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WOMMA and the Center for Communication Compliance (CCC) have formed a strategic alliance to bring the healthcare industry a new Online Certificate Program focused on regulatory compliance for new and emerging media.
www.communicationcompliance.com/go/Static/curriculum_soci...
Entitled Regulatory Compliance 101: Internet Promotion and Social Media, this first-of-its-kind online certificate program is based on a "train + test" methodology designed to help reduce violative materials, decrease legal vulnerability, and support a culture of compliance.
ABOUT THE PROGRAM
Upon completion of the WOMMA Online Certificate Program in Internet Promotion and Social Media, you will have answers to:
* How can you promote prescription products online these days with all the limiting regulations? What can you really do in social media that is not violative of FDA DDMAC regulations? Said another way, which social media strategies can be implemented that are in compliance with FDA's regulatory framework?
* What are the regulatory implications of the space and time limitations inherent in many social media channels? How do these constraints affect online promotion today and what new issues may arise from a regulatory perspective?
* FDA has guidelines about format/layout/typography/white space in regard to print ads … how will these "implementing factors" play out in social media and Web sites, which are so different from print?
The program is designed to help marketers understand the rules and guidelines imposed by regulatory agencies, industry associations, and trade groups:
* Food and Drug Administration (FDA)
* Office of the Inspector General (OIG) of the Dept. of HHS
* Department of Justice (DOJ)
* Pharmaceutical Research and Manufacturers of America (PhRMA)
* Accreditation Counsel for Continuing Medical Education (ACCME)
* American Medical Association (AMA)
COURSE CONTENT
* Understand the U.S. healthcare regulatory environment as it relates to sponsored and unsponsored promotion, on the Internet Promotion (Web sites, banner ads, search engine ads, search engine optimization) and Social Media (e.g., Facebook, Twitter, YouTube, chat rooms, SideWiki)
* Who's Watching – the key regulatory authorities (e.g., FDA/Bad Ad Program; OIG)
* Fundamental compliance considerations
* Discussion of FDA/DDMAC action related to Internet promotion to-date
* Enforcement examples, including
-- Untitled letter to Novartis for Tasigna® (nilotinib) Capsules -- Facebook “Share” widget on US product Web site (HCP & Consumer)
-- Warning Letter to Novartis for Gleevec® (imatinib mesylate) -- Novartis-sponsored Web sites (www.gistalliance.com; www.cmlalliance.com)
-- 14 Untitled Letters on search engine marketing
-- Other related enforcement
1. Shire (Adderal®) YouTube Video
2. Ultram ER® Webcast
3. Novartis (Diovan®) Banner Ad
4. Latisse® Web site
5. Sotradecol® Web site
WHO SHOULD PARTICIPATE
Any professional in the pharmaceutical, biotech or device industry, who works with, designs, executes, reviews, or oversees Internet promotion or social media programs.
HOW DOES THE PROGRAM WORK
* Approximately 2 hours; 24/7 access from WOMMA's partner, CCC
* Course content correlates to the Regulatory Compliance Test (RCT)
* Forty (40) test questions: multiple choice, true/false
COST
WOMMA member companies can register at a significantly discounted rate and volume discounts are available. If you're not a member of WOMMA but would like to join before enrolling in this certificate program to take advantage of these discounts, please contact Tarah Remington Brown, Director of Member Relations at Tarah@WOMMA.org or call 312-853-4400.
INSTRUCTORS
Tracy Acker, PharmD:
President of The Acker Group. Served as Branch Chief in FDA's Division of Drug Marketing, Advertising and Communications (DDMAC). Former Executive Director of Regulatory Promotion at Amgen and Director of Regulatory Affairs for Advertising and Promotion at Johnson & Johnson.
Arnie Friede:
Principal of Arnie I. Friede & Associates. Served as Associate Chief Counsel in FDA's Chief Counsel Office. Former Senior Corporate Counsel at Pfizer, Inc., and former Chairman of Food, Drug, & Cosmetic Law section of NYS Bar Association.
Michael A. Misocky, RPh, JD, CHC:
President of Misocky Consulting Group. Former Regulatory Review Officer for FDA Division of Drug Marketing, Advertising, and Communications (DDMAC). Formerly Assistant VP and Deputy Compliance Officer at ImClone Systems; also worked at Abbott and BMS.
Wayne Pines:
Chair of the CCC Advisory Board. Served at the FDA for 10 years as Chief of Consumer Education and Information, Chief of Press Relations, and Associate Commissioner for Public Affairs. Author of the two-volume FDA Advertising and Promotion Manual, the standard reference in the field.
Astron E-School offers complete Healthcare Audit Certification programs, engaging experts with fundamental abilities in auditing healthcare frameworks. These certifications furnish people with the information and ability expected to survey healthcare processes, guarantee administrative consistence, and improve patient wellbeing. Through Astron E-School's thorough preparation modules, members figure out how to lead careful audits, distinguish regions for development, and carry out powerful answers for advance healthcare conveyance. With Astron E-School's Healthcare Audit Certification, experts can raise their vocations in healthcare quality administration and add to the nonstop improvement of healthcare administrations.
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