Regulation of veterinary medicinal products in the 21st century - - PowerPoint PPT Presentation
Regulation of veterinary medicinal products in the 21st century Addressing challenges and opportunities across the European Regulatory Framework EMAs Regulatory Science Response Veterinary Stakeholders Workshop Presented by Ivo Claassen
Regulation of veterinary medicinal products in the 21st century – Addressing challenges and opportunities across the European Regulatory Framework
EMA’s Regulatory Science Response
Presented by Ivo Claassen on 6 December 2018 Head of Veterinary Medicines Division, EMA
Veterinary Stakeholders Workshop
EMA’s Regulatory Science Response 1
Why now?
To monitor and sign-post emerging and future trends in science and technology To identify key priorities where new or enhanced engagement is essential to the continued success of the Agency’s mission To prioritise use of resources and external collaborations to strategically advance regulatory science To shape and influence the vision for the EU Medicines Agencies Network (EMRN) Strategy 2020–25
EMA’s Regulatory Science Response 2
How does EMA define Regulatory Science?
Regulatory science is defined as a range of scientific disciplines that are applied to the quality, safety and efficacy assessment of (veterinary) medicinal products and that inform regulatory decision-making throughout the lifecycle of a medicine. It encompasses basic and applied (veterinary) medicinal science and social sciences, and contributes to the development of regulatory standards and tools.
EMA’s Regulatory Science Response 3
The role of regulatory science at EMA?
View 1
Regulatory science Scientific advice Guidances B/ R assessment
View 2
Scientific advice Guidances B/ R assessment Regulatory science
EMA’s Regulatory Science Response 4
Vision—EMA Regulatory Science to 2025
To foster scientific excellence in the regulation of veterinary medicines for the benefit of animal and public health while facilitating and promoting innovation and access to novel medicinal products.
EMA’s Regulatory Science Response 5
Regulatory Science to 2025
SCG review output SciCoBo review output
WP Chairs interview
mapping Academia interview
mapping Industry interview
mapping Baseline report
Vet practitioners
EMA’s Regulatory Science Response 6
Strategic goal 1
To catalyse the integration of science and technology in drug development.
Strategic goal 2
To drive collaborative evidence generation to improve the scientific quality of evaluations.
Strategic goal 3
To address emerging health threats and availability/ therapeutic challenges.
Strategic goal 4
To enable and leverage research and innovation in regulatory science.
EMA Regulatory Science to 2025 - Timeline
Consolidation workshops and publication Critical feed into EMRN Strategy to 2025 Decem ber 2 0 1 8 Q4 2 0 1 9 Q1 2 0 2 0 Q4 2 0 1 8 Stakeholders’ workshops Human & Vet Q4 2018-Q2 2019 Public consultation
EMA’s Regulatory Science Response 7
June 2 0 1 9
Legislation follows science, not the other way round: embracing innovation ambition beyond implementation of NVR?
David Murphy, Chair of CVMP Nancy de Briyne, FVE Christian Siebert, DG Santé Jean-Pierre Orand, HMA Management Group Alexander Böttner, AnimalhealthEurope
8