DIA’s mission – to work across the healthcare continuum to ensure patients receive the therapies they need – is more essential than ever during times like these. DIA acknowledges the time and effort that has gone into planning and preparing for the Regulatory Science Strategies Info day, and trusts that everyone will understand the need to respond to current, evolving health concerns in a responsible manner. These precautions are being taken to ensure the health and safety of our entire, global DIA family.
DIA is committed to exploring all possible avenues to provide a productive setting and a fulfilling meeting experience. We appreciate your patience as we work through technical requirements and any potential challenges.
The Regulatory Science Strategies Info Day provides the participants with the overview of the priorities of European regulators for the next 5 years. It will also bring in the view from other stakeholders and how they partner to advance the important topics promoted by the regulatory science strategy. There will be ample time for questions and discussion on how the strategy will be implemented and what will be the impact to the healthcare ecosystem as a whole.
- Contribution to HTA’s preparedness and downstream decision making for innovative medicines;
- Bridging from evaluation to access through collaboration with payers;
- Patient relevance in evidence generation;
- High-quality Real World Data (RWD) in decision making;
- Network competence and specialist collaborations to engage with big data.
Who should attend?
- Prepare value dossiers
- Evaluate and prepare clinical narrative for HTA bodies or payers
- HTA policy leads
- Are involved in regulatory strategies
- Collect and disseminate regulatory intelligence
- Work with regulatory science in academia, industry or governmental institution
- Lead scientific advice or early access programmes
- Design real-world evidence studies
- Lead patient engagement
- Work with HCP communication and labelling
What will you get from this event?
- An overview of the priorities of European Regulators, following the “EMA Regulatory Science to 2025” publication and public consultation;
- Insights into the perspective from other stakeholders and how they will partner with regulators to advance the topics promoted by the regulatory science strategy;
- Participate on the discussion on how the “EMA Regulatory Science to 2025” strategy will be implemented;
- Meet Health Authorities, HTA bodies and Industry representatives leading the implementation of the strategy and related collaborations.
Virginia Lee Acha, PhD, MSc • AVP, Global Regulatory Policy
MSD, United Kingdom
Niklas Hedberg, MPharm • Chair EUnetHTA Executive Board, Chief Pharmacist
Dental and Pharmaceutical Benefits Agency, TLV, Sweden
Anthony Humphreys, MPharm • Head of the Regulatory Science and Innovation Task Force
European Medicines Agency, Netherlands
Susan Longman • Head Regulatory Affairs Region Europe
Novartis Pharma AG, Switzerland
Elena Popa, MPharm • Scientific Program Manager