This webinar focuses on the process of signal detection and trending. Signal detection and trending is a powerful tool used in the management of veterinary medicines. The process of signal
detection (Signal Generation, Signal Strengthening, Signal Assessment and Signal Follow-Up) can generate more signals than true signals. Consequently, methods for ranking signals for further evaluation are required.
There are many methods and tools that can be used and focus will be on those that can be done routinely (VeDDRA coding, case assessment, etc.). For this to be effective, it is essential that harmonized standards are used for the coding, management and analysis of pharmacovigilance data. Examples of signal detection using these tools will be included. Regulatory Agencies are also carrying out signal detection and the process used will be outlined.
Finally, the presenter will discuss how signal detection and trending fit into Benefit-Risk assessments and the management of veterinary medicines.
Declan O’Rourke, MVB DipM MBA FRCVS, Ortec Consultancy, UK
Declan O’Rourke has over 20 years of experience in the industry where he has held technical, marketing, product development, clinical development, production and pharmacovigilance roles. He is a veterinary surgeon, holds a Diploma in Marketing, a Master of Business Administration and was awarded a Fellowship of the Royal College of Veterinary Surgeons in 1990. He now directs Ortec Consultancy, specializing in pharmacovigilance and represented IFAH-EU in the VICH Working Group on pharmacovigilance.
He is a Special Lecturer in Veterinary Pharmaceutical Development at Nottingham Veterinary School, President of British Cattle Veterinary and a member of the Veterinary Residues Committee and the Veterinary Products Committee (VPC).
Who Should Attend?
Senior level executives as well as managers involved in the following areas for animal health products:
- Quality Assurance
- Research and Development
Job functions also include:
- Qualified Persons
- Drug Safety Officers
- Veterinary Medical Writing
This webinar will benefit veterinary medical writing organizations, distributors of animal health products, medicated feeds, or companies such as “wellness” or prescription foods for companion animals.
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.