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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If you are already a Training Pass member, login below and then scroll down to view the list in date order or narrow your search by keyword or category. Viewing the webinar is easy… simply identify the webinar you want to watch, click on the title and the video will begin. If you would like to view or download the presentation materials separately from the video, click the "Download Presentation" link.
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Webinar Training Pass
Recorded on: Sept. 17, 2018
Description: Regulatory experts August Horvath and Mark Mansour discuss the variety of federal, state and local authorities keeping an eye on drug and medical device promotion. They cover:
- What to expect from the FDA, FTC, state attorneys general, the Better Business Bureau and others;
- Trigger points for enforcement for each agency;
- How to avoid legal liability; and
- Top tips for remedying enforcement problems.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: August T. Horvath and Mark Mansour, Partners, Foley Hoag LLP
Recorded on: Sept. 12, 2018
Description: Quality management expert Steve McCarthy explains the benefits of leveraging data to improve systems. He discusses:
- The companywide benefits of data-driven quality management;
- Identifying and influencing key stakeholders across the value chain; and
- Creating a foundation for complete, accurate and actionable data.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Steve McCarthy, VP of Digital Innovation, Sparta Systems
Recorded on: Sept. 12, 2018
Description: Supply chain management expert Richard Sena discusses how to use supplier quality metrics to evaluate performance. He covers:
- Acceptance percentage v. process yield;
- Training recordkeeping and analysis for self and suppliers;
- Audit preparation and post-audit efficiency; and
- Recall effectiveness measures within the distribution process.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Richard A. Sena, Managing Director, Vaquero Canyon Advisors LLC
Recorded on: Aug. 23, 2018
Description: A panel of clinical trial experts discusses the implications and opportunities presented by the developing field of gene therapy. They talk about:
- How genetic testing is being used in clinical trials;
- How precision medicine is making trial protocols more complicated; and
- Expertise and infrastructure needed to collect genetic information.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Lindsay McNair, Chief Medical Officer, WIRB-Copernicus Group; Jill Johnston, President, Site Support & Management for Clinical Services, WCG; Karmen Trzupek, Director of Clinical Trial Services and Director of Ocular and Rare Disease Programs, InformedDNA
Recorded on: Aug. 22, 2018
Description: Attorneys Mark Levy and Elizabeth Abrams discuss potential criminal and civil liabilities drug and device manufacturers often face and how to handle them. They cover:
- Justice Deptartment policy on compliance programs, a process that has direct impact on regulatory and quality professionals;
- Enforcement of the FDCA and the False Claims Act and the impact of whistleblowers; and
- Strategies for avoiding both criminal and civil liability.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Mark Levy, Partner, Eckert Seamans Cherin & Mellott; and Elizabeth Abrams, Assistant U.S. Attorney for the Eastern District of Pennsylvania, Criminal Division
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
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
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
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.
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