Regulatory Affairs & Compliance Consultant David R. Dills Explores ` Advertising and Promotional Requirements for Drugs and Medical Devices` at San Diego 2014

Topics

• Does the FDA review and approve all advertisements for drugs before their release?
• Does the FDA control advertisements for all drugs?
• Does the FDA require drug companies to use hard-to-understand medical language in ads directed to consumers?
• Does Federal law ban ads for drugs that have serious risks?
• Does the FDA work with drug companies to create prescription drug ads?
• Can the FDA limit the amount of money spent on prescription drug ads?
• What must product claim ads tell you?
• Does the FDA approve ads for prescription drugs before they are seen by the public?
• Does the law say anything about the design of ads for prescription drugs?
• What are ads not required to tell you?
• How can an ad violate the law?
• Has FDA done research on DTC advertising?
• What does FDA do if it determines that an ad violates the law?
• Who should I tell if I think that a prescription drug ad violates the law?
• 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?
• What is Off-Label and the consequences with HCP`s?

Who should Attend

• Individuals who come in contact with regulatory inspectors
• 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
• Compliance/Regulatory affairs professionals
• Auditors
• Senior management executives (CEO, COO, CFO, etc.)
• QA/QC professionals
• Project Managers
• Manufacturing managers, supervisors & personnel
• Regulatory Affairs Specialist
• Regulatory Affairs Management
• Compliance Specialist
• Compliance Officer
• Quality Assurance Management
• Clinical Affairs
• Distributors/Authorized Representatives
• Marketing & Sales
• Engineering/Technical Services
• Legal Counsel
• Consultants
• Operations/Manufacturing
• Medical Information and Affairs
• Marketing Communications