Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Editor's Picks
Lumendi Receives 510(k) Clearance for Endoscopic Accessory
The device also assists with optical visualization, endoscopic treatment and diagnosis, and has two balloons that create a stabilizing therapeutic zone inside the colon.
HHS Issues Grants Totaling $485 Million to Fight Opioid Crisis
The Substance Abuse and Mental Health Services Administration is expected to issue a further $1 billion in grant funding in September.
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Top Tips for Dealing with the FDA - Webinar Recording/Transcript
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The FDA is an inescapable presence in your life. It can be supportive and helpful one day, then turn on a dime and make life quite difficult indeed. But you have a say in the matter. You can control this all-important relationship to your advantage. View
Lean Management to Improve Quality & Compliance - Webinar CD/Transcript
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“Lean management” has come to the drug and device world, improving quality, ensuring compliance and boosting profits for those who adapt its ways to the production floor. If you’re not among them yet, then listen up. View
Sensors and Wearables in Clinical Trials - Webinar Recording/Transcript
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There’s a transformation going on in the clinical trials world. It’s called mobile health (“mHealth”), and it entails use of smartphones, sensors and wearables to monitor trial subjects in ways not previously possible. View
ICH E6 R2 - Webinar Recording/Transcript
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The ICH E6 R2 GCP guideline has major impact on everyone from clinical trial principal investigators to drug and biologics makers. But a year after its promulgation, clinical trials professionals still struggle with its provisions. View
Clinical Trials Adverse Event Reporting Guide, 2017 Edition
$397.00
You’ll find the answers to those questions and many more in the 2017 edition of Clinical Trials Adverse Event Reporting Guide. View
ClinicalTrials.gov: Mastering New Reporting Rules
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ClinicalTrials.gov: Mastering New Reporting Rules parses out the rules provisions, explaining who must report what — what information they must submit — what deadlines are — and what could happen if they miss the mark. View
The FDA Under Gottlieb-Trump and a Look Ahead - Webinar Recording/Transcript
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In Part IV of FDAnews’s Expert Insight Series, our panelists look overseas to evaluate drug and device regulation globally, and venture educated guesses concerning the direction of drug and device regulation in 2018 and beyond. View
Pharmaceutical Regulation Under Gottlieb-Trump - Webinar Recording/Transcript
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In Part III of FDAnews’s Expert Insight Series, our panel takes up drug regulation, policy and enforcement. View
Device Regulation Under Gottlieb & Trump - Webinar Recording/Transcript
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In Part II of FDAnews’s Expert Insight Series, our panel dives deep into device regulation, policy and enforcement. View
What We’ve Learned Since Scott Gottlieb Was Confirmed - Webinar Recording/Transcript
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FDAnews has assembled a standout panel — five top experts, four of them ex-FDAers — to bring their insights to bear on how the Gottlieb FDA will impact your products and programs. View
FDA’s Work Plan ... the 21st Century Cures Act ... and You - Webinar CD/Transcript
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The 21st Century Cures Act is a mega-complex set of compromises that Congress mandated. Right now, behind closed doors, the FDA is figuring out how to implement it. Every FDA-regulated health sciences company will be affected. View
ClinicalTrials.gov and the New Final Rule (42 CFR Part 11) - Webinar CD/Transcript
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After reading and re-reading the 177 pages of 42 CFR Part 11, “Final Rule for Clinical Trials Registration and Results Information,” many trial operators are scratching their heads. Scott Cunningham Esq., translates the knottiest provisions of the final regulation into simple English. View