The US Food and Drug Administration’s (FDA) Bioresearch Monitoring Program (BIMO) has a three-pronged mission: To protect the rights, safety and welfare of subjects in FDA-regulated trials; To determine the accuracy and reliability of clinical trial data submitted to the FDA in support of research or marketing applications for new products; To assess compliance with [...]
Medical Device and Diagnostic companies face particular compliance risks in the marketing, sale or delivery of their products to end users. Those risks don’t disappear – in fact, they may even escalate – when a company uses third party sales and marketing intermediaries to assist in the marketing, sale or distribution of its products. AdvaMed [...]
Posted on 24. Feb, 2014 by Rob Sims.
When building a compliance program for third party agents and distributors, what are the most significant risks to consider? That was the key issue discussed during a February 12th UL EduNeering webinar, Elements of an Effective Third Party Sales and Marketing Compliance Program, featuring Denise Pedulla and Peter Katz from Berkeley Research Group (BRG). BRG [...]
Sponsors and CROs, monitors and clinical personnel agree that consistent, high-quality learning, communication and management systems are essential to protecting participants in clinical trials while accelerating patient access to innovative, effective new drug therapies. Despite that common recognition, clinicians have grappled with unresponsive systems that lacked the education and communication tools to ensure human subject [...]
The FDA’s BIMO program is a wide-ranging program for ensuring patient safety and data integrity in the conduct of clinical trials. More than 1,000 inspections of study sites were conducted in 2012 (see FDA’s New Guidance Focuses on Risk-Based Monitoring). Often, site personnel lacked adequate knowledge to understand, implement and monitor applicable FDA regulations. UL [...]
Transparency International released its Global Enforcement Report 2012, identifying trends in corruption and anti-corruption enforcement globally. Most important for CCOs, the report shows the countries that represent the greatest corruption risks for global companies – and where the greatest compliance and training resources are needed. Some of the most significant highlights from the report: Foreign [...]
Life Science companies that manufacture combination products had until July 22, 2013 to comply with the Food and Drug Administration’s (FDA) final rule on current Good Manufacturing Practices (cGMPs) for those products. The new rule (part of 21 CFR Part 4) clarifies several points that had plagued the industry, including those products and entities that [...]
Posted on 10. Feb, 2014 by Sam Dranoff.
Sponsors of modern clinical trials carry responsibility for the protection of human subjects and the integrity of data from trials that can include hundreds of study sites across dozens of countries. Fulfilling that responsibility requires sponsors to monitor these study sites, clinical investigators and site personnel to ensure that protocols are followed, data is collected [...]
Inadequate Medical Device Reporting (MDR) procedures are in the top five for violations identified by FDA investigators when inspecting Medical Device facilities. Poorly written procedures, insufficient information, late transmission of complete reports to FDA, incomplete documentation, poor training – all these failures show up in 483s, Warning Letters and even product recalls. Medical Device companies [...]