Inspections and Audits

ARTICLES

Report Outlines Strategies for Risk-Based Monitoring

As centralized risk-based clinical trial monitoring becomes the norm, sponsors are gaining access to broad overview data on research and compliance trends that can help them identify both real and potential problems across their trial locations. Read More

Trial Investigator Warned Over Lack of SOP Documentation

A San Diego, Calif.-based clinical researcher received an FDA warning letter over its lack of documentation of standard operating procedures for overseeing studies and details of in-service protocol and specimen handling training in a Form 483 response. Read More

FDA Reduces Clinical Hold On Tekmira’s Ebola Drug

Canadian biotech company Tekmira is set to restart a Phase I trial of its TKM-Ebola RNA interference therapy in the coming weeks, after the FDA downgraded a partial clinical hold that allows the company to administer repeat doses not greater than 0.24 mg/kg/day. Read More

Expert: Clearly Define Roles Of the Central IRB

Clinical trial sites should determine their compatibility with central institutional review boards, including whether software they use to interface with the local IRB is capable of handling an outside review board, an expert says. Read More

PRODUCTS

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

Internal Auditing Basics: A Guide for Drug and Device Manufacturers

$177.00
Internal Auditing Basics: A Guide for Drug and Device Manufacturers demonstrates how to build an auditing operation, including scheduling and reporting, explains regulatory requirements and discusses how to turn audit results into positive improvements. 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

The FDA Under a New Commissioner - Webinar CD/Transcript

$287.00
Likely new FDA Commissioner Scott Gottlieb is an old agency hand thrust into a new role. Will he toe the Trump line ... or show independence? Is his past a guide ... or will he strike out in new directions? Will he ease new drug and device approvals ... or toughen them? Increase inspections ... or ease off? More 483s and warning letters ... or fewer? View

Clinical Research Manual

$380.00
Clinical Research Manual brings together guidance on everything from pharmacokinetics and study design, to recruitment, monitoring, statistics… all the problem compliance areas you need to stay on top of to conduct clinical trials that will stand up to regulatory scrutiny. View

Medical Device Clinical Evaluation Reports - Webinar CD/Transcript

$287.00
Michelle McDonough — Associate Director, Regulatory and Clinical Affairs, MCRA — discusses the requirements for CERs and their place in supporting new device certification and maintaining certification. She will cover best practices for completing CERs, complying with regulations including the MEDDEV 27/1 Rev 4 guidance. View

Combination Products and Cross-Center Reviews - Webinar CD/Transcript

$287.00
Mapping out a regulatory pathway for drug/device/biologic combination products remains one of the most difficult regulatory challenges for life sciences innovators. Join David M. Fox — Partner, Hogan Lovells — for a close look at the FDA’s new authority governing combination products and several new provisions under the 21st Century Cures Act that could usher in a new era of interdisciplinary product reviews at the FDA. View

Clinical Trial Compliance Guide: FDA Requirements

$397.00
The FDA has issued more than 100 guidance documents relating to clinical trials covering topics from the Animal Rule to validating software used in studies. If you had to pull all of them together yourself — and get the right version — it would take you hours. View

Risk-Based Monitoring of Clinical Trials 2017: New Trends and Best Practices

$397.00
The new FDAnews management report Risk-Based Monitoring of Clinical Trials 2017: New Trends and Best Practices will show you, step-by-step, how to properly design and implement your risk-based clinical trial monitoring program to fully satisfy the FDA’s requirements. View

Using Risk-Based Clinical Trials Monitoring to Improve Data Quality - Webinar CD/Transcript

$287.00
Are you ready to transform your clinical development through advances in RBM? Join Alan Frederickson and Crona O’Conallain — both of QuintilesIMS — while they share recent research showing how RBM increases study quality and patient safety. View