In late January 2014, Assistant Attorney General Stuart F. Delery spoke at the CBI Pharmaceutical Compliance Conference, clearly identifying FDA’s expectations for the Life Science community and its own enforcement perspective. The speech serves all Life Science companies for its substance and tone. AAG Delery set the stage in his opening remarks, stating, “…one of [...]
Posted on 17. Apr, 2014 by Ellen Leinfuss.
Increasingly, Pharmaceutical and Medical Device companies are recognizing the value of investigator-initiated clinical research (IIR), also known as investigator-initiated trials (IIT). IITs serve an important function in the development and use of drugs and devices. Even though a drug or device company may commit more than a decade and $1 billion to bringing a new [...]
Posted on 15. Apr, 2014 by Ellen Leinfuss.
When we conducted our annual benchmarking study with clients in 2013, we learned just how far clients have advanced along the “Quality-based Learning Maturity Model” – I wanted to explain this model in a bit more detail, as it’s stirring some interesting discussions with clients who benefit from our learning management system, as well as [...]
For Health Care companies, Fiscal Year 2013 was a year of record-setting fines and settlements under the False Claims Act. According to the US Department of Justice (DOJ), the government recovered $3.8 billion under the Act, leading the Assistant Attorney General for DOJ’s Civil Division to describe 2013 as a “banner year for civil fraud [...]
Posted on 28. Mar, 2014 by Richard Robbins.
One of the most challenging and difficult issues Life Science companies face is assessing risk throughout the product lifecycle. FDA expects companies to assess the risk to users, patients, and the environment. Regulatory agencies recognize the ISO 14971 standard as a benchmark for medical devices and the ICH Q9 guidance for pharmaceuticals/biologics as standards to [...]
Posted on 25. Mar, 2014 by Karl Kapp.
A leading manufacturer of medical devices and supplies, diagnostic imaging agents and pharmaceuticals, had a plan: they were faced with a challenge: they needed to put into place a quick, easily accessible way to share and discuss quality events, ideas and initiatives across the entire organization. To meet its aggressive business, quality and compliance goals [...]
Posted on 12. Mar, 2014 by Ellen Leinfuss.
The theme of the conference was ‘Sustaining Regulatory Compliance in the Pharma Industry.’ The summit offered an exclusive platform for the pharmaceutical sector that brought together prominent industry experts, learning technology leaders, R&D heads and international policy makers participating in the networking and discussion from across the world. The panel discussion of the summit provided [...]
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 [...]