Clinical Trials Regulatory Compliance Training - Live Webinars, Recordings & CDs

This 90-minute webinar will discuss timelines for CDISC requirements among different market segments (drugs, devices, etc.) and provide clarity on what "compliance" with CDISC standards means. It will also cover resources that you can use for developing and interpreting these standards.

This webinar will help you identify key concepts from the US FDA Quality System Regulation (QSR - 21 CFR Part 820) that are applicable in the clinical arena, and show how you can build them into your clinical research activities.

This 4-hr Latin America Regulatory compliance requirements training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.

This webinar will outline the best ways to identify your trial needs to select a CRO, the right people to talk to, contract negotiations, ownership and accountability and challenges in the Sponsor-CRO relationship.

This webinar will cover definitions, responsibilities, regulatory requirements and strategies to conduct Investigator Initiated (Sponsored) Trials - ISSs. It outlines the processes a company or investigator must undertake to be able to conduct such a clinical research study in humans.

This webinar will review the principal differences in regulations governing investigational device (IDE) studies and drug (IND) studies and help you understand where the regulations diverge and how this impacts the design and execution of device studies.

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.

This webinar will provide you with an overview of risk factors in clinical trials and discuss possible ways to mitigate, control, assess impact, and prevent them in your trial.

This webinar discusses the high risks of scientific misconduct in regulated studies. You will understand the main issues in producing study results of the highest integrity, learn how managers can implement a system for ensuring accurate and reliable data, understand the "red flags" of questionable data or reporting and develop a plan for identifying the high-risk steps in your operation.

This Clinical trial auditing training will provide an understanding of how to conduct compliant and successful clinical trials by defining FDA clinical trial audit procedures, audit program, audit planning and audit preparation.

This webinar on Trial Master File (TMF) for clinical research sites will show how you can create an FDA compliant TMF to ensure that it will pass inspection by FDA investigators and QA Auditors.

This webinar on issue detection and escalation in clinical trial settings will review the responsibilities of sponsors, investigators, IRB, vendors and CROs in clinical trial setting to maintain compliance. We will discuss how you can proactively monitor to prevent issues and in case of issue detection, escalate them.

This webinar on clinical trial audit/ inspection preparedness will discuss in detail about applicable regulatory and sponsor requirements, guidelines and SOPs, and how you can ensure that the conduct of clinical research at the investigative site(s) complies with them.

This webinar on IND and IDE Application management will help you understand the current FDA requirements for IND and IDE application post initial approval to proceed with the clinical trial.

This Webinar will help you understand the current FDA requirements regarding financial disclosure in clinical trials. It will discuss differences from the older requirements, and tips to assure compliance all through from the start of clinical trials till the submission of data in a marketing approval application.

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.

This 6-hr virtual seminar will focus on the regulatory compliance requirements and procedures for conducting Clinical Trials on Pharmaceutical Products in South Korea. It will also cover topics relating to pre-clinical and clinical requirements and address the structure of the regulatory agencies in South Korea.

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 SOPs will instruct you in creating, managing and implementing adequate SOPs that can impress even the FDA inspectors.

This Validation of Bioanalytical Assays webinar describes logical approaches to efficiently develop assays that will deliver quality data.