U.S. Regulatory Compliance eLearning Courses
Purchase the 18-course track bundle and save on enrollment fees
Browse the selection of online courses below, or click here to view all Center for Communication Compliance course offerings.
Description: Overview of the government agencies/trade organizations that “regulate” drug and medical device promotion: FDA; OIG; PhRMA; AMA; and ACCME.
- Module Length: 30 min
- Price: $200
- BIO Member Price: $160
Description: Detailed review of content do's and don'ts including comparative/superiority, charts/graphs, competitor information, “cherry-picking”, disclaimers, references, market research data, quality-of life claims, company spokespeople.
- Module Length: 30 min
- Price: $200
- BIO Member Price: $160
Description: Effectively communicate risk information, such as the definition and execution of fair balance in promotional materials. Learn common terms such as Brief Summary, Boxed Warning, Important Safety Information, Adverse Event reporting - plus enforcement letters illustrating the application of these requirements.
- Module Length: 15 min
- Price: $145
- BIO Member Price: $115
Description: FDA Guidances relevant to a specific discipline (Ad Promo, Digital, Public Relations, or Promotional Med Education).
- Module Length: 30 min
- Price: $200
- BIO Member Price: $160
Description: FDA Guidances relevant to a specific discipline (Ad Promo, Digital, Public Relations, or Promotional Med Education).
- Module Length: 30 min
- Price: $200
- BIO Member Price: $160
Description: FDA Guidances relevant to a specific discipline (Ad Promo, Digital, Public Relations, or Promotional Med Education).
- Module Length: 30 min
- Price: $200
- BIO Member Price: $160
Description: FDA Guidances relevant to a specific discipline (Ad Promo, Digital, Public Relations, or Promotional Med Education).
- Module Length: 30 min
- Price: $200
- BIO Member Price: $160
Description: Comprehensive review of the Do's and Don'ts for AD/Promo Tactics: covers types of drug and medical device advertising (disease state/unbranded, product/branded, reminder, institutional, recruitment), promotional labeling (booklets, brochures, direct mail, exhibit booths, file cards, monographs, publications, sales aids, videos).
- Module Length: 30 min
- Price: $200
- BIO Member Price: $160
Description: Comprehensive review of the Do's and Don'ts for AD/Promo Tactics: covers types of drug and medical device advertising (disease state/unbranded, product/branded, reminder, institutional, recruitment), promotional labeling (booklets, brochures, direct mail, exhibit booths, file cards, monographs, publications, sales aids, videos).
- Module Length: 30 min
- Price: $200
- BIO Member Price: $160
Description: Comprehensive review of the Do's and Don'ts for Digital Tactics: covers drug and medical device advertising, blogging, chat rooms, discussion forums, Facebook and Twitter, links, search (paid and organic) posts, videos, websites, mobile apps, YouTube.
- Module Length: 30 min
- Price: $200
- BIO Member Price: $160
Description: Comprehensive review of the Do's and Don'ts for Digital Tactics: covers drug and medical device advertising, blogging, chat rooms, discussion forums, Facebook and Twitter, links, search (paid and organic) posts, videos, websites, mobile apps, YouTube.
- Module Length: 30 min
- Price: $200
- BIO Member Price: $160
Description: Comprehensive review of the Do's and Don'ts for Public Relations Tactic: covers drug and device promotion, including press releases, VNRs, media tours, web sites and webcasts, spokespeople, media training, sponsored content/advertorials.
- Module Length: 30 min
- Price: $200
- BIO Member Price: $160
Description: Comprehensive review of the Do's and Don'ts for Public Relations Tactic: covers drug and device promotion, including press releases, VNRs, media tours, web sites and webcasts, spokespeople, media training, sponsored content/advertorials.
- Module Length: 30 min
- Price: $200
- BIO Member Price: $160
Learn the Do's and Don'ts for Promotional Medical Education: Covers drug and device promotion, including speaker's bureaus, presentations at scientific meetings, contractual arrangements with speakers, consultants, ad board members, publication plans, speakers' fees, slide kits, gifts to HCPs, events, sponsorships, MOA.
- Module Length: 30 min
- Price: $200
- BIO Member Price: $160
Comprehensive review of Do's and Don'ts for Promotional Medical Education. Covers drug and device promotion, speaker's bureaus, presentations at meetings, contractual arrangements with speakers, consultants, ad board members, publication plans, speakers' fees, slide kits, gifts to HCPs, events, sponsorships, MOA.
- Module Length: 30 min
- Price: $200
- BIO Member Price: $160
Detailed review of the Pharma Code from the Pharmaceutical Research and Manufacturers of America (PhRMA) representing research-based pharmaceutical and biotech companies. Covers selection, use and training of promotional education speakers and hiring of HCPs as consultants; comparative claims, promotional publications, videos and visuals, meeting venues, meals, events and gifts.
- Module Length: 15 min
- Price: $145
- BIO Member Price: $115
Description: Overview of Physician Payments "Open Payments Program" (Sunshine Act), which requires manufacturers of drugs, medical devices/ biologicals that participate in U.S. federal health care programs to report certain payments/items of value given to physicians/teaching hospitals.
- Module Length: 30 min
- Price: $200
- BIO Member Price: $160
Description: Overview of Federal Health Insurance Portability and Accountability Act (HIPAA). Primary goal of the law is to make it easier for people to keep health insurance, protect confidentiality/security of healthcare information and help the healthcare industry control administrative costs (with 10-question quiz).
- Module Length: 30 min
- Price: $200
- BIO Member Price: $160
Description: Includes all 18 courses listed above in the U.S Regulatory Compliance course track.
- Module Length: 7.5 hours
- Price: $2,792
- BIO Member Price: $2,232
CCC content is developed by members of the CCC Advisory Board, which is composed of former government officials and healthcare compliance officers, regulatory experts, and lawyers.
Drug and medical device companies expect their account teams to demonstrate mastery of regulatory compliance fundamentals. CCC administers Regulatory Compliance Tests (RCTs) to confirm that employees understand compliance principles in a practical way and can actively apply them to the design and execution of promotional marketing campaigns. Comprehensive reports include questions most frequently missed for professional development.
For questions regarding CCC coursework or pricing, please contact BIO Online Learning Support at courseshelp@bio.org
Coursework is accessible through the CCC website using confidential passcodes. After purchasing your course through BIO's website, you will receive your passcode and login information via email from CCC. To purchase a course, please complete the course order form.
