Thursday, August 19, 2010

The ABCs of GCP: What Everyone on Your Team Should Know About Clinical Compliance in the Real World

How can you provide a firm foundation for your newer team members so that they know, and are following, GCP requirements?

Have them all attend this 90 minute webinar. Former FDA BiMo investigator Carl Anderson will go beyond the text of GCP regulations-he will show what inspectors look for in noncompliance, and explain how new and experienced clinical staff should integrate GCP compliance into their daily activities.

After this program, you will know:

The basics of FDA regulatory requirements, starting with the Food, Drug, & Cosmetic Act and including the Code of Federal Regulations, important guidance documents and the International Conference on Harmonization.
How FDA determines responsibility in a clinical trial
What is the Form FDA 1572, Statement of the Investigator, and how has FDA issued new guidance and recommendations- along with new enforcement
The documents that should be in a Trial Master File, at what location, and best practices for record-keeping
The correct way to obtain and document informed consent, and the data FDA will look for in an inspection
What is an adverse event or serious adverse event and is this an "unanticipated problem? What are the reporting requirements?
What, when, and how you should be communicating with IRBs
What is the relationship between the sponsor, the CRO, and the investigator
Warning signs that you may be out of compliance, and who at your company to involve to help fix it
The four biggest misconceptions about GCP, and how to fix them

Carl will also answer your team's questions in the Q&A session.

Who should attend...

Anyone needing a refresher on FDA clinical trial regulation
Professionals new to the industry
Clinical research associates
Clinical trial managers
Principal investigators
Regulatory and clinical affairs staff
Auditors, monitors, and documentation professionals

For one low price, you and your entire team from one location can take part in this fast-paced, insightful webinar. Best of all, you'll be able to connect personally with our panelists when we open up the phone lines for live Q & A.

SPEAKER

Carl A. Anderson
Regulatory Compliance Consultant
Carl A. Anderson, LLC

Carl Anderson is a Regulatory Compliance Consultant. He focuses on regulatory affairs and quality assurance consulting in FDA product approvals including drugs, biologics, and medical devices.

From 1987 to 2005 Carl served with the FDA, first in the San Francisco District Public Affairs office and then in the district laboratory. In 1994 he began conducting inspections in the Bioresearch Monitoring program and inspected clinical investigators, institutional review boards, nonclinical laboratories, and sponsors of clinical research. In 2000 he transferred to the Seattle District, continuing in the Bioresearch Monitoring Program.

Anderson's experience also includes postmarketing surveillance of adverse drug experiences and good manufacturing practice of drug products. He was on the FDA's international inspection cadre and has conducted audits and inspections in Canada, Europe, the Middle East, and East Asia.

Carl has made frequent public presentations on good clinical practice, quality assurance, and FDA regulations to professional and industry organizations including the Society of Quality Assurance, Drug Information Association, Regulatory Affairs Professional Society, and Association for Clinical Research Professionals. He also conducts training for private industry as well as public agencies such as the CDC and university extension services.

Webinar Details

DATE: Thursday, August 19, 2010
TIME: 1:00 PM ET • 11:00 AM MT • 10:00 AM PT
DURATION: 90 Minutes

Benefits

What does registration get me?

One (1) phone line, for you alone, or around which to gather your team(s). Toll-free in the U.S. only.
One (1) password to a website on which you'll be taken through the presenters' slides as they speak to them.
An interactive Q&A round with speakers by phone and electronic submission.
The insight you've come to expect and respect from Elsevier Business Intelligence and our guest speakers.

What are the unique benefits of a webinar?

Convenience—and lower cost. Your entire team can listen in one room. No travel required!
A team approach. You've often wanted to have everyone on your team getting the same knowledge and insight you derive from physical conferences. Now you can.
Interactivity. You're remote, but not removed. Our webinars let you ask the important, burning, controversial questions of our speakers that you'd be able to pose at a physical conference.
Flexibility. Want to be able to review what you learn? No problem ... just register for the live webinar PLUS a digital copy of the entire event to listen to at your convenience. Interested in the topic but have a scheduling conflict? Don't worry — the recording is available for purchase at any time

SUPPORTING PUBLICATIONS

REGISTRATION

Buy the recording/transcript: Click here for just the recorded webinar with the complete transcript, $349
Register by email: custcare@elsevier.com
Register by phone: +1 (800) 332-2181 (U.S.) / +1 (908) 547-2159 (non- U.S.)

Webinar Cancellation Policy: No refunds or credits will be given one week prior to the scheduled webinar, or after the webinar presentation materials and access instructions have been sent to participants. In lieu of cancellation, you may substitute another delegate from your company as a replacement.