Errors in GCPs – Preventing Nightmares: How Proper Institution of GCPs Principles Ensures Meeting of FDA Regulations

Date: Sunday, Oct. 12 Time: 8:00 am – 12 noon Location: The Alexis Park Resort Hotel, 375 East Harmon Avenue, Las Vegas, NV Advanced Registration Deadline: Sept. 30 Online Registration Deadline (with $150 late fee): Oct. 7 Contact Hours: 3 Member Price: $299 Non-Member Price: $449 Hotel Information Call (800) 582-2228 for hotel reservations, mention attending ACRP 2008 Workshop Weekend, and get a discounted hotel rate of $129/night. These rooms are available on a first-come first-served basis. Discounted rates are not available after September 15. If you don't want to register online, please use this printable registration form.

Companies consistently do not apply adequate GCPs. This is seen in Warning Letters and Integrity Policy Holds. Areas of concern continue to include inadequacy in monitoring, securing Investigator compliance, investigational product accountability, training, and IRB oversight.

This workshop provides practical examples on better ways to meet GCPs and product approvals.

Learning Objectives

Upon completion of this program, attendees should be able to:

• Ensure investigational sites are better prepared for GCP inspection by having learned areas of inadequate GCPs that are consistently noted within Warning Letters.
  
  
• Describe what the FDA GCP expectations are for both drugs and devices.
  
  
• Recognize their company’s responsibilities as it applies to the conduct of GCPs and apply basic concepts to assess whether their company follows GCPs as learned through review of previous Integrity Policy Holds and FDA Warning Letter review.

Trainers

Lee Truax-Bellows, MS, RN, FNP, CCRA, is a Nurse Practitioner with experience in the pharmaceutical and medical device industries, having worked for both industry and a CRO.  She is a founder, President, and CEO of Norwich Clinical Research Associates Ltd.  She has been involved in regulated research for the past 17 years and specializes in product development, GCP auditing and training on US regulations and Good Clinical Practice.  She sits on the ACRP Device Forum Steering Committee.  She is an ACRP Certified CRA and a Society of Quality Assurance Registered Quality Assurance Professional in GCPs.  She is also a member of SoCRA and SQA.

Lee Truax-Bellows, MS, RN, FNP, CCRA reports that she has no commercial interests to disclose relative to the content of this activity.

Jerri B. Perkins, MD, spent eight years at FDA as a medical officer and was an Acting Division Director for medical devices, involved in policy decisions in the Office of the Commissioner and a Reviewing Medical Officer for drugs.  She made recommendations on whether or not devices and drugs were safe and effective for the US market and also advised the FDA Commissioner on how unsafe products should be recalled from the market.

In 1984, she established Perkins & Perkins, Inc, PPI, a medical and regulatory consulting firm. PPI is an independent consulting firm, assisting both pharmaceutical and medical device industries with regulatory and clinical trials quality assurance (GCP).  Dr. Perkins has conducted pre-FDA audit inspections in the U.S. and Europe.  Her audit reports have been used successfully to prepare sites for FDA inspections.

Published articles include basic research topics as well as those regarding FDA issues.  She has given numerous presentations in the USA and Europe, and was invited to speak in China.

Dr. Perkins did her post-doctoral research at the National Institutes of Health in Bethesda, MD and received her medical degree from the Medical College of Virginia.

Jerri B. Perkins, MD reports that she has no commercial interests to disclose relative to the content of this activity.

Accreditation Council on Continuing Medical Education The Association of Clinical Research Professionals (ACRP) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The ACRP designates this educational activity for a maximum of 3.0 AMA PRA Category 1 credits.™ Each physician should only claim credit commensurate with the extent of their participation in the activity.  (Program Number 0007229-08-CME-121) Association of Clinical Research Professionals The Association of Clinical Research Professionals (ACRP) provides 3.0 continuing education credits for the completion of this educational activity with the completion of the evaluation form.  Only claim those credits that are actually earned. These credits can be used to meet the certification maintenance requirement. (Program Number ACRP-2008-ACE-121) Continuing Pharmacy Education The Association of Clinical Research Professionals is accredited by the Accreditation Council on Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Program Number 234-000-08-103-L04-P has been assigned to this program. This program provides 3.0 contact hours of continuing education credit. A statement of credit will be available upon completion of the workshop. Each participant must submit a completed evaluation form at the end of the program to receive a Continuing Education Statement of credit. Partial credit will not be awarded. Release date: 10/12/2008. Continuing Nursing Education The California Board of Registered Nursing approves the Association of Clinical Research Professionals (ACRP) as a provider of continuing nursing education. This workshop provides 3.0 contact hours of continuing nursing education credit (Program Number 11147-2008-ACE-103).