We recently discussed what CAPA means and why it’s important. Since many people in our field express confusion between the “CA” and the “PA,” I’ll quickly explain the difference between corrective action and preventive action. To put it simply, a corrective action can be defined as specific steps taken to address observed non-conformities or […]
Regulatory Compliance
Top 5 Life Sciences Blog Posts From August 2015
Now that September is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in August – they’re ranked in order of popularity, with number one being the most viewed piece.
What Are CAPAs And Why Are They Important?
In a handful of upcoming blog posts, we’ll be discussing a hot topic in our industry, along with a complementary piece of technology that might surprise you. The term Corrective and Preventive Actions, more commonly known as CAPAs, refers to an elaborate combination of processes and procedures used to maintain compliance with the following […]
Leverage data to improve compliance like the SEC and FINRA
The SEC’s Office of Compliance Inspections and Examinations (OCIE) is responsible for protecting retail investors and assessing market-wide risks, but now is shifting its attention also toward figuring out how to leverage data analytics to identify potential for illegal trading activities, conflicts of interest or other misconduct, according to a recent article by ThinkAdvisor, Compliance Data Analytics: Do […]
Financial services customers are now expecting compliance expertise
A recent survey of asset managers, broker/dealers, alternative managers and wealth managers found that compliance is now a core business practice of financial services firms, yet many are not yet devoting the financial resources toward making these programs truly effective. Firms have been facing enhanced scrutiny for years: 81% of respondents stated that they are […]
Talk To The Hand: Pharma Wins Freedom Of Speech Case
In May, I wrote about how pharmaceutical companies were attempting to stop the FDA from banning the promotion of drugs for off-label uses. According to an Amarin press release issued on August 7, 2015, a United States District Court sided with the pharmaceutical company, saying that they “…may promote to healthcare professionals certain uses […]
What Kim Kardashian Taught Me About Pharma
In case you missed the headlines in the last few days, the FDA issued a Warning Letter to Duchesnay over Kim Kardashian’s Instagram post promoting Diclegis, the pharmaceutical company’s drug for “the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management,” commonly known as morning sickness.
Naming Drugs And Medical Devices Is An Art
Naming drugs and medical devices is an art form that requires creativity, knowledge of linguistics, and an understanding of how to navigate the regulatory landscape. It’s easy to think of names, but coming up with ones that are meaningful and memorable, yet different enough than anything currently on the market, is another story. The International […]
Analysis Finds Reporting Delays For Serious Adverse Events
According to a recent research letter in the Journal of the American Medical Association (JAMA), an analysis of serious adverse event (SAE) reports from January 1, 2004 and June 30, 2014 (with certain exclusions) concluded that drug companies were more likely to delay the reporting of such instances within the required 15 calendar days, if […]
Risk-Based Monitoring, In Layman’s Terms
One of my LinkedIn contacts shared the video Risk-Based Monitoring vs Remote Monitoring Finally Explained, in which Dan Sfera of www.theclinicaltrialsguru.com explains both concepts in layman’s terms. In essence, the idea of Risk-Based Monitoring (RBM) is to leverage the data in existing IT systems to spot, rectify, and prevent issues relating to the execution of […]
The Yellow Card You Can’t Argue With
You can’t argue with it because it’s a good idea. Yellow Cards have gone digital. Not the ones used in soccer/football, but the ones used in the UK for reporting adverse events. When governments undergo digital transformation, you know it’s not a fad. After all, they’re not typically early adopters…of anything. Last week, the […]
Finding All Relevant Documents When A Drug Has Many Names
Most of us “regular people” refer to pharmaceutical products by their trade name, but that’s not the case among life sciences professionals in research and development departments. In fact, during a product’s lifecycle, chances are it has been referred to by at least four names: a chemical compound, a company code, a generic name, […]