Trial Design

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ICH E6 R2 - Webinar Recording/Transcript

$287.00
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

Managing FDA GCP/Bioresearch Monitoring Inspections - Webinar Recording/Transcript

$287.00
Clinical trial principal investigators and sponsors have their very own dedicated team of FDA inspectors, the Bioresearch Monitoring (BIMO) program staff. Washington public policy lawyer, David Rosen, has made a study of their inspection practices. View

The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium

$397.00
The 21st Century Take on Observational Studies walks you through everything you need to know about the opportunities and pitfalls observational studies can offer. The report looks at the growing trend toward observational research and how provisions in the 21st Century Cures Act create even more incentives to rely on real-world evidence in the development of medical products. View

Expanded Access at a Crossroads - Webinar Recording/Transcript

$287.00
Expanded Access is the hottest topic in new-drug development, and now the FDA appears ready to loosen the reins. View

Tools for Faster Drug and Device Development: FDA’s New Pathways to Innovation

$397.00
In Tools for Faster Drug and Device Development: FDA’s New Pathways to Innovation noted FDA law expert Jim O’Reilly lays out the current landscape of drug and device development tool research. He explains how the 21st Century Cures Act has established an updated, multi-stage process for development tool qualification and explores how the FDA will implement it. View

Informed Consent for Clinical Trials 2017: A Regulatory Reference Guide

$377.00
FDAnews’ new edition of Informed Consent for Clinical Trials helps you understand all the changes that are coming and gives you all the resources you need to comply with informed consent rules — all in one place. View

ClinicalTrials.gov: Mastering New Reporting Rules

$397.00
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

Global Regulation Under Gottlieb-Trump and a Look Ahead - Webinar Recording/Transcript

$287.00
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

$287.00
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

$287.00
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

$287.00
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

Promotional Communication: Keeping Up with FDA’s Off-Label Use Policy

$397.00
Promotional Communication: Keeping Up with FDA’s Off-Label Use Policy explores the draft guidances and other FDA activity on the subject of promotional communication — explaining what companies must do to stay on the right side of the agency’s new policies and how to take advantage of the opportunities they present. View