- A once|in|a|generation opportunity to optimise regulatory timelines ...🔍
- improving regulatory timelines to optimise patient access to ...🔍
- Improving regulatory timelines to improve patient access🔍
- Generative AI in the pharmaceutical industry🔍
- Best practices for maximizing early|phase trial efficiency to ...🔍
- Optimization of protocol design🔍
- Strategy on Reducing Regulatory and Administrative Burden ...🔍
- Turning EU HTA regulation into a strategic opportunity🔍
A once|in|a|generation opportunity to optimise regulatory timelines ...
A once-in-a-generation opportunity to optimise regulatory timelines ...
A once-in-a-generation opportunity to optimise regulatory timelines to improve time to patient access · The journey of new medicines from the ...
Together, let's change this process and make use of the once-in- a-generation opportunity of the review of. Pharmaceutical Legislation. Because ...
Improving regulatory timelines to improve patient access - Vintura
A once-in-a-generation opportunity ... As the EC is currently considering changes to pharmaceutical legislation as part of the EU pharmaceutical ...
Generative AI in the pharmaceutical industry - McKinsey & Company
The technology could offer pharma companies a once-in-a-century opportunity—but only if they learn to scale it and address the industry's unique ...
Best practices for maximizing early-phase trial efficiency to ... - Parexel
Best practices for maximizing early-phase trial efficiency to accelerate regulatory timelines ... The past few years have presented a range of ...
PRIME: priority medicines | European Medicines Agency (EMA)
PRIME builds on the existing regulatory framework and tools already available such as scientific advice and accelerated assessment. Developers of a medicine ...
Optimization of protocol design: a path to efficient, lower cost clinical ...
As regulatory landscape changes and requirements for safety and efficacy become more stringent, life sciences companies are looking for new ...
Strategy on Reducing Regulatory and Administrative Burden ...
Long timelines combined with limited transparency for stakeholders into aspects of the measure development process can lead to a climate of uncertainty for ...
Turning EU HTA regulation into a strategic opportunity
Challenges and uncertainties arising from EU HTA · Uncertainty around evidence requirements for JCA · Tight timelines for dossier preparation and ...
Regulatory Pathways Supporting Expedited Drug Development and ...
A transformation of the current sequence of regulatory submissions, favouring those countries/collaborations that are best regulatory equipped to make ...
Transforming evidence generation: How predictive AI can optimize ...
Throughout the product development and post-approval lifecycle, manufacturers are inundated with vast amounts of real-world data (RWD), with a promise of ...
Health and bioscience review - Regulatory Roadmap - Canada.ca
The Health and Biosciences Sector Regulatory Review Roadmap outlines Health Canada's plan to address the issues, irritants, and bottlenecks identified by ...
Realizing the promise of Project Optimus: Challenges and emerging ...
Drug development is a highly dynamic process, and questions related to dose selection and optimization evolve with the different goals and ...
Reregulation and the Regulatory Timeline | Iowa Law Review
of regulation, one regulatory approach might structure the initial regulation to maximize the potential for future learning opportunities, which then could.
How to Create a Winning Regulatory Strategy for Your Business
As international and local regulations increase in both volume and stringency, marketing food, drugs, supplements, personal care products, ...
Getting strategic about new-product submissions in the pharma ...
By rethinking the approach to regulatory submissions, pharma companies can reduce timelines and increase their chances of successful product ...
Development programs for CDER- and CBER-regulated drugs and biologics intended to diagnose, treat, or prevent a serious disease or condition where there is an ...
Optimizing Standards for Regulatory Use
ability of a medical device under test to achieve technical goals that are needed to support its intended use. Clinical performance: Conformity ...
Explainer on the Transmission Planning and Cost Allocation Final ...
Timely notice of voluntary funding opportunities and a meaningful opportunity ... optimize the performance of the generation or transmission ...
This compliance guide, prepared with input from regulatory agencies, is designed to be used by agency rule writers and policy analysts as a step-by-step manual ...