#USA #Hampton #Registrar Corp #Adverse Events #Cosmetics Safety

Launch of the Adverse Events Protection Program

In a significant move aimed at enhancing safety for consumers and brands in the cosmetics sector, Registrar Corp and Denver Health have jointly launched the Adverse Events Protection Program. This innovative solution is designed to help cosmetics manufacturers worldwide effectively monitor and investigate adverse events associated with their products.

According to recent data from the FDA Adverse Event Reporting System (FAERS), the industry witnessed a staggering increase in serious adverse event reports in 2024, with cosmetics companies filing a total of 26,262 occurrences. This figure marks a dramatic five-fold rise compared to the previous year, highlighting the urgent need for robust monitoring systems in the cosmetics industry. The FDA mandates that companies investigate and report serious incidents leading to severe health outcomes—such as fatalities or life-threatening situations—within 15 days of occurrence.

The complexity involved in collecting, tracking, and reporting adverse events has posed significant challenges for cosmetics brands, particularly due to the sensitive personal and medical information required from affected consumers. The Adverse Events Protection Program offers a comprehensive approach by combining advanced technological solutions with medical expertise, thereby ensuring that cosmetics companies adhere to the latest regulations while safeguarding consumer health.

Key Features of the Program

The Adverse Events Protection Program incorporates several crucial features to assist companies in effectively managing adverse events:

• - Adverse Event Management Software: Designed for seamless consumer intake via mobile devices, this software streamlines the process of tracking investigations, reporting to the FDA, maintaining digital records, and ensuring audit readiness. This ensures that every incident is documented and managed appropriately.

• - Expert Medical Review: The program boasts an in-house clinical team from Denver Health, comprising qualified physicians who assess the severity of reported adverse events. They provide a comprehensive reporting package within five business days, ensuring swift and efficient handling of incidents.

Raj Shah, CEO of Registrar Corp, expressed enthusiasm about the collaboration with Denver Health, stating, "We are thrilled to partner with Denver Health to provide cosmetics brands with a seamless Adverse Events compliance solution from consumer intake to FDA reporting."

The Importance of Medical Expertise

Given the complexities surrounding adverse event investigations, many cosmetics companies lack the necessary in-house medical expertise. This puts brands at a disadvantage when it comes to comprehensively understanding and managing adverse events. The newly introduced Adverse Events Protection Program equips these companies with both the expertise and systems needed to respond promptly and effectively to any adverse incidents.

Denver Health, with its established reputation for medical excellence and public health initiatives, brings decades of experience that will significantly benefit cosmetics brands. Notably, their Rocky Mountain Poison and Drug Safety (RMPDS) unit has been providing valuable research services to consumer product companies and government bodies for over 65 years.

As Dr. Kevin Nork, Associate Director of Pharmacovigilance at Denver Health, noted, "Combined with Registrar Corp's AEM software, cosmetics brands now have a complete Adverse Events program from consumer intake to FDA submission."

Conclusion: A Step Forward in Consumer Safety

The launch of the Adverse Events Protection Program marks a pivotal advancement in the realm of cosmetics safety, ensuring that manufacturers can navigate the complex landscape of adverse event reporting with confidence. Through this initiative, both Registrar Corp and Denver Health demonstrate their commitment to protecting consumers while enabling cosmetics brands to maintain compliance with regulatory standards.

To explore the details of the Adverse Events Protection Program, visit Registrar Corp’s website.

About Registrar Corp

Registrar Corp is dedicated to keeping consumers safe and healthy by aiding food, beverage, cosmetics, medical devices, and drug companies in meeting compliance needs. It is the world's largest compliance firm, serving over 30,000 clients across more than 180 countries. With headquarters in Hampton, Virginia, their dedicated team operates in 20 offices worldwide to simplify compliance processes.

About Denver Health

Established in 1856, Denver Health is a non-profit healthcare provider headquartered in Colorado, USA. Their RMPDS unit provides expert clinical case reviews, toxicology insights, and medical guidance to manufacturers of both cosmetics and drug products.