Cosmetovigilance – Vignette for the First Regulatory Year of EU Regulations – Impact on North America and Europe

Drug Safety, Life Sciences, Pharmaceutical Regulation ,
  • Thursday, June 05, 2014

set of cosmetic bottlesThe first anniversary is approaching for European regulations for mandatory reporting of serious adverse events temporally related to cosmetic use. Reporting of these events is often complicated by a product’s status as drug in one region, but a cosmetic in other regions. This webinar focuses on tips and best practices for navigating through the complex regulatory landscape of cosmetic adverse event reporting. All new regulations impact resource allocation and prompt changes in workflow.

Using a case vignette, this webinar will walk through reporting a serious dual status case to demonstrate an efficient and quality based workflow. Demonstrated is how dual workflows seamlessly dovetail to prepare and report the more comprehensive analysis required for cosmetic serious cases. Using a unique business and workflow process, the attendees will leave the webinar with simple but effective methods for enhancing their workflows in addition to enhancing surveillance. This can be accomplished with minimal effect on headcount.

Managing critical risks that may have significant downstream impact will also be highlighted.



Sharon Donatucci, Vice President of Pharmacovigilance Operations, Drug Safety Alliance, Inc.

Sharon Donatucci is responsible for overseeing DSA’s case management function and ensuring that resources are properly allocated for optimal operating capacity and effective, efficient delivery of services.

A member of DSA since its inception in 2000, Ms. Donatucci previously served as Senior Director of Training and Quality Control, overseeing the quality aspects of case processing to identify training needs and ensure client satisfaction. She also managed all aspects of DSA’s employee development training program, facilitating classes for new hires and audit compliance courses for all employees and developed the company’s Drug Safety Case Manager Certification Program. Prior to her training role, she served as a Drug Safety Associate and Project Manager for DSA.

She received her Bachelor of Science degree in Electrical Engineering from San Jose State University in San Jose, California.

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Who Should Attend?

This webinar will benefit those in the following areas for cosmetic products/consumer healthcare products/cosmetic manufacturers:

  • Marketing
  • Post-market Product Surveillance
  • Regulatory Affairs
  • Compliance
  • Legal
  • Product Testing and Safety

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Founded in 2000 and acquired by UDG Healthcare plc in 2012, as part of its Ashfield Division, Drug Safety Alliance, Inc. (DSA) is a global leader in safety and risk management services supporting Pharmaceutical, biotech, medical device, consumer health and animal health organizations. Uniquely focused on pharmacovigilance, DSA provides comprehensive outsourced solutions and modified services to augment existing safety departments.

DSA’s commitment to pharmacovigilance allows you to focus on your core business, while we partner with you to promote patient safety and product longevity. We achieve this by fostering the open exchange of ideas among organizations throughout the pharmacovigilance community. By delivering innovative approaches to Global Case Management, Aggregate Report Development, Literature Search Services, Signal Detection and Surveillance, Risk Management Services, Safety System Implementation, and Medical Information and Call Center Services, DSA is helping to advance the practice of pharmacovigilance on a global scale.

DSA is headquartered in Research Triangle Park, North Carolina.

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