Transparency

ARTICLES

ICMJE Lays Out Data Sharing Proposal

The International Committee of Medical Journal Editors is seeking feedback on proposed requirements involving transparency for clinical trials authors as a condition for publication in member journals. Read More

PRODUCTS

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

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

$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

FDA’s Work Plan ... the 21st Century Cures Act ... and You - Webinar CD/Transcript

$287.00
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

$287.00
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

Spreadsheet Validation 2017 - Webinar CD/Transcript

$287.00
What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he highlights potential pitfalls and defines innovative validation approaches ... ask why he does this instead of that ... and get feedback? View

Observational Research - Webinar CD/Transcript

$287.00
The 21st Century Cures Act promises to usher in a new era of drug development by dramatically lowering the cost of clinical trials while speeding the path to market. Noted researcher Jeff Trotter shows you how to take full advantage of the Cures Act and start reducing drug trial costs today. View

ICH E6 GCP Revisions - Webinar CD/Transcript

$287.00
Every clinical trial operator will feel the impact of the major revision of the ICH E6. The revision, known as ICH E6 (R2) GCP, will impose new requirements to use state-of-the-art technology ... force changes in trial design, conduct, oversight, recording and reporting ... and all the while, continue insisting on highest standards of human protection and data integrity. View