Simplifying Global Compliance
The Webinar Training Pass
Now get all the training you need – all in one place, and all for one low price!
The FDAnews Webinar Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs feature top consultants, expert speakers and FDA officials.
PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!
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: 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
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
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
