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Are timely access and robust safety mutually exclusive?

pharmaphorum

And how can regulators balance timely access with robust safety? A European Federation of Pharmaceutical Industries and Associations (EFPIA) report published earlier this year, for example, compared the timelines of six regulatory agencies between 2011 and 2020. Accelerating safe access.

Safety 88
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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. Meta-analyses contributed least frequently (31.4

Medicine 116
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The Caregiver Vertical: How Pharma Engages

Pharma Marketing Network

Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Findings note that caregivers are a vital source of information. Sunny White. February 2019.

Pharma 98
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Three Steps to Hitting Your MLR Targets in 2021 

Clarify Health

Prior to 2011 when the Affordable Care Act (ACA) was passed, many insurance companies were spending a large portion of premium dollars on administrative costs and profits. Health plans should prioritize high-value providers to include in their network based on case-mix adjusted clinical, quality and cost-efficiency scores.

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Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

7 It is currently being evaluated in a Phase Ib/IIa clinical study, demonstrating to date a good safety profile. While favourable safety has been reported up to the Phase II, the relevance of targeting the C-terminal portion of Abeta still needs to be confirmed.

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UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Legacy MEDSearch

This first-in-female procedure was approved by the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. Food and Drug Administration). “It’s magic,” the patient stated, as the first woman to activate the novel UroActive device.

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Yotam Drechsler & Yaron Segal

Cadensee

Because we see these frequencies as kind of signatures, access codes to different networks that have been impaired in the brain as their own, as described before, and facilitating their recovery. I would love to hear a little bit more about the issue of neural networks and the technology. How does your technology work? Yoav Fisher.