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

This webinar will provide a summary of the additional medicare reporting requirements under the Sunshine Act rules, and tips for assuring compliance to protect both the manufacturers of FDA regulated products and physicians.

This training on global medical device regulations will discuss the regulatory framework for medical devices in US, EU and Canada. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these countries.

This medical device 510(k) training will help you understand the basics of 510(k) submissions and discuss how to develop and execute an approval strategy ensuring the fastest possible path to market.

This session will discuss in detail the Final Rule for the Physician Payment Sunshine Act, its impact and how to prepare for it. You will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to CMS.

This clinical research QA training will provide practical advice for clinical research sites on when and how to get started with building their quality assurance program. A table of contents of the most critical SOPs will be provided.

This training on Asian medical device regulations will discuss the regulatory framework for medical devices in China, Hong Kong, Japan and Korea. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these Asian countries.

This 3-hr virtual seminar will offer a comprehensive ICH GCP training for all healthcare professionals involved in clinical research.

This webinar on dietary supplement adverse event reporting will explain the requirements under federal law as to when serious adverse event reports must be submitted to the FDA, what information and when it must be submitted. In addition, it will highlight the recordkeeping requirements under the law pertaining to all adverse event reports.

This healthcare compliance training will explain how the FCA, the AKS and the Federal Physician Self Referral Law (Stark II) work, the prohibitions, exceptions and safe harbors. It will review recent examples to show how they interface and can potentially impact you/ your organization.

This 90-minute webinar will examine the many myths that get in the way of clinical standards adoption and demonstrate how complying with required standards benefits both the FDA and sponsors.

This GCP compliance training will discuss the regulatory requirements for handling protocol deviations and violations and the importance of documentation that is required. The presenter will provide specific examples and proven tips for handling instances of protocol violations.

This webinar will assist clinical research personnel in developing/acquiring SOPs for their site. You will learn how to create a compliant but user–friendly set of SOPs that can pass regulatory audits and also be a useful tool for the site staff.

This webinar will familiarize you with FDA requirements for electronic and digital signatures, and the agency's inspection and enforcement practices. Particpants will recieve complimentary hand-outs for easy implementation.

This webinar will discuss how to manage supply chain risk to optimize clinical trial supply and also manage demand side requirements, risk of stock out, cost management etc using novel tools and technologies.

This 90-minute webinar will explain FDA's 1997 guidance on 510(K) for device modifications and show how to integrate the evaluation into your design change program. The webinar uses numerous Warning Letters to illustrate the points, and helps you learn from others.

This webinar will discuss the role of the ethics committee, the trial sponsor and investigator in providing an adequate Informed Consent (IC). It will discuss challenges and practical limitations in ensuring your informed consent is GCP compliant.

This 3-hr training on South Korean regulatory compliance requirements for life science products will discuss about the regulatory structure, clinical trial requirements and the conduct of running clinical research in South Korea.

This webinar will examine and highlight differences among non-inferiority (NI) trials, equivalence, and superiority study objectives and designs. It will also review current FDA guidance for NI clinical studies.

This webinar will train you on interpreting FDA's new guidance document on risk-based monitoring. It will include a case study demonstration on how any biopharmaceutical, medical device, and CRO could leverage the applications of breakthrough techniques to implement risk-based monitoring.

This webinar will help you manage the risks associated with GCP non-compliance at a pivotal investigator site. The training will follow a case-study approach to help you learn how to determine investigator non-compliance and guide you in deciding whether or not to file the efficacy study data in a regulatory application.