Commercial Operations

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The 21st Century Cures Act & Regenerative Medicine - Webinar CD/Transcript

$287.00
The biologics license application (BLA) is perhaps the most burdensome and lengthy premarket review process that the FDA imposes. To address that, Congress created the Regenerative Advanced Therapy (RAT) designation. View

Conducting an Internal Audit for Pharmaceutical and Medical Device Companies - Webinar CD/Transcript

$101.00
Internal audits are critical element of your quality management system. Your approach must be both systematic and documented to remain compliant. Information from an internal audit provides management with the knowledge they need to show how effectively the company maintains the quality of the product and their processes. View

The Reality of Doing Business in Cuba in 2017 - Webinar CD/Transcript

$287.00
Join Jennifer Diaz — a board certified international attorney — as she discusses the realities of doing business in Cuba including whether the new Trump administration will continue with efforts to open up Cuba to U.S. business or if we will see a return to the more closed and distant relationship of the past. View

Off-Label Drug Promotion - Webinar CD/Transcript

$287.00
The FDA allows manufacturers to engage in off-label communications under certain circumstances including: responses to unsolicited requests — through sponsorship of continuing medical education events where off-label uses are discussed — peer-reviewed journal articles — medical texts — and clinical practice guidelines containing off-label information. Join legal expert Alan Minsk — of Arnall Golden Gregory — as he discusses the FDA’s latest rules on what speech is and is not protected. View

Responding to Compounding Pharmacy Inspections - Webinar CD/Transcript

$287.00
The FDA is looking to shed light on the sometimes murky rules governing compounding operations primarily regulated on the state level, only adhering to USP 797 Pharmaceutical Compounding — Sterile Preparations. View

Assessing the Benefit-Risk Balance in Company Core Data Sheets - Webinar CD/Transcript

$287.00
Do you know the new rules — and how to apply them — for your Company Core Data Sheets? Join Graeme Ladds — CEO of PharSafer® — for a discussion on the current guidances and rules including what stayed the same and what changed. If you just rely on your understanding of the guidance that was released four years ago, you’ll be taking a risk and not adhering to the new rules. View

New Trump Administration, New Republican Congress - Webinar CD/Transcript

$287.00
The US has a new president, a new Congress, and almost assuredly a new agenda for the FDA — with different policies and priorities than the current administration. What does this mean for FDA regulated industries? View

False Claims Act Liability: A Guide for Drug and Device Manufacturers

$397.00
The False Claims Act Liability management report explains the basics of FCA liability and highlights areas of regulatory risk for drug and device manufacturers. Use it to build a strategy for avoiding problems and dealing with charges if they do happen. View

Successful Collaboration with Your Sales and Marketing Team - Webinar CD/Transcript

$287.00
Do you need a better working relationship between Regulatory Affair and your sales and marketing teams? Hear directly from an expert who has personally facilitated communication between these two groups. Join Katy Van Pelt — Partner, Potomac Law Group — for a 20-minute presentation, followed by a 30-minute one-on-one interview conducted by moderator Michael Levin-Epstein. View

Reduce Human Error in Drug and Device Manufacturing - Webinar CD/Transcript

$287.00
What causes drug and device manufacturing failures and recalls? Human error. Time after time, CAPA investigations single it out as the root cause of violations. If there were a magic formula for ending human error, we’d share it. But here’s the next best thing — systematic best practices and strategies that have been proven to cut human error and boost success on the factory floor. View

Special Protocol Assessments - Webinar CD/Transcript

$287.00
When should you consider pursuing an SPA? If you do, how long will it take? Join Alexander Varond — Associate at Hyman, Phelps & McNamara — for an overview of the SPA program and a discussion of the impact of the FDA’s new draft guidance on sponsors and regulatory affairs professionals, and key opportunities and challenges for sponsors. View

False Claims Act Liability for Regulatory Noncompliance - Webinar CD/Transcript

$287.00
The Department of Justice’s interim final rule virtually doubles penalities for those that violate the False Claims Act. How can you avoid liability under the FCA? Join Anna Laakmann — Counsel, Greenberg Traurig — explains how regulatory noncompliance can form the basis of an FCA enforcement action by the government. View