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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Speaker: James Pink, Vice President, NSF Health Sciences Medical Devices, Europe