Commercial Operations

ARTICLES

PRODUCTS

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

The Most Important Legal Cases Regulatory Affairs Specialists Absolutely Must Understand - Webinar CD/Transcript

$287.00
Legal expert William Janssen — Professor of Law, Charleston Law School — provides a practical explaination of recent key decisions that affect what regulatory affairs does every day, in ways you may not have realized before.  View

OTC Labeling and Advertising - Webinar CD/Transcript

$287.00
What are the most significant new developments that marketers of OTC drugs face? Stacey Erhlich and Will Woodlee — Partners at Kleinfed, Kaplan & Becker, LLC — discuss what OTC drug products require premarket approval, labeling and promotion rules, and common but avoidable mistakes in marketing OTC drug products. View

Correcting Misinformation in Social Media - Webinar CD/Transcript

$287.00
It’s happened again. A social media post. And it’s inaccurate. And someone — a customer perhaps — is sure to believe it. What can you do — other than grind your teeth in frustration? View