ComplianceOnline

Presenting Risk Information in Drug and Medical Device Promotion: FDA's Update on Draft Guidance for Industry

Instructor: David Dills
Product ID: 701537
Training Level: Basic to Intermediate
  • Duration: 60 Min

recorded version

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Read Frequently Asked Questions

This FDA's Update on Draft Guidance webinar will provide an overview to companies who need to learn how FDA evaluates risk communication in promotional materials and what factors are considered for Drug and Device Promotion.

Why Should You Attend:
This draft guidance titles “Presenting Risk Information in Prescription Drug and Medical Device Promotion” (“Draft Guidance”). describes factors FDA considers when evaluating advertisements (ads) and promotional labeling for prescription drugs, ads for restricted medical devices, and promotional labeling for all medical devices for their compliance with the Federal Food, Drug, and Cosmetic Act (the FD&C 21 Act or the Act) and relevant regulations. This guidance responds to stakeholder requests for specific guidance on how FDA evaluates prescription drug and medical device promotional pieces, but does not address over-the-counter (OTC) drug promotional labeling, which FDA also regulates. Where as omission or minimization of risk information to healthcare professionals and consumers is the most frequent violation of the regulations cited in advertising/promotion enforcement letters sent to sponsors.

This webinar will provide valuable assistance and guidance to companies who need to better understand what factors FDA intends to consider when evaluating risk information for advertisements and promotional labeling of prescription drugs and medical devices. We will discuss the factors, relevant to the disclosure of risk information and provides numerous examples to illustrate FDA’s thinking on these factors.

Areas Covered in the seminar:

  • Learn what factors are considered in the review of risk communication.
  • Understand what important factors relate to both the content and the format of a promotional piece.
  • How FDA evaluates risk communication in a "promo" piece.
  • Understand and relate to the additional considerations of content and expectations.
  • What is SUPER and the impact on risk disclosure?
  • Learn why this is a draft guidance that will minimize risk of disseminating false or misleading information.
  • Understand why manufacturers should focus not just on individual claims/presentations, but on the messages conveyed by the promotional piece as a whole.
  • Guidance was issued in May 2009 but does provide a better understanding of what FDA expects to mitigate your compliance exposure.

Who will benefit:

  • All end-users from appropriate departments who desire or require a better understanding or a refresh of FDA's expectations relating to the presentation of risk information in product promotion.
  • QA and Compliance
  • Regulatory Affairs Management and RA Specialists
  • Marketing
  • Consultants
  • Technical Writers and employees who review labeling/promotional materials

Instructor Profile:
David R. Dills, Indpendent Regulatory & Compliance Consultant, departed PAREXEL Consulting in July 2008 due to service line organizational change. Prior to joining the consultancy Mr. Dills has provided independent consultative services in various capacities from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance arena to pharmaceutical, Class I/II/III medical devices, in vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems. Through his work, Mr. Dills has been affiliated within the life sciences industry for more than nineteen years with increasing responsibilities in QA/Quality Systems, Regulatory Affairs/Compliance, and Corporate/Operations Management and previously employed on behalf of globally recognized device manufacturers and service providers.

Key areas of focus include product development and commercialization strategies, regulatory classifications, applications and submissions, regulatory and clinical consulting, rapid regulatory crisis response, involved in consent decree/CIA activities, improve and remediate quality management systems and documentation, inspection readiness preparedness for manufacturers and serves in an Expert Witness capacity for a third party. Mr. Dills has prepared and executed effective paths to obtaining approvals, worked effectively across functions for overall corporate compliance, and aligned GxP compliance in a fashion that supports a company’s business strategies and goals.

Key areas of focus also include product development and commercialization strategies, regulatory classifications, applications and submissions, rapid regulatory crisis response, and inspection readiness preparedness for manufacturers. He adds business value to device companies by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones. The focus is on planning, implementation, and training for all phases of the regulatory review and approval process, and on minimizing delays due to regulatory noncompliance.

He has a proven track record and an accomplished regulatory professional working not only with several Notified Bodies and FDA/CDRH/ODE representatives but also international regulatory bodies in Japan, EU, Australia, Canada and other locales. He has worked on and currently working on several J-STED files and Ninsho Certification, IDEs, PMAs and 510(k) submissions and applications, as well as serving on teams related to clinical trials development and deploying sustainable and proven strategies.

Mr. Dills areas of interest and expertise include executing process validation, supplier qualification, training, internal/due diligence audits, policy/procedure development, PM, risk management/assessment, ISO 9001/13485/14971, MDD 93/42/EEC, CE Marking, remediation, GxPs, SW Validation/IT Network, MDR/AE/product complaints, design/change control, CAPA, PMA, IDE, 510(k), NDA and e-CTD/CMCs submissions, interfacing with international regulatory bodies, QSIT and PAI Inspections, product registration, J-STED/Ninsho activities, and training.

Mr. Dills currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and 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. He serves 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 currently serves as Advisor for the ASQ’s Section 1506 and as a former Chair and Co-Chair and is an active member of the Biomedical Division, RAPS, PDA, ISPE, and other industry working groups.

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