Role of innovation in pharmaceutical regulation: A proposal for principles to evaluate EU General Pharmaceutical Legislation from the innovator perspective.

Because the EU General Pharmaceutical Legislation is under review, the EFPIA Innovation Board developed evaluation principles for the policy proposals and key considerations on how the regulatory framework can support innovation while ensuring only safe, efficacious and quality medicines are authorized. The evaluation principles are anchored on actions to promote: agile adoption of new methodologies with soft law tools; continued emphasis on regulatory science to inform policies; a cost/benefit assessment of the new regulation to ensure they have an overall positive impact; and mitigation of any negative externalities or unintended effects for any type of innovation or products. The evaluation principles are intended to guide the impact assessment of the pharmaceutical legislation in the EU but the principles can be applied globally.

Toward A Regulatory Pathway for the Use of in Silico Trials in the CE Marking of Medical Devices.

In Silico Trials methodologies will play a growing and fundamental role in the development and de-risking of new medical devices in the future. While the regulatory pathway for Digital Patient and Personal Health Forecasting solutions is clear, it is more complex for In Silico Trials solutions, and therefore deserves a deeper analysis. In this position paper, we investigate the current state of the art towards the regulatory system for in silico trials applied to medical devices while exploring the European regulatory system toward this topic.

Optimization of the Photon Path Length Probability Density Function-Simultaneous (PPDF-S) Method and Evaluation of CO₂ Retrieval Performance Under Dense Aerosol Conditions.

The photon path length probability density function-simultaneous (PPDF-S) algorithm is effective for retrieving column-averaged concentrations of carbon dioxide (XCO₂) and methane (XCH₄) from Greenhouse gases Observing Satellite (GOSAT) spectra in Short Wavelength InfraRed (SWIR). Using this method, light-path modification attributable to light reflection/scattering by atmospheric clouds/aerosols is represented by the modification of atmospheric transmittance according to PPDF parameters. We optimized PPDF parameters for a more accurate XCO₂ retrieval under aerosol dense conditions based on simulation studies for various aerosol types and surface albedos.

Diagnostic Value of Combined Acute Levodopa Challenge and Olfactory Testing to Predict Parkinson's Disease.

Background: The diagnosis of Parkinson's disease (PD) can be challenging early in the disease course, when motor features are subtle. The objective of this study was to explore the diagnostic value of combining acute levodopa challenge and olfactory testing to predict PD.

Methods: Data from 210 patients with a recent onset of parkinsonism who had at least 2 years of follow-up and underwent acute levodopa challenge for the clinical prediction of long-term dopaminergic response and had olfactory testing with Sniffin' Sticks Test were evaluated.