- How can health technology assessment be improved to optimise ...🔍
- The challenges of access to innovative medicines with limited ...🔍
- Navigating the PICO Framework in the New EU HTA Regulation🔍
- EFPIA's Regulatory Road To Innovation – Back To The Cutting Edge🔍
- 21st Regulatory Affairs and Pharmacovigilance Virtual🔍
- Federal Register/Vol. 89🔍
- How can we optimise health technology assessment and ...🔍
- Patient Involvement in Regulatory and Health Technology ...🔍
improving regulatory timelines to optimise patient access to ...
How can health technology assessment be improved to optimise ...
'Established ways to deal with uncertainty during HTA' could improve medicines' availability and timeliness, while more 'reliance on real-world ...
The challenges of access to innovative medicines with limited ...
However, rapid access to new medicines from the regulatory side means that in most cases, more uncertainty is accepted at the time of approval, ...
Navigating the PICO Framework in the New EU HTA Regulation - PPD
In this era of change, it is imperative for HTDs to start strategizing now. There are significant opportunities for HTDs to improve patient ...
EFPIA's Regulatory Road To Innovation – Back To The Cutting Edge
EFPIA, Every Day Counts - Improving Regulatory Timelines To Optimise Patient Access To Innovative Oncology Therapies In Europe (2021) https ...
21st Regulatory Affairs and Pharmacovigilance Virtual
... regulatory amendments can deliver better access ... optimise the regulatory processes and deliver on faster patient access to medicines.
Federal Register/Vol. 89, No. 27/Thursday, February 8, 2024/Rules ...
... improve patients' access to timely care. B. Summary of Major Provisions. In the CMS Interoperability and. Patient Access final rule, we ...
How can we optimise health technology assessment and ...
Regulatory approval of a drug does not ensure patient access – there ... bursement organisations, and to suggest ways to improve patient access.
Patient Involvement in Regulatory and Health Technology ... - ISPOR
Integrating these unique insights in decision making helps drive the development of innovative medicines, improve health outcomes, and transform healthcare. For ...
Regulatory Access Pathways to Facilitate Early Access, HTA ...
Many patients with severe illnesses still have no treatment today. Disparities in regulations and timelines have proven to be a real obstacle to the access.
Forging ahead with US and EU healthcare policy changes
Meanwhile, in Europe, the EU Health Technology Assessment (HTA) Regulation is about to be increasingly adopted to streamline and enhance ...
Accelerated and conditional regulatory pathways for drug approvals are intended to enable earlier patient access to potentially life-saving.
Is Treatment Optimization Coming of Age in Europe?
The essence of the concept is conducting clinical research in real-world conditions, to improve the standard of treatment for patients. It can ...
RECOMMENDATIONS FOR IMPROVING ACCESS TO MEDICINES ...
attention to the problem of medicine shortages and inequalities in patient access ... Removing these measures will weaken the regulatory system at ...
EU HTA: Business as usual for market access strategy or time for ...
Public availability of robustly evaluated efficacy and safety data 30 days after EMA marketing authorization may put pressure on payers to ...
to improve patient access to safe, effective, and innovative medicines. While it also acknowledges that the medical devices regulatory environment is ...
EU's Expedited Regulatory Pathways: Latest Insights and ...
These procedures offer numerous benefits, including efficiency, improved planning, transparency, and ultimately faster patient access to ...
EFPIA on X: "For patients, every day counts: how can we improve ...
For patients, every day counts: how can we improve regulatory approval decision timelines to optimise patient access to innovative therapies ...
Accelerated Assessment of ATMPs | EuroGCT
Accelerated assessment is a regulatory tool supported by the EMA to shorten the centralised procedure review period of a marketing authorisation ...
... improve patients' access to timely care. B. Summary of Major Provisions. In the CMS Interoperability and Patient Access final rule, we required impacted ...
Proposed Solutions to Further Improve the Regulatory Landscape ...
On 27 May 2016, the European Medicines Agency (EMA) convened a multi-stakeholder meeting to explore ways to foster Advanced Therapies Medicinal Products (ATMPs) ...