Postmarket Safety

ARTICLES

PRODUCTS

Off-Label Drug Promotion - Webinar CD/Transcript

$187.00
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

Inspection Intelligence: Develop a Data–Driven Approach - Webinar CD/Transcript

$287.00
To be inspection ready you must understand both the internal and external data affecting your products — and analyze and act on the data. Expert Armin Torres — Principal Software Consultant at Qualified Data Systems — discusses how to make sure that your data — which has come from multiple sources — is internally consistent across the full data set and with your company metrics and KPIs. View

20 Elements of Postmarket Reporting: Building Periodic Benefit-Risk Evaluation Reports

$177.00
With the 20 Elements of Postmarket Reporting brief you will learn how to prepare Periodic Benefit-Risk Evaluation Reports (PBRER) in a modular format that can be used in other postmarket surveillance reports required by the FDA and international regulators. 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

Top Ten Data Integrity Traps: How to Find and Fix Problems

$177.00
The Top Ten Data Integrity Traps report shows you where most data integrity problems occur and helps you create a plan to weed them out — and keep them out. View

Inspections — From the Routine to the Truly Bizarre - Webinar CD/Transcript

$287.00
As you are well aware, even a routine FDA inspection can be problematic — challenging — or truly bizarre. Be prepared to deal with the challenging inspection situations that an FDA inspector may throw your way. View

Managing Contract Manufacturers and Testing Labs

$397.00
Are your contract manufacturers getting you in trouble? Problems with a contract manufacturer or lab can emerge in dozens of unexpected places. From changes in personnel or equipment to faulty SOPs and training, the list can seem impossible to tame. 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

Training Staff to Detect Data Integrity Issues - Webinar CD/Transcript

$287.00
Over the past few years, global regulators have increased their focus on data integrity systems. Who is responsible for data integrity? Find out in this 90-minute presentation. View