American Lung Association

Improving Pulmonary Hypertension Diagnosis and Care: Lung Association’s Guidance Published in Pulmonary Circulation

Pulmonary hypertension (PH) has a high mortality rate if untreated. Unfortunately, the disease is not consistently diagnosed or treated across the United States. To improve the diagnosis and care of ...
Goldseiten

Surge Copper Advances Berg Toward Pre-Feasibility with Successful 2025 Drilling and Data Validation Program

Surge Copper Corp. is pleased to report results from its 2025 multidisciplinary drilling and field program at the 100%-owned ...

WEBINAR: FDA's 21 CFR Part 11 Add-on Inspections: Address Software That is Supporting the Company's Quality System and CGMP Documentation

Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...

IQ, OQ, PQ in the Verification and Validation Process Training Course: Master V&V Planning Aligned With FDA cGMP, ICH Q-Series, ISO 13485, and ISO 14971 Risk Management (ONLINE ...

Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...
Applied Clinical Trials Online

Clarifying Ownership of IRT Data in Clinical Trials: Distinguishing Investigator-Controlled Data from Sponsor Operational Data

A structured data ownership model—rooted in ICH GCP principles, supported by MHRA and FDA interpretations, and documented in validated system specifications—will enable sponsors to maintain compliance ...
Opinion
PharmiWebOpinion

In Spite of Trump's Marijuana Executive Order, FDA Hemp and Marijuana Botanical Guidance Will Prevail

Will Decide the Future of Cannabinoid Medicine.Why "Full-Spectrum CBD" Narratives Are Collapsing-and Why MMJ International Holdings DRUG Development Strategy Was Right All Along" stated Duane Boise, ...