"Clinical Regulation related Compliance trainings delivered by leading experts through webinars. This section contains compliance training affecting Clinical industry in areas - ICH-Compliance, Clinical Statistics, Good Clinical Practice, Clinical Research, Data and Safety Monitoring, Clinical Trials GXP and Clinical Data Management Systems."
This 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies, the requirements and compliance in a systematic, integrative (SI) manner.
Instructor : David Lim LiveTuesday, March 20, 2012
This webinar on clinical site audit/ inspection will outline the responsibilities of the Investigator and the clinical research coordinator during and after site audits/inspections and show what you must do to ensure preparedness at all times.
Instructor : Ornat katzir LiveTuesday, March 6, 2012
This 90-minute webinar will provide an overview of regulatory management for clinical trials. It will discuss key regulatory aspects of a clinical project such as clinical protocol management, IRB management, safety reporting, rules for recruitment programs, seeking advice from FDA, trial master files, and training requirements.
Instructor : Mukesh KumarLiveTuesday, February 28, 2012
This 90-minute webinar will cover the basic principles of pharmacogenomics and pharmacogenetics and will discuss in detail the steps behind implementing a clinical pharmacotenomic testing service.
Instructor : Dr. Alan Wu LiveWednesday, February 22, 2012
This training on hiring and managing CROs or AROs will show how you can ensure that you choose the right CRO/ARO based on the phase of the trial, the therapeutic area and the countries that the trials will be conducted.
This webinar on FDA GCP inspections will provide practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.
This Safety Reporting in Clinical Trials webinar will review FDA's recent major revisions to IND safety reporting requirements. It will explain FDA's current expectations of sponsors, investigators, IRBs, and other personnel responsible for reporting safety related information while conducting clinical trials with a new investigational product or a generic drug.
This SOPs for Clinical Trials training will cover ICH-GCP and ISO 14155 requirements for SOPs. It will outline steps to effectively develop and maintain SOPs and manage risks to your clnical research operation, through their use.
This FDA Clinical Trial Auditing training will cover the FDA regulations and the ICH GCP recommendations to ensure your site is prepared for a clinical trial audit.
George Spafford
George Spafford is a Principal Consultant with Pepperweed Consulting, LLC. He possesses a strong interest in the intersection of human factors, security and complexity in IT and how that impacts organizations. He is an experienced practitioner and has directed all aspects of IT operations in production environments, planning, implementation and improvement of IT processes. His expertise has lead to providing regulatory compliance, IT Governance, and process improvement training to colleagues in the USA, Australia, New Zealand and China.
