Good Clinical Practices (GCP) - Understanding and Implementing the Current Global Requirements 2017

Topics

• Good Clinical Practice regulations require that clinical trials be consistent with regulatory requirements
• Adherence to ethical principles as laid out by the Helsinki Declaration
• Trials should thoroughly assess the risks and benefits inherent in a clinical research
• Good Clinical Practice regulations require the sponsor to make available clinical and nonclinical data from the study to support further related research
• 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
• The clinical research should ensure the wellbeing of its subjects
• Good Clinical Practice regulations requires the sponsor to obtain informed consent from each of the subjects
• A clinical research program must be subject to oversight from an independent Ethics Committee
• There should be thorough confidentiality of information relating to the subject
• Good Clinical Practice regulations requires adherence to set documentation practices
• 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
• 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
• GCP Regulations, Guidance and Additional Resources
• New Clinical Trials Regulation - EU No. 536/2014 (repealing Directive 2001/20/EC)

Who should Attend

• 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
• Clinical Research Associates who want a greater understanding of the medical device clinical trial process and their role in it
• 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 Professionals who may be new to the device industry or new to the clinical trials process
• Regulatory Affairs Specialist
• Regulatory Affairs Management