BIO Professional Development

Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth

U.S. Regulatory Environment

Overview of the government agencies/trade organizations that “regulate” drug and medical device promotion: FDA; OIG; PhRMA; AMA; and ACCME. 

    BIO-CCC Online Learning

    Takeaways

    • There are specific government agencies and trade organizations responsible for drug and medical device promotion  
    • The Food Drug Administration (FDA), Office of Inspector General (OIG),  Pharmaceutical Research and Manufacturers of America (PhRMA), American Medical Association (AMA), and  Accreditation Council for Continuing Medical Education (ACCME) each play a distinct role 
    • It’s important to understand these groups’ policies, guidances, and codes 
    Course Price:
    $200 USD
    BIO Member Price:
    $160 USD
    Course Length:
    30 minutes
    Course Level:
    Introductory
    Course Format:
    On-Demand
    Related Courses
    FLIP

    A good regulatory strategy is essential to a good business strategy.

    Professional Certificate
    FLIP

    Do we correct information about our drug in a company’s sponsored chat room? What types of websites shouldn’t we link to? Learn the FDA regs and more.

    FLIP

    Under what conditions can companies find a safe harbor for communicating investigational data?   How and why is scientific exchange codified in the Code of Federal Regulations (CFR).  Learn the FDA regs and more.

    FLIP

    What are considered good publication practices for communicating company-sponsored medical research and how do these practices impact publication development and planning?  Learn more in this pub planning module.