Live Seminar: Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices by David R. Dills
August 7 - 8, 2014 - San Diego CA USGlobalCompliancePanel
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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. Who Will Benefit: This seminar will provide an overview and in-depth snapshot of the key principles and requirements for advertising and promotion expectations and ensuring compliance success. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the advertising and promotional requirements for drugs and medical devices, including: • 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 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.