Tag Archives: SOP

From Policy to Behavioral Change: 4 How-Tos from ex-AIG CCO


“Policies are not enough,” said Suzanne Rich Folsom, former Chief Compliance Officer for AIG, speaking at the recent Dow Jones Global Compliance Symposium .

Policies are only the very first step in an organizational culture that is truly compliant with regulatory requirements. If you want to protect your company, here are four insightful how-tos from Suzanne Rich Folsom and other @dj_gcs speakers to move your policies from paper documents to meaningful behavioral change: Continue reading

Regulatory and Marketing Symbiosis from Concept to Launch: How-To RAPS Webinar

Common Clownfish (Amphiprion ocellaris) in the...

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Register now on RAPS.org

Date: 30 June 2011
Time: 12:00–1:30pm EDT

Regulatory and marketing are the two internal departments at the center of the development and approval of product claims at medical device and diagnostics companies. Product claims are the lifeblood of promotion during commercial launch and beyond. Regulatory presents the point of view of the US Food and Drug Administration (FDA) and other governmental bodies as to the rules and regulations surrounding promotion, education and scientific exchange. Marketing is the voice of the customer—physicians, healthcare providers, patients, payers—as well as sales. In short, regulatory must ensure that the company and patients are safe while marketing must advocate for healthcare providers, sales and revenue generation. This has historically put these important departments at cross-purposes. Continue reading

9 Notable Insights from AMEX and Putnam on Social Media & Reputation


Do you know what “astroturfing” is? If not, read on to learn nine (9) notable insights I gleaned from an esteemed panel at Dow Jones Compliance Symposium discussing how to protect your company’s reputation on the social network:

From Mark Bisard, American Express:

1. Require legal counsel employees to get social media accounts so they are credible advisors.

2. Take the time to develop a comprehensive, collaborative social media policy that combines disparate policies spread across geographies. For example, It took AMEX a year and a half to work with all the right stakeholders to develop a great policy.

3. “Disclose and Disclaim”: Disclose who you work for and disclaim that your views are your own anytime you mention anything remotely related to the company. Continue reading

Roche’s Social Media Approval Process


Most communication or content approval processes within regulated industries such as pharmaceutical, medical device and biotech companies are set up for maximum accuracy and rigor vs. maximum speed regardless of medium of communication.   However, with the need for speed in social media, is there a compliant middle ground?  As discussed by Elsa and by both Elsa and me in our recent RAPS webinar (free access until 03/31/11), we suggest that one way may be sufficient documentation and pre-approval of certain types of social media by certain highly trained individuals.  As such, I thought you all would be interested in learning Roche’s best practices for social media approval from their well-thought out Social Media Guideline. Continue reading

5 Short and Sweet Tips for Content Review


If you don’t have the time to sit through a webinar (they are about an hour), here are five short and sweet practical basics I learned while going through the creation and management of a cross-functional promotional review committee (PRC): Continue reading