sample test. Results, which are anonymous, are available immediately.

Reap the rewards
Siren works with our brand partners to communicate early and often with the medical, legal and regulatory groups. This collaboration enables us to offer compliant and effective solutions that can help to drive the business.

When marketing and its agencies collaborate to increase regulatory knowledge, companies see the following three benefits:

  • Marketing efficiency: Fewer rewrites, shorter review cycles with less drain on resources
  • Marketing effectiveness: Fewer nonstarter ideas, more time to review other projects in queue and fewer campaigns pulled
  • Marketing impact: Accelerated solutions, getting comprehensive information into the hands of patients faster

Do you agree?

(Image courtesy of Sam Howzit on Flickr).

About Katie Mihelich

Honored by the Healthcare Businesswomen’s Association as a 2007 Rising Star, Katie heads the account services department. She acts as a trusted advisor for Siren’s clients and has developed strong relationships, some of which have lasted for more than ten years. Her strategic leadership and deep understanding of the pharmaceutical industry have played a key role in the impressive growth of the agency.

View other posts from Katie

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