Adverse Event Management Services for Dietary Supplement Companies

By Rick Kingston, President, Regulatory and Scientific Affairs In recent years, the FDA has increased inspections of dietary supplement companies regarding good manufacturing practices (GMPs), which include the processes, procedures and documentation that ensure the product is indeed what appears on the label. During the inspection process, the company’s adverse event documentation and serious adverse event reporting systems (SAERs), or …

Webinar: Best Practices for Adverse Event Management and Reporting

On August 9, 2012, Rick Kingston, President, Regulatory and Scientific Affairs at SafetyCall International, will be presenting as a part of the SOCAP International Webinar Series. His presentation is titled, “Best Practices for Adverse Event Management and Reporting” and will cover: Potential implications of pending and newly-implemented changes to regulations over adverse event reporting requirements for consumer products. FDA’s new …

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 …

Can Your Adverse Event Reporting Practices Affect Your Insurance Rates?

Rick Kingston recently spoke at the Consumer Healthcare Products Association’s Regulatory and Scientific Conference regarding Best Practices in Safety Surveillance. During his presentation, Rick explained how dietary supplement firms and manufacturers with best practices in place for adverse event reporting are most likely to receive the best insurance rates. Rick was quoted in “The Tan Sheet” Vol. 20, No. 22 …

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 …

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 political …

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 …