Healthcare professionals, toxicologists and other scientists at SafetyCall International have been managing product related adverse events on behalf of manufacturers for decades. During this time SafetyCall has managed more than 3,000,000 incidents and helped manufacturers with early detection of safety issues and implement strategies to manage and mitigate adverse events. SafetyCall’s experience and methodology in this important area has recently …
Dr. Kingston Speaking at CPSC From A-Z and Beyond
Dr. Rick Kingston will be speaking at the Consumer Product Safety Commission (CPSC) From A-Z… and Beyond, a full day conference in Washington, DC providing participants with a thorough understanding of the regulations administered by the US CPSC.
Dr. Kingston is speaking from 10:45-11:30 on Post-Market Surveillance. His presentation will cover:
- Data used by CPSC in regulatory process
- NEISS Data
Manufacturers role in adverse event reporting and postmarket surveillance to be discussed at the Human Performance and Dietary Supplements Summit
Rick Kingston, President, Regulatory and Scientific Affairs and Sr. Clinical Toxicologist at SafetyCall International will speak on the topic of adverse event and post market surveillance related to human performance dietary supplement at the upcoming summit sponsored by the NIH Office of Dietary Supplements, NSCA, and Abbott Laboratories.
Dietary supplements to enhance athletic and general human performance are widely …
Adverse Event Reports on the Rise – Is there a Safety Issue?
Does FDA’s expectation of increased serious adverse event reports involving dietary supplements signal a safety issue with these products?
In recent months, the U.S. Food and Drug Administration (FDA) has been advising dietary supplement companies to review their SOPs regarding adverse event documentation and reporting of serious adverse events to the FDA. FDA believes that there are good indications that …
The Importance of Best Practices
As Rick Kingston, President of Regulatory and Scientific Affairs at SafetyCall International, has said on numerous occasions, it is important for dietary supplement manufacturers to not only ‘meet the letter of the law’ in regards to manufacturing regulations, but to also define and follow best practices for compliance with these regulations. Dr. Kingston was quoted in “The Tan Sheet” article …
Best Practices in Regulatory Reporting: Are You Compliant with cGMPs?
As Dan Fabricant, Director of the FDA’s Dietary Supplements Program, states in recent communications with Industry, he views the level of non-compliance of dietary supplement manufactures with cGMP’s (current good manufacturing practices) as astonishing. Based on audits that have been completed by the FDA’s compliance division they have estimated that nearly 70% of dietary supplement manufacturers are currently not up …
Is your Company Compliant? Learn More at our “Best Practices” Webinar
“Best Practices” for post-market surveillance & regulatory reporting of dietary supplement and OTC drug adverse events.
Although “Best Practice” AE Processes can be fairly straightforward, there are a variety of challenges a manufacturer must overcome when implementing an AE system. These can include designing a database, developing SOP’s for managing, documenting, analyzing and reporting indicated events, and overcoming internal …
Dr. Rick Kingston to Present at CHPA’s Regulatory and Scientific Conference
Best Practices in Safety Surveillance
The Landscape of Post-Market Surveillance for Consumer Health Care Products
Thursday, May 10th, 2011
3:15 – 4:00 pm EST
Dr. Rick Kingston, president of regulatory and scientific affairs at SafetyCall International, PLLC, will be presenting at the Consumer Healthcare Products Association’s Regulatory and Scientific Conference. His lecture will discuss how the regulatory and pharmacovigilance environment …