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

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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

Daniela

Daniela Rota
Speaker
Pharmacovigilance & QA Manager
@PQE Group

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Stefano Cecchi

Stefano Cecchi
Speaker
Regulatory Affairs Manager
@PQE Group

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Leonardo

Leonardo Giraudo
Speaker
Veterinary Pharmacovigilance Expert
@PQE Group

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Annamria

Annamaria Piscopo
Speaker
Pharmacovigilance Compliance Expert
@PQE Group

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Ivo

Ivo Vrobel
Speaker
 GLP Expert
@Tekrolab

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Alessandro

Alessandro Agostini
Speaker
Doctor Medicinae Veterinariae
@GABA

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Sandeer

Sandeep Gupta
Speaker
Head of Pharmacovigilance and QPPV
@Chanelle Pharma

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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%
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For any questions or needs, feel free to write to us at associations-events@pqegroup.com

 

Location

Zanhotel Europa Bologna by Zanhotel Group
Via Cesare Boldrini, 11
40121 – Bologna (BO)

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