|
|
-
Do you the clinical investigator and your institution administrators understand the exposure and liability to the often severe professional and financial consequences of a failed regulatory inspection of your study site?
Institutions and investigators commonly make three unfortunate false assumptions:
- That the regulatory authority cannot adversely impact the clinical investigator.
- That the clinical monitoring functions by the CRO or sponsor CRA provides indemnification from a failed regulatory inspection.
- That a failed regulatory inspection of a clinical research investigator site does not adversely impact the institution.
- Do you, the clinical investigator as the target of the regulatory inspection, have the knowledge of the inspection process, or the skills to respond appropriately during and afterwards to the regulatory inspection?
Does your institution provide support and training for the regulatory inspection of your clinical site?
- Can the investigator or the institution avoid the very common and unnecessary escalation of minor conduct deviations to critical regulatory observations?
This escalation is frequently associated with:
- The investigator’s failure to adequately prepare and present the study documentation
- The investigator’s failure to respond appropriately to the regulatory inspection interrogation.
- The institution’s inability to support the required demonstration of investigator regulatory GCP compliance.
In conclusion – A well intentioned investigator alone does not enable a successful clinical site inspection. An overly cooperative investigator that is not trained for the conduct of a regulatory inspection may in fact create non-compliance findings that do not exist.
|
|
Benefits to the Participants
|
|
This course will benefit the investigators and site staff who will be inspected, the sponsor CRA, and institution quality staff and clinical administrators. |
|
Issues to be covered
|
This course will provide:
- A basic understanding of the clinical site inspection process
- For investigators and staff
- For institution administrators to understand the process and the liability.
- The need for clinical site training for a pending inspection.
- The standard regulatory questions.
- The regulatory inspection objectives and perspective.
- What not to say to the expected regulatory interrogation questions.
- Reality based examples to demonstrate what works and what doesn’t work- and the consequences thereof.
|
|
Who should attend
|
- Investigators and Study Coordinators
- R&D staff
- IRB Members (Helsinki Committee)
- Auditors of clinical trials committees - במרכזים הרפואיים חברי ועדות הביקורת הפנימית
- Lawyers who consult on matters pertaining to clinical trials
|
|
About the Speaker
|
Stephen Schwartz
Sr Manager, Global Clinical Operations /GCP
Reckitt Benckiser Pharmaceuticals
Steve started with a degree in microbiology/infectious disease when dirt was new. After 10 years as a medical section administrator in pharmaceutical industry clinical research he moved into the CRO arena. He remained in that industry for 28 years. For 18 of those years Steve directed the full service CRO that he founded in 1990. He has directed trials as large as 135 investigator sites.
He has extensive experience as a CRA, program manager, regulatory consultant, and Clinical Quality Assurance auditor and instructor to industry and government agencies. He has broad experience in devices, biologics, imaging, diagnostics, and most areas of therapeutics. He has served as an investigator on phase four studies and has served on an IRB.
Steve has published an international clinical trial conduct newsletter (8 years) and has been a frequent presenter of webinars over a broad range of topics for FDA News and Thompson Publishing. GCP, Regulatory, and CQA training of academic, government, and pharma staff have been a large part of his activities since his semi retirement in 2003.
In 2008 he was excited to come out of retirement to work for Reckitt Benckiser Pharmaceuticals; growing and directing their QA, GCP, and Clinical operations functions to its currently rapidly expanding global status. He is responsible for the conduct and compliance of all clinical trials at RBP. He is directing clinical teams in many countries.
His many years of experience and his unique interactive training modules enable a very efficient level of participant interaction that empowers the participants to share their expertise within the group.
Steve continues to provide training and speaking opportunities in this latest phase of his professional career. Steve believes that knowledge not shared is knowledge wasted.
|
|