Multi-stakeholder workshop on draft 'Regulatory Science to 2025' strategy (stakeholders for human medicines)

• Date:
  Monday, 18 November 2019
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The European Medicines Agency (EMA)'s multi-stakeholder workshop on itsRegulatory Science to 2025 strategy for:

• sharing the outcome and key messages from the analysis of the public consultation on the strategy;
• reflecting on the likely prioritisation of core recommendations;
• identifying concrete actions in order to implement the key goals and core recommendations, addressing expertise development and process evolution.

The participants include patient representatives, healthcare professionals, academia, health technology assessment bodies, payers organisations, trade associations and regulators.

Documents

Agenda - Multi-stakeholder workshop on draft 'Regulatory Science to 2025' strategy (stakeholders for human medicines)

Presentation - EMA Regulatory Science to 2025 - Welcome

Presentation - EMA Regulatory Science to 2025 - Overview of the outcome of the publication consultation

Presentation - EMA Regulatory Science to 2025 - Support developments in precision medicine, biomarkers and ‘omics’

Presentation - EMA Regulatory Science to 2025 - Support translation of advanced therapy medicinal products (ATMPs) into patient treatments

Presentation - EMA Regulatory Science to 2025 - Create an integrated evaluation pathway for the assessment of medical devices, in vitro diagnostics and borderline products

Presentation - EMA Regulatory Science to 2025 - Diversify and integrate the provision of regulatory advice along the development continuum

Presentation - EMA Regulatory Science to 2025 - Recommendations related to downstream decision making, HTA’s preparedness, and collaboration with payers

Presentation - EMA Regulatory Science to 2025 - Promote use of high-quality real-world data (RWD) in decision making

Presentation - EMA Regulatory Science to 2025 - Foster innovation in clinical trials

Presentation - EMA Regulatory Science to 2025 - Develop the regulatory framework for emerging clinical data generation

Presentation - EMA Regulatory Science to 2025 - Optimise capabilities in modelling, simulation and extrapolation

Presentation - EMA Regulatory Science to 2025 - Reinforce patient relevance in evidence generation

Presentation - EMA Regulatory Science to 2025 - Develop network-led partnerships with academia to undertake fundamental research in strategic areas of regulatory science

Presentation - EMA Regulatory Science to 2025 - Developing scientific advice/assessment pathways - Feedback from breakout session 3A

Presentation - EMA Regulatory Science to 2025 - Optimising evidence incl. RWD for decision making and communication - Feedback from session 3B

Presentation - EMA Regulatory Science to 2025 - Continue to support development of new antibacterial agents and their alternatives

Presentation - EMA Regulatory Science to 2025 - Support innovative approaches to the development, approval and post-authorisation monitoring of vaccines

Presentation - EMA Regulatory Science to 2025 - Reinforcing patient relevance in evidence generation - Feedback from breakout session 5C

Presentation - EMA Regulatory Science to 2025 - Developing research partnerships with academia - Feedback from breakout session 5D

Presentation - EMA Regulatory Science to 2025 - Delivering the strategy

Presentation - EMA Regulatory Science to 2025 - Human Workshop - Draft briefing materials

Video recording