Day 1 | Day 2
Regulatory agencies’ changing focus and expanding expectations regarding GCP compliance will be addressed at the Second Annual Clinical Auditing Forum. Attendees can expect presentations on auditing best practices, strategies, and techniques to ensure that solid GCP compliance and scientific and ethical standards are maintained throughout the conduct of clinical trials. Sessions will be focused on developing and strengthening auditing programs, implementing proven techniques for audit planning, and ultimately ensuring clinical research compliance through strategic approaches to clinical quality assurance. FDA and international regulatory agency expectations and recent inspection trends will be discussed. Speakers will present real-world examples of risk-based approaches to auditing sites, systems, and providers.
Attend the EVENT Short Course*
Wednesday, June 6, 2012 8:30 AM - 11:00 AM
Proactive Approaches to Vendor Management
Michael J. Harte, Founder and President, The Harte Group
James Kirwin, Vice President and Senior Advisor, Clinical
Development Operations, The Harte Group
* Separate registration required.
Wednesday, June 6, 2012
8:00 am Event Short Course Registration and Morning Coffee
11:00 Main Conference Registration
12:45 pm Barnett Welcome & Chairperson’s Opening Remarks
1:00 Review of Recent FDA 483s, Warning Letters, and FDA Activity Related to GCP Non-Compliance
Doreen McGirl, Senior Manager, Global Clinical Compliance, Merck
Much can be learned by reviewing FDA inspection reports and keeping current on upcoming FDA guidances related to GCP non-compliance. Sponsors are encouraged to use these documents as foundations for group meeting agenda topics, to encourage thinking and thus discussion amongst colleagues to improve their own quality systems. This presentation will discuss recent FDA Activities, and provide insight into how sponsors can implement these discussions, and subsequently improve their quality systems by reviewing guidances, recent inspection reports, and non-compliance findings.
1:45 Clinical Trial Self-Monitoring and Auditing Plans
Kelly Willenberg, BSN, M.B.A., CHRC, President, Synergism, LLC
Marianne Parnell, BSN, OCN, M.B.A., Manager, Medical Affairs, Sigma-Tau Pharmaceuticals, Inc.
Clinical Trial Self Monitoring and Auditing plans should be established at every facility performing trials. What are industry standards and how should you set one up? This session will explore this issue from the site and sponsor perspective. Attendees will come away with a commitment to providing a high standard of excellent data and unsurpassed billing compliance quality. Exceed even your own expectations in how you do your clinical trials billing and quality compliance.
2:30 Preparing for a Regulatory Inspection: Investigative Sites
Anna DeMarinis, Principal, The DeMarinis Group, LLC; former FDA Consumer Safety Officer, Health Sciences Administrator, and Policy Analyst
As your clinical trials near completion and you contemplate preparing your FDA marketing approval application, you also should be thinking about which of your clinical Investigators might be inspected by the Agency as part of the application review process. This presentation includes (1) an overview of FDA’s clinical Investigator inspection process, including site selection and inspection conduct and follow-up, (2) steps you can take to help your sites prepare, including site audits and FDA inspection preparation visits, and (3) recent FDA inspections statistics and key inspection findings.
3:15 Refreshment Break
3:45 Preparing for a Regulatory Inspection: Sponsors and Monitors
Swati Tendolkar, Program Manager, Global System Quality Assurance, Janssen R&D, a Johnson & Johnson company
The session will provide overview of the FDA Sponsor-Monitor Inspection Process, such as the inspection objectives and the types of sponsor systems reviewed during an inspection. Additionally, your speaker will provide information regarding preparing for a Sponsor-Monitor inspection, inspection logistics, and activities involved during an inspection. We will also review types of FDA Sponsor-Monitor inspection findings, responding to the inspection findings, effective corrective and preventive plan development, and the post-inspection activities.
4:30 Preparing for a Successful eClinical Inspection
Rod Thorell, Director, Quality Management & Compliance, Quality Management & Compliance, PHT Corporation
Global regulatory bodies are making changes that dictate a preference for electronic data capture within clinical trials. This session will demonstrate the critical characteristics that must be properly defined and controlled for a successful submission and inspection. Participants will learn about flaws in key pieces of objective evidence and processes that could jeopardize the acceptance of data. Attendees will learn how to properly execute a successful audit program of vendor oversight, study team activity, and site processes.
5:15 Welcome Reception (Sponsorship Opportunity Available)
Attend the Dinner Short Course*
Wednesday, June 6, 2012 6:00 PM - 8:30 PM
SOP Assessment: Ensuring GCP Compliance in Standard Operating Procedures (SOPs)
Instructor: Elizabeth Ronk Nelson, MPH, President and Senior Consultant, Regulatory Risk Management
* Separate registration required.
Day 1 | Day 2