When does GCP Non-compliance at an investigator site compromise a regulatory submission? To File Or Not To File - that is the question!

Why Should You Attend:

GCP Non-compliance at the investigator site remains the sponsor’s primary liability for the rejection of the regulatory application. Fifty percent of all FDA study related investigational site inspections incur some level of GCP noncompliance observations. Most of these GCP non-compliance observations do not result in a rejection of the sponsor regulatory application. Sponsors must be able to make this assessment.

While risk management is a sponsor multi- functional process that begins before the study site is set; there is a single sponsor decision that exposes the sponsor to regulatory consequences beyond simply filing the study data in a regulatory application. The determination of GCP compliance, or the significance of any noted investigator non-compliance, should guide the decision to file the efficacy study data in a regulatory application, or not.

This webinar will include a discussion of two real case studies with significant GCP non-compliance where sponsor regulatory, clinical, and ultimately management decisions were associated with two very different outcomes. One of these companies was the subject of a regulatory agency enforcement action and closed down. The other company successfully brought the study product through an approved NDA.

Areas Covered in the Seminar:

• How to confirm and enable the CQA conclusions.
• Which of the 7 GCP compliance objectives directly compromise data integrity?
• Which of the 7 GCP compliance objectives impact acceptability of the submission regardless of the integrity of the study data?
• How the management decision process determined the outcome in these cases.
• How to identify the risk factors associated with filing this data in a regulatory submission in terms.
• of identification of the specific risks,
• of evaluation of the liability of incurring those risks,
• and of exposure to those risks.
• How to determine the cost for NOT submitting the data.
• How to assure that the perspectives of investigator, the sponsor, and the regulatory agency are all part of the final decision.
• The role of the sponsor in causing the GCP non-compliance for each of the cases.
• What sponsor risk management process applied proactively could have avoided this non-compliance?
• What functions should be represented on the core team.
• Which function makes the final file/no file decision?
• Does management really want to know the bad news?
• How the risks associated with filing the data compromised by the GCP non Compliance may vary from FDA, MHRA, EMA, and SFDA.
• If success is the best teacher- what worked and what did not work for these two companies.

Who Will Benefit:

• CQA Managers
• Clinical Research Managers
• Project Management
• Regulatory Affairs
• Risk Management
• Clinical Operations
• Site Managers and Staff
• Prinicipal Investigators

Instructor Profile:

Steve Schwartz, is the founder of Solaris Research Corporation. He has a background in basic virology research, progressing into 10 years clinical research program administration in the pharmaceutical industry. Entering the CRO industry, he performed clinical monitoring and clinical quality assurance field service using that expertise to achieve a management position at the director level. 10 years of CRO experience culminated in the formation of his full service CRO in 1989, under the initial name of Commonwealth Clinical Research Corporation- now Solaris Research Corp. Steve has also served as the investigator for several phase four clinical trials. He has served on an academic IRB. After a brief retirement he worked as Senior Manager, Global Clinical Operations/ GCP for Reckitt Benckiser Pharmaceuticals from March 2008 until July 2012. The objectives of successfully completing two clinical programs, building a global clinical research function, and developing a novel therapeutic biologic agent were completed in July 2012. Escaping from the corporate environment he is again in retirement he continues to speak and consult internationally to enable the sharing of his experience and expertise in CQA, regulatory affairs, and clinical operations including SOP, TMF, clinical monitoring, best practices.

Relevant to Clinical Quality Assurance, Steve and his associates have designed basic and advanced CQA courses for delivery to Health Canada and US Government agencies, to the pharmaceutical industry, and to academic institutions. Solaris Research provided clinical program management, clinical monitoring, CQA auditing and regulatory consulting. Solaris Research published an electronic clinical trial conduct newsletter from 2000 to 2008.

Steve has a BS degree in microbiology/infectious disease with graduate courses in immunology/virology and pharmacology, and business management. . Steve has made many presentations on clinical operations, clinical monitoring, study program management, and CQA.

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