2-day In-person Seminar on “Advertising and Promotional Requirements for Drugs and Medical Devices” in Chicago

Gain a better understanding of how the regulatory and legal environment has evolved and affects the marketing and promotion of pharmaceuticals

Medical & Health Care, Pharmaceuticals/Drug Discovery

2-day In-person Seminar on “Advertising and Promotional Requirements for Drugs and Medical Devices” in Chicago 4-5 Sep 2014 Courtyard Chicago O'Hare, Des Plaines, United States
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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.

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

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.