Regulatory Affairs

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What pharma regulatory issue will have the greatest impact on you in 2020? This presentation is your crystal ball into how the key regulatory and related issues affecting pharmaceutical quality, regulatory and compliance specialists will be addressed by the FDA in 2020. View

Your connected technology — the integration of your electronic document management, training management, risk mitigation, risk management, deviation and CAPA management, and audit management systems — will trigger the kinds of checks and balances across systems that increase compliance and reduce risk. View

How should you prepare for your next inspection? The answer, hiding in plain sight, lies in the analysis of recent FDA enforcement trends. And who better to guide you than top Washington FDA lawyers Chalana Damron Esq. and John Fuson Esq. of Crowell & Moring LLP. View

Human Error Solutions’ CEO, Ginette Collazo, Ph.D. — an industrial-organizational psychologist and one of the world’s few human error reduction experts — will explain how to write and get SOPs that minimize human error. View

What implications does the recent Instructions for Use (IFU) guidance have on your new drug applications and biologics license applications? Alan G. Minsk, Esq. — a partner and leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP — will clarify the new guidance and explain how to comply with it. View

Mark Levy, Esq. — a litigator and trial attorney who is an expert in defending companies in alleged criminal and civil violations of the False Claims Act and the Food, Drug and Cosmetic Act — is here to share his knowledge of compliance regarding off-label marketing with you. View

Is IT a fully vested member of your data integrity team?  The success of your next inspection could depend on it. But many firms — yours among them, perhaps — haven’t fully brought the IT folks onto the team. Now comes FDAnews with an all-new webinar to help solve this problem ... before the inspectors’ next visit. View

It’s been seven years since FDASIA was enacted and the path to globalized GMP inspections of drugmakers is complete at last. The Mutual Recognition Agreement (MRA) provides for inspection cooperation among the FDA and the 28 member nations of the EU. What happens now??? View

Do you do business in China? With the fluidity — and uncertainty — of today’s regulatory environment, you must understand exactly what China has implemented, what is pending and what the near future holds. View

As the Drug Supply Chain Security Act’s (DSCSA) key requirements continue to take effect, FDA has begun enforcement. If you must comply with DSCSA’s implementation requirements, this presentation can’t be missed. You’ll be updated on implementation processes to gain a clear understanding of the guidelines’ nuances and tactics to avoid problem areas. View

If you find the FDA’s regulatory framework regarding regenerative medicine and stem cell therapies confusing, you’re not alone. A noted expert is here to explain the current regulatory framework and FDA’s interpretation, enforcement actions not only from FDA but FTC and the states, and opportunities for the legal development and use of stem cells. View

Dr. Mary Jo Lamberti — associate director of sponsored research at the CSDD — and Francis Kendall — senior director at Cytel — will share critical factors you need to consider in using RWE and provide insight into the current and planned uses of RWE to support development and post-approval safety studies. View