Overview:
The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration ("FDA"). How the FDA will deal with such advanced communication technology that can go "viral" and just as quickly disappear is the question that the industry is eager to have answered.
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.
Questions typically addressed, included but not limited, to the following:
· Does the FDA control advertisements for all drugs?
· Does the FDA review and approve all advertisements for drugs before their release?
· Does Federal law ban ads for drugs that have serious risks?
· Does the FDA require drug companies to use hard-to-understand medical language in ads directed to consumers?
· Can the FDA limit the amount of money spent on prescription drug ads?
· Does the FDA work with drug companies to create prescription drug ads?
· Does the FDA approve ads for prescription drugs before they are seen by the public?
· What must product claim ads tell you?
· What are ads not required to tell you?
· Does the law say anything about the design of ads for prescription drugs?
· Has FDA done research on DTC advertising?
· How can an ad violate the law?
· Who should I tell if I think that a prescription drug ad violates the law?
· What does FDA do if it determines that an ad violates the law?
· What is Off-Label and the consequences with HCP's?
· Why FDA has complete jurisdiction over prescription drug labeling and advertising, as well as all medical device labeling, but has limited jurisdiction over medical device advertising?
Who Will Benefit:
· Management responsible for regulatory and GMP/GLP/GCP compliance and seeking a better understanding of FDA, advertising and promotional requirements, regulatory actions and how they can improve their own firm's operations and monitoring of their state of compliance and meeting requirements
· Individuals who come in contact with regulatory inspectors
· Auditors
· Compliance/Regulatory affairs professionals
· QA/QC professionals
· Senior management executives (CEO, COO, CFO, etc.)
· Manufacturing managers, supervisors & personnel
· Project Managers
· Regulatory Affairs Management
· Regulatory Affairs Specialist
· Compliance Officer
· Compliance Specialist
· Clinical Affairs
· Quality Assurance Management
· Marketing & Sales
· Distributors/Authorized Representatives
· Legal Counsel
· Engineering/Technical Services
· Operations/Manufacturing
· Consultants
· Marketing Communications
· Medical Information and Affairs
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.
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)
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Until August 15, Early Bird Price: $1,295.00
From August 16 to September 02, Regular Price: $1,495.00
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Day 1