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9:05 – 10:30 |
VM4: Living with Post Authorisation Obligations – progress, challenges and future opportunities
Session Leader:
Dr. João Duarte da Silva - Senior Officer, Veterinary Medicines Unit, Direção-Geral de Alimentação e Veterinária (DGAV)/ General Directorate for Food and Veterinary Medicine, Portugal
Following the implementation of the Veterinary Medicinal Products Regulation in January 2022, significant changes were implemented in our regulatory network including pharmacovigilance data and signal manegent, the European Medicines Agency (EMA), together with the regulatory authorities in the Member States and marketing authorisation holders are responsible for detecting and managing safety signals. In this session we introduce the Industry view on Post Authorisation Obligations focusing on the safety data and signal detection and management.
We also approach the perspective of national competent authority with the contribution of the Head of Unit of Veterinary Medicines Products, DGAV, Portugal that will share the views of the NCAs on UPD Sales data and incidence calculation (EVVET) Data quality of the UPD and also a report of the current state of the assesement and approval of variation G1/18 for the aligned with QRD and also the Legal obligations regarding article 5.6 of the Regulation. The final theme of this session is related to the availability of veterinary medicines issue from the perspectives of the industry and challenges that can emerge.
9:05 Introduction
9:10 PhV safety data and signal detection: Kathrin Schirmann - Scientific Officer, Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)/The Federal Office of Consumer Protection and Food Safety, Germany
Safety data and signal management including signal detection.
EVVet data warehouse
- Current state
- Upcoming system developments
Variations requiring assessment (VRA) related to signal management.
9:30 Progress with Post-Authorisation Obligations from 2019/6 from an NCA perspective: Inês Martins de Almeida - Head of Unit of Veterinary Medicines Products, Direção-Geral de Alimentação e Veterinária (DGAV)/ General Directorate for Food and Veterinary Medicine, Portugal
Status of UPD, data quality and plans for new functionalities.
VRA G.I.18 alignment with QRD V. 9 NCA perspective.
Avaiability of VMPs in Portugal –UPD, National platforms, and electronic prescription platform (PEMV).
9:50 Industry view on Post Authorisation Obligations: Dr. Magali Quetin - Head of Global Pharmacovigilance EU & QPPV, Boehringer Ingelheim Vetmedica GmbH, Germany
Signal management
PhV Inspections
OPAD
- Reporting availability
- Reporting volume of sales
10:10 Panel discussion
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13:30 – 15:00 |
VM5: Digital Innovation to Support Animal and Public Health
Session Leader:
Jana Schalansky – Head of Veterinary Strategic Support at Veterinary Medicines Division (EMA), the Netherlands
Following the implementation of the Veterinary Medicinal Products Regulation in January 2022, regulators collect and exchange more data in the area of veterinary medicines, including pharmacovigilance and soon also antimicrobials sales and use. This creates a need to examine how to transform and use these data, with the aid of innovative digital methodologies, to support veterinary regulatory activities to foster animal and public health. The session will provide updates on the progress in the domain of human medicinal products, what can be learned and potentially leveraged for the veterinary domain, and the progress made so far. Finally, the session will provide a practical example to encourage a discussion on the challenges and opportunities arising from emerging technologies.
13:30 Introduction
13:35 Big Data – Human progress and direction: Ricardo Carapeto García - Head of Area of Environmental Risks, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)/ Spanish Agency of Medicines and Medical Products, Spain
Progress made in human domain
Real World Evidence impact on registration
DARWIN EU
13:55 Big Data – Veterinary progress & opportunities: Ilaria Del Seppia - Chair of the EU Vet Big Data Hub, Data Scientist - Veterinary Division at European Medicines Agency (EMA), the Netherlands
Progress made in veterinary domain
Veterinary Big Data strategy, workplan and data landscape analysis
Drivers and opportunities for future application of big data in the veterinary domain
14:15 Innovation in Veterinary Medicine – practical approaches to using Big Data: Dr Jade Bokma - Postdoctoral researcher, Faculty of Veterinary Medicine at Universiteit Gent, Belgium
Introduction DECIDE and example of one specific deliverable
Objectives, methods, progress
Potential future uses
14:35 Panel discussion
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