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Historically, it has been straightforward for the FDA to review and monitor labeling and advertising for products under their jurisdiction, particularly drugs and medical devices. However, the widespread use of the internet and social media has added increasing complexity to the issue for the agency as well as for FDA-regulated industries. As a result, the FDA issued several guidance documents and, while applicable only to prescription human and animal drugs and medical devices, they should be used to gauge the agency’s current thinking regarding social media and its use for promoting the products they regulate. These guidance documents were released by FDA that describe best practices for use of Twitter-like services, published material, use of web-sites and other public disclosures for sharing marketing and off-label information, and even how to address misinformation at non-company controlled information outlets. In addition, FDA has issued several Warning Letters to manufacturers indicating the rules for using social media. How can medical device, pharmaceutical and other FDA regulated industries use social media outlets like Facebook, Twitter, YouTube, web-sites and other social media tools to get their message out in a way that is compliant with advertising and promotion regulations that are found in the Food Drug & Cosmetic Act? Social media is a powerful tool and fast-evolving information platform. There is no doubt that the FDA, FTC and other regulatory bodies worldwide will further define and clarify their approaches to monitoring and regulating advertising and promotion of products this way. It would therefore be wise for industry to become familiar with current agency expectations and stay abreast of future developments. In addition, companies should have their websites and social media sites reviewed for compliance with FDA regulations to ensure that all of the content is truthful, substantiated, permissible and not misleading. Clearly, social media has changed the way we market drugs, medical devices and other medical products. Companies need to be diligent in setting up internal systems to ensure regulatory compliance and maintain truthfulness in marketing and flexibility in designing social media policies that can change in response to additional guidance and/or regulations.
Areas covered in the session:
• Common ways companies are currently using social media
• Does the manufacturer have a mechanism for tracking websites on which employees and agents post messages or statements about its products?
• Will the manufacturer's policies and procedures for company and employee posting of product-related statements on social media websites need to change in order to comply with FDA's recommended submission methods?
• Will the manufacturer implement internal monitoring or auditing of social media promotions—e.g., by requiring a review of social media activities?
• Trends and recent discussions regarding the FDA’s overview and enforcement of social media as it pertains to marketing regulated products, e.g., medical devices
• Risks and benefits: FDA guidance documents regarding the distribution of information via social media
• FDA advertising and promotion issues related to social media
• Your responsibility for promotion and advertising in social media
• Companies should consider prohibiting discussion groups on their own websites and forums if they are not able to rapidly screen comments before approving their posting
• Recent trends in FDA enforcement actions involving social media
• Increasing enforcement by FDA
• Common complaints
• Establishing internal procedures for off-label marketing is a must and should include information on how to use social media forums
• Risks with social media as a recruitment tool
• Do’s and Don’ts of using social media in recruitment strategy
Who will benefit:
This webinar will provide valuable assistance and guidance to medical device, pharmaceutical and other life sciences manufacturers responsible for the quality and security of their raw materials to support product development and product release activities. The employees who will benefit include:
• All levels of management and departmental representatives
• Regulatory Affairs
• Compliance Management
• Regulatory Vice Presidents, Directors and Managers
• In-house or Outside Legal Counsel
• Senior Management
• Marketing Management
• Sales Vice presidents, Directors and Managers
• Quality Assurance
David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, cosmetics and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 25 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatory audits.
He has been directly involved with constructing, reviewing, and/ or remediating regulatory submissions, including 510(k), PMA, IDE applications, IND, BLA and NDA submissions, preparing Supplements, Amendments, U.S. Agent, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.
Mr. Dills has a strong background in the interpretation and applicability of FDA regulations, including 21 CFR 210/211, 820 QSR/cGMP, Quality System implementation and compliance requirements, GxP training, leads and directs activities for the registration and approval process and working with Agencies in Asia Pacific, EU and The Americas, including but not limited to FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, SFDA, TGA, and Health Canada; and defining and executing regulatory compliance, risk mitigation and remediation strategies in response to inspection findings. Additional activities include Pre-FDA Facility Inspections, Mock Audits/Due diligence and assessing state of readiness for Pre-approval inspection (PAI/PMA), proof of management oversight, facilitate and direct efforts for remediation planning and monitoring, and assessment of the critical sub-systems, records and document controls; and strives for reduction of regulatory compliance risk for companies.
Directs and leads efforts for PM support and consultative services on behalf of manufacturers and subcontracted by third-party consultancies and provides services involving all phases of the product development, submission, and commercialization process from premarketing to postmarketing; retained as U.S. Agent for international pharma and device clients; conducting supplier and QS audits/assessments; establishment registration and listing; Agency inspection readiness preparation and remediation; preparing Agency responses due to enforcement actions; conducting GxP audits and preparing CAP/remediation plans; compliance engineering support; support and/or lead efforts regarding Adverse Event, MDR, Incident Reporting, Postmarketing Surveillance and Vigilance Reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing.
Mr. Dills manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations/commercial opportunities. Develops strategies for governmental approval to introduce new products to market, provides guidance and clarity on regulatory requirements, prepares and/or reviews submissions [e.g., NDA, ANDA, 510(k), PMA, IDE and BLA], including design dossiers and technical files, and other applications for Asia Pacific, The Americas and EU. Directs and leads efforts in establishing and retooling QA systems with emphasis on preventing the design, manufacture, and shipment of defective product; provide compliance engineering support; and lead efforts for GxP Strategic Compliance.
Mr. Dills manages regulatory problems (e.g. AE’s, MDRs, Agency enforcement, and complaints) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; RA/RC oversight and governance; design controls; CAPA/investigations; GxP training; software and process validation with compliance oversight; supplier management; interfaces with FDA and other Agencies on the regulatory landscape; compliance with MDD/IVDD Directives and Technical File/Design Dossier and CE Mark requirements; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure.
He also develops strategies and adds business value to manufacturers by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones and on minimizing delays due to noncompliance. He conducts Compliance Governance Assessments and Agency Mock Inspections; provides assistance during inspections and with post-inspection correspondence and meetings, involved in the product life cycle and commercialization process and works effectively across all functions for overall corporate compliance to support a company’s goals and strategies.
Mr. Dills analyzes the benefits/risks for informed decision-making; interprets the regulatory precedents and new legislation; understands the competitive landscape; develops the business and regulatory approach; conducts persuasive communication with regulatory authorities; executes an effective path to approval; assists with GxP compliance strategies, effectively coordinates development in multiple markets; selects appropriate testing and manufacturing suppliers; and strives for overall corporate compliance with regulations in The Americas, EU, and Asia Pacific.
He provides direction on understanding the regulatory landscape for the product and provides a fully integrated approach to device development including design controls, and effective communications with Regulatory Authorities related to product development and post-marketing activities.
Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals.
Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills’ academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ’s Section 1506 and associated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups
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