Course "Good Clinical Practices (GCP) - Understanding and Implementing the Current Global Requirements" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
Why should you attend:
Areas Covered in the Session:
· Adherence to ethical principles as laid out by the Helsinki Declaration
· Good Clinical Practice regulations require that clinical trials be consistent with regulatory requirements
· Good Clinical Practice regulations require the sponsor to make available clinical and nonclinical data from the study to support further related research
· Trials should thoroughly assess the risks and benefits inherent in a clinical research
· The clinical research should ensure the wellbeing of its subjects
· Good Clinical Practice regulations require sponsors of a clinical trial to contain a clearly defined protocol that should be rooted in established scientific principles and practices
· A clinical research program must be subject to oversight from an independent Ethics Committee
· Good Clinical Practice regulations requires the sponsor to obtain informed consent from each of the subjects
· Good Clinical Practice regulations requires adherence to set documentation practices
· There should be thorough confidentiality of information relating to the subject
· The adherence to applicable Good Manufacturing Practices (GMP) by the sponsors when it comes to the manufacture, storing and handling of investigational products is another requirement of Good Clinical Practice regulations
· The principles of Good Clinical Practice regulations require the implementation of systems with procedures that bring about complete quality at every stage of the clinical trial
· New Clinical Trials Regulation - EU No. 536/2014 (repealing Directive 2001/20/EC)
· GCP Regulations, Guidance and Additional Resources
Who Will Benefit:
This seminar will provide an overview and in-depth snapshot of GCP regulations with a global overview. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the GCP process, including
· Clinical Research Associates who want a greater understanding of the medical device clinical trial process and their role in it
· Clinical Project Managers who are taking on a wider range of responsibilities and need to gain a greater understanding of the regulatory and practical issues involved in medical device clinical trials
· Regulatory Affairs Professionals who may be new to the device industry or new to the clinical trials process
· Clinical Investigators and Clinical Research Coordinators interested in gaining a broader understanding of their role and responsibilities and how these tasks relate to the overall research process
· Regulatory Affairs Management
· Regulatory Affairs Specialist
· Auditors
· Compliance Specialist
· Clinical Affairs
· Quality Assurance Management
· Consultants
Agenda:
Day 1 Schedule
Good Clinical Practices
· Introductions and Background
· What is GCP?
· Why should we have GCP? (ICH GCP/FDA CFR GCP)
· The Basic Principles of FDA and ICH GCP
· The 13 Basic Principles of ICH GCP
· Key ICH Guidelines and FDA Resources
· Compliance Guidance Manuals
· Impact of ICH GCP in the US
· FDA Acceptance of Foreign Studies
· FDA GCP Regulation
· FDA and International Regulations and Guidance Relating to Good Clinical Practice and Clinical Trials
· FDA and Institutional Review Board (IRB)/Independent Ethics Committee (IRB/IEC)
· Responsibility of the IRB/IEC
· Subject Informed Consent Forms
· Informed Consent of Trial Subjects
· IRB/IEC interactions with Sponsors and Investigators
· FDA's IRB requirements
· FDA Responsibilities of Sponsors and Investigators
· Investigator Records and Reports and Other Required Documentation for Good Clinical Practices