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The FDAnews Webinar Training Pass program offers year-round, unrestricted access to any of the hundreds of webinars listed below. These training programs feature thought leadership and best practices from top consultants, expert speakers and current and former FDA officials. New webinars are offered every month, along with access to the Webinar Training Pass archive.
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Webinar Training Pass
Recorded on: Aug. 16, 2018
Description: Three FDA specialists weigh in on Commissioner Scott Gottlieb’s first year in office and his priorities for the future. They discuss:
- What Gottlieb is trying to change and how he’s going about making it happen;
- How the drug and device approval process has changed and how it could change in the future; and
- The commissioner’s strategy for dealing with the opioid crisis.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: John Kamp, Counsel, Coalition for Healthcare Communication; Kevin Madagan, Partner, Reed Smith; and Wayne Pines, President of Health Care, APCO Worldwide
Getting Real About Real-World Evidence
60 minutes
Recorded on: Aug. 15, 2018
Description: FDA specialist Sonali P. Gunawardhana and clinical research expert Mary Jo Lamberti discuss the evolution of real-world evidence (RWE) in clinical studies and the FDA’s policies and priorities. Topics include:
- Ways drugmakers are using RWE to support promotional claims and premarket applications;
- Impact of recent FDA statements on including RWE in approval and clearance applications and as a basis for drug and device promotional claims; and
- How the agency may use RWE to support regulatory decisionmaking.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Sonali P. Gunawardhana, Of Counsel, Shook, Hardy & Bacon LLP, and Mary Jo Lamberti, Professor and Associate Director of Sponsored Research, Tufts Center for the Study of Drug Development
MDR Adverse Event Codes for Devicemakers
84 minutes
Recorded on: Aug. 14, 2018
Description: Device regulatory expert Dan O’Leary explains the FDA’s new MDR coding regimen. He discusses:
- Criteria for a mandatory medical device report;
- Required records and their content;
- The reporting system and associated acknowledgements; and
- The schedule for transitioning to the new system.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Digital Health Tools
87 minutes
Recorded on: Aug. 1, 2018
Description: Regulatory expert Bradley Merrill Thompson outlines how the FDA has regulated digital health products to date and what it plans in months to come. He discusses:
- AI-powered clinical decision support software;
- Postmarket surveillance;
- Cooperation with industry; and
- Premarket digital safety.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Bradley Merrill Thompson, Attorney, Epstein Becker & Green P.C.
European Medical Device Regulations
109 minutes
Recorded on: July 31, 2018
Description: European regulatory expert James Pink provides a deep dive into the new EU MDR. He discusses:
- New requirements for documentation confirmation and updating;
- New separate software rules;
- Stricter requirements for implantable devices; and
- Possible sanctions for devicemakers who are not ready to comply with the new rules.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: James Pink, Vice President, NSF Health Sciences Medical Devices, Europe
Recorded on: July 26, 2018
Description: Attorney Jessica Ringel outlines provisions of the FDA Reauthorization Act of 2017 and their impact on devicemakers. She discusses:
- Changes in user fees for premarket submissions;
- Improvements anticipated in the FDA inspections process;
- How transparency in certificates to foreign governments issuance and denials will increase;
- Specific FDA efforts to stimulate pediatric device innovation; and
- New guidances, rules and reports anticipated from the agency in coming years.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jessica Ringel, Counsel, FDA and Life Sciences Practice, King & Spalding LLP
Recorded on: July 18, 2018
Description: Electronic submissions expert Antoinette Azevedo explains the technical and organization challenges of complying with the FDA’s eCTD specifications:
- How to avoid a refuse-to-receive when submitting your eCTD;
- Strategies for developing a roadmap for implementing the technical and organization components for eCTD success;
- Real world impact of eCTD format on your CMO and CRO partners; and
- The impact of eCTD on submissions to the rest of the world health authorities.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Antoinette Azevedo, President & CEO, e-SubmissionsSolutions.com
Real-World Evidence and the NEST Program
83 minutes
Recorded on: July 17, 2018
Description: FDA official Owen Faris provides a view into FDA’s thinking and activities related to the use of real-world evidence (RWE) and the National Evaluation System for Health Technology (NEST). He discusses:
- Why the FDA is promoting the use of RWE to evaluate medical devices;
- Proof of concept as it applies to using RWE for device evaluation; and
- How RWE and NEST can specifically apply to medical device development.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Owen Faris, Director of the Clinical Trials Program, CDRH
Preparing for the MDSAP Audit Process
83 minutes
Recorded on: July 11, 2018
Description: Regulatory compliance expert Connie Hoy explains the Medical Device Single Audit Process. She discusses:
- Using the companion document as a preparation guide;
- Ensuring your quality system covers specific country requirements;
- Questions auditors are likely to ask; and
- How the process differs from FDA inspections and ISO audits.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Connie Hoy, President, Hoy & Associates Regulatory Consulting
The Real Impact of the Common Rule in 2018
77 minutes
Recorded on: June 21, 2018
Description: Clinical research compliance experts Jennifer Mallory and Carrie Hanger provide an overview of changes in the Common Rule set to take effect in January 2019. They discuss:
- Broad consent for secondary research;
- Limited and continuing IRB review;
- Exemptions;
- Federalwide assurances; and
- Cooperative research.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Jennifer Mallory and Carrie Hanger, partners, Nelson Mullins Riley & Scarborough