This webinar focuses on the importance of consistent quality practices for management of veterinary pharmacovigilance, particularly, adverse event data. Many times, the impact of data management during the workflow is underestimated leading to added resources for remediation.
Given that the quality and integrity of veterinary pharmacovigilance data can be highly variable, it is crucial to develop best practices to minimize the risk of generating ‘dirty data.’ Attendees will receive a timely overview of workflow management that positively impacts the sequela of ‘dirty data’ in veterinary pharmacovigilance. While safety databases can provide analytical views of product profiles, often this will be of little or no value if best practices and routine quality control practices are ineffective.
Dr. Helms will share take home tips in managing adverse event and product quality data throughout the lifecycle of adverse event data management. From selecting VedDRA terms and harmonizing critical causality assessments, attendees will be delighted to find solutions for workflow conundrums. Examples are shown of workflow practices that generate meaningful results for use in time bound regulatory and business settings.
In veterinary pharmacovigilance, data mining is not required, but it can be a powerful tool for detecting safety signals. Paired with high quality internal adverse event data (minimal risk of ‘dirty data’) veterinary pharmacovigilance functional groups have greater confidence in robust and efficient analytical systems. These practices assist in the integration of veterinary pharmacovigilance groups into business development as well as meeting regulatory and ethical obligations for good product stewardship.
Renee Helms, DVM, Director, PV Operations, Drug Safety Alliance, Inc.
Renee Helms, DVM, is the Director of PV Operations for Drug Safety Alliance’s Animal Health Drug Safety team. As Director of PV Operations, she provides strategic support and guidance in the end to end veterinary pharmacovigilance activities and drug safety solutions. This includes case processing, audit preparation, management of adverse event data and regulatory submissions for both clinical and post-marketed animal health products. Dr. Helms also participates in veterinary regulatory intelligence with a specialized DSA team to focus and assist Clients in efficient and compliant workflows to meet the wide range of regulatory requirements for maintaining the life cycle of animal health products worldwide.
Dr. Helms earned her Bachelor of Science degree in Business Management from the University of North Carolina at Wilmington in Wilmington, NC, and is a graduate of North Carolina State University College of Veterinary Medicine in Raleigh, NC. In addition to her role at DSA, Dr. Helms continues to practice as an Emergency Veterinarian at the Animal Emergency Clinic of Cary in Cary, NC. She performs emergent surgical procedures and manages after hour’s emergency, critical care and urgent care for small animal patients. She has also been responsible for the design and implementation of the Clinic’s continuing education training program for veterinary technicians and assistants. Dr. Helms has been active in veterinary practice for 13 years. Prior to joining DSA in 2011, she was a consulting veterinarian for PPD, Inc. in Morrisville, NC.
Who Should Attend?
Senior level executives as well as managers involved in the following areas for animal health products:
- Quality Assurance
- Regulatory & Compliance
- Call Center
- Case Processing
This webinar will benefit veterinary medical writing organizations, veterinary trade associations, distributors of animal health products, medicated feeds, or specialty companion animal foods/treats.
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.