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

The EU MDR is a comprehensive and complex regulation that combines all aspects of placing certain types of medical devices on the EU market into one regulation. It addresses the obligations of economic operators in this role, and provides for extensive databases, clinical requirements, classifications, conformity, and many defined relationships between agencies, member states, and other directives and regulations.

This webinar deconstructs the many parts of this regulation into the elements of lean documents and lean configuration, providing an opportunity to apply these principles as a way to create and maintain flexibility as this and new harmonized standards and regulations emerge.

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

This training will cover compliance requirements for running clinical trials in pediatrics, particularly in the EU to comply with the EU ethical considerations guidance for running clinical trials in pediatrics.

A key component of building a clinical research finance team is creating a staffing model that will support the health system’s clinical research portfolio. This course focuses on key metrics and KPIs to help attendees develop a staffing model for their organization.

Research Billing is complex and often manual process for many health systems. Attendees will learn how system integrations can improve the quality of a health care system’s compliance program

Activation of a clinical trial requires coordination and effective communication with several groups to be successful. Many health systems find that their trial activation times are prolonged and cumbersome. In this course, you will learn how to streamline activation times and utilize data to drive decision-making. This course provides the best practice approaches designed to create an efficient activation process.

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

Attend this webinar to understand the key requirements for risk management of clinical trials to comply with the latest focus on GCP inspection in this area including during the challenging environment of COVID-19.

This webinar covers the key requirements for CRO oversight compliance with the latest focus on GCP inspection in this area including during the challenging environment of COVID-19.

The current coronavirus pandemic has created problems for the management of ongoing clinical trials. In response, regulators have produced guidance aimed at protecting the safety of subjects and clinical trial integrity. This webinar sets out how the US FDA and UK MHRA expect those involved in the management of clinical trials to address these problems.

This webinar provides attendees with an introduction to FDA Import Alerts and what they are, examine why they are issued, show you where to locate them and how to determine whether a company or product is on one, and finally, provide strategic recommendations for removal from an alert.

Participation in clinical research activities presents challenges for an already complex revenue cycle and insurance system. The medical documentation needed to ensure reimbursement from third party payors is an essential part of this process. This course will review the segregation process and medical documentation needed to ensure reimbursement is sufficient to obtain reimbursement from third party payors.

Attend this webinar to explore some of the common sponsor errors. Become aware of the risk and liability of these decisions. Learn how to get approvals of submission, prevent enforcement actions, and loss.

This course will demonstrate the process of analyzing patient denials for trends related to participation in a clinical research study and leveraging this information to influence the coverage determination during Medicare Coverage Analysis (MCA) process. Participants will learn a 360 approach to increasing CRB compliance and reducing the burden to the patients participating in clinical research studies.

This course will describe the Medicare Coverage Analysis (MCA) process and the revenue cycle’s uses for this document. The course will describe the creation of the MCA and the multiple uses for this document.

This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.

This webinar will cover how to write a paper. Guidelines on framing a paper, journal selection and tips for publishable paper will be provided.

The emerging medical foods market in the United States is $1.3 billion annually with strong growth potential. As a distinct, FDA-regulated category, medical foods are gaining more widespread acceptance. However, they remain poorly understood by patients, pharmacists and physicians. This webinar will describe the regulatory pathway for approval, the definition of a medical food, examples of medical foods, and product development opportunities.

This webinar will provide you with a recap into what is Good Clinical Practice (GCP) and help you understand why the Revision 2 addendum was required. It will allow you to understand the implications of this revision for clinical research trials and gain the knowledge to fully comply with ICH GCP. It will provide an overview of what additions were added in the R2 addendum.

Data is key to decision making. This webinar will equip participants with knowledge, tools and resources to develop meaningful financial metrics to drive decision making. Key financial performance indicators for managing clinical research portfolios will be provided.