Veterinary Excellence:
Innovating Quality and Safety in Pharmacovigilance and Regulation
Insights into Trends, Guidelines and Future Challenges for a Safer Veterinary Industry
Thursday, April 10, 2025 • Bologna or Online
Click to navigate



The event offers a valuable opportunity for professionals in the veterinary sector to stay updated.
Key topics include quality planning in veterinary pharmacovigilance, focusing on training, audits, and signal detection, as well as an analysis of the latest inspection findings.
The agenda will explore the European and Italian landscapes for veterinary devices, with a focus on safety and performance guidelines. The roles of local representatives and the auditing process will also be addressed, along with the revision of guidelines for bioequivalence studies on veterinary medicinal products. In the afternoon, topics will cover pharmacokinetic studies, risk management, and antimicrobial resistance under the "One Health" approach, highlighting the CVMP 2021-2025 strategy.
The event includes networking opportunities and direct discussions with experts to delve into the latest regulatory developments in the veterinary field.
Agenda
8.30 – 9.15 | Welcome coffee and registration |
Quality planning in veterinary pharmacovigilance: training, audit, signal detection. Last Inspections findings and trends. |
|
Veterinary devices: the European landscape and the Italian approach. Italian Guideline on safety and performance requirements of devices for animals. |
|
11.00 – 11.15 | Coffe break |
Local Representatives: role, qualification, task and duty, auditing. | |
Pratical evaluation of VMD UK & EMA regulation on signal management, Volume of Sales Submissions and Benefit/Risk evaluation. | |
Concept paper for the revision of the guideline on the conduct of bioequivalence studies for veterinary medicinal products. | |
Q&A | |
13.00 – 14.00 | Lunch and networking |
GLP: description of the conditions and conductions of pharmacokinetic and residue depletion studies. | |
Signal impacting on the benefit-risk balance: how to evaluate, RMM and their management. | |
15.45 – 16.00 | Coffee break |
Antimicrobial resistance under the "One Health" approach: status of the CVMP 2021-2025 strategy and future challenges. | |
Q&A |
Speakers
Pricing
In person
Standard in person |
€ 700 |
Early Bird discount if you register by February 28th 2025* *Only for in person attendees |
€ 500 |
AISA members discount | 15% |
For the second participant from the same company* *Not cumulative with AISA membership discount |
15% |
Online
Standard remote* *Only available for participants outside Italy |
€ 600 |
For the second participant from the same company | 15% |