Posted on 19. Jan, 2017 by UL Compliance to Performance.
US FDA addressed data integrity in clinical trials earlier this year when the agency released Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations. The guidance emphasizes the need for both system and process controls to support data quality and the appropriateness and completeness of patient informed consent to enable such interoperability. [...]
Posted on 12. Jan, 2017 by UL Compliance to Performance.
As Life Sciences companies expand globally, opening new facilities or adding new suppliers, they face three main document and training management risks: compliance and regulatory issues, lost knowledge and change management. Regulatory Scrutiny: Global regulatory agencies, including US FDA, have made procedural control a top enforcement issue. In fact, the most cited US FDA observation [...]
The Mutual Reliance Initiative or MRI as it’s known is an attempt to leverage resources so that investigators and inspectors from FDA and trusted partners, such as those in the European Union, work together. The goal is for each organization to rely on each other’s inspections, avoid duplicating inspections, and conduct more inspections in areas [...]
Prescription Drug Event (PDE) records are the official records used by the Centers for Medicare & Medicaid Services (CMS) for Part D revenue reconciliation, coverage gap discount payments, STAR measures, 1/3 financial audits, and CMS program audits. They are critical to your success in managing Part D of your Medicare Advantage Prescription Drug (MAPD) Plan [...]
While online learning seems to be everywhere, sometimes we forget that there are many, many people who have never taken an online course and they may have a few questions about online courses. Here are a few frequently asked questions and some answers that will help make people feel more at ease taking online courses. [...]
The revised annual percentage increase for Part D reported by the Centers for Medicare & Medicaid Services shows a reversal in 2015, after six consecutive years of decline between 2007 and 2013 and a negative increase in 2014. The annual percentage increase for CY 2017 is double-digit (11.75%) for the first time in a decade. [...]
Posted on 19. Dec, 2016 by Karl Kapp.
In India, the Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. The organization has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control. The major functions of this organization include: Regulatory control [...]
Posted on 15. Dec, 2016 by Jefferson Barr.
The Department of Health and Human Services (HHS) issued the Final Rule implementing the prohibition of discrimination under Section 1557 of the Affordable Care Act (ACA) of 2010. The Final Rule, Nondiscrimination in Health Programs and Activities, will help to advance equity and reduce health disparities by protecting some of the populations that have been [...]
Posted on 12. Dec, 2016 by Rob Sims.
A couple of steps taken by global agencies in 2016 heightened the issue of Data Integrity in clinical trials. Back in August, as noted by the global law firm Ropes & Gray LLP, China FDA released draft guidance focused on clinical trial data forgery. CFDA is threatening to ban applicants if forgery is uncovered. “If [...]