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2day Inperson Seminar on Advertising and Promotional Requirements for Drugs and Medical Devices

9/4/2014 9:00 AM - 9/5/2014 6:00 PM


The FDA regulates the promotion of prescription drugs, biologics, medical devices and biotechnology products to ensure that the information is not false or misleading. The FDA has for decades regulated traditional advertising for decades, published various guidance documents for industry and issued many violation letters. If the FDA determines that drug or medical device promotional material is false or misleading or lacking in fair balance as between benefits and risks, companies could be forced to implement costly corrective actions, such as remedial advertising, suffer damage to their reputations and incur monetary fines. Already, the government has collected billions of dollars in fines, forfeitures and disgorgements from drug companies for the alleged marketing of a product for unapproved, or "off-label," uses.

Course outline/Agenda:

Day One

Lecture 1: Required Elements of All Advertising and Promotional Materials for Drugs and Medical Devices

Lecture 2: Promotion, Labelling and Advertising

Lecture 3: Misbranding/Off-Label Information and Issues

Lecture 4: FDA Enforcement Surveillance

Lecture 5: Social Media

Lecture 6: Enforcement Tools

Lecture 7: The FDA has an escalating arsenal of enforcement tools from informal notices to formal administrative notices to civil actions and finally to criminal prosecution.

Lecture 8: Untitled Letter and the Warning Letters

Lecture 9: Seizures

Day Two:

Lecture 10: Injunctions/Consent Decrees

Lecture 11: OIG/DOJ/False Claims Act and Other Acts and OIG Settlements/CIA's

Lecture 12: Physician Payments Sunshine Act

Lecture 13: The federal Anti-Kickback statute presents many potential pitfalls for medical device manufacturers looking to promote their products.

Lecture 14: Disclose risk information in prescription drug and medical device promotion appropriately and effectively to healthcare professionals and consumers

Lecture 15: Company Policies and Procedures

Lecture 16: AdvaMed Code of Ethics on Interactions with HCP's

Lecture 17: Integrating FDA compliance elements into Healthcare Compliance or Corporate Compliance programs and overview of the standards with HHS-OIG Guidance

Lecture 18: Recent Trends and Enforcement Actions

Instructor/Speaker Profile:

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He has been involved in many FDA and other regulatory inspections as well as part of multiple FDA remediation activities involving CIA's Consent Decrees, Seizures and other enforcement actions, including responding to Warning Letters. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, addresses all aspects of postmarketing requirements involving advertising, promotional and labeling claims, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.

Date, Venue and Time:

Location: Chicago, IL

Date: September 4th and 5th, 2014

Time: 9 am to 6 pm EDT

Venue: Courtyard Chicago O'Hare

Address: 2950 S. River Road Des Plaines Illinois 60018 USA

Price: $1295.00 (Seminar for One Delegate)

Discount: Register now and save $200. (Early Bird)

Until August 15, Early Bird Price: $1,295.00

From August 16 to September 02, Regular Price: $1,495.00

Contact Information:

John Robinson

Toll free: 1800-447-9407

Fax: 302-288-6884



Live Chat - Online Help Desk:


NetZealous LLC

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

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