Pharmaceutical Industry Articles & Reports - Page 24

An educational guide comparing the EU Risk Management Plan (RMP) vs. the US REMS for drug safety. Learn about key differences in scope, content, and triggers.

Learn to implement an audit-ready ISO 27001 ISMS for life sciences. This guide covers integrating cybersecurity with GxP, QMS, and FDA regulatory compliance.

Learn the key differences between LIMS, ELN, SDMS, and CDS. This guide explains the purpose, features, and use cases for each lab informatics system.

A clear comparison of the DSUR vs. the PSUR/PBRER. Understand the distinct purpose, scope, timing, and governance of these key pharmacovigilance safety reports.

Learn about patient support hub programs in specialty pharma. This guide covers key workflows, technology, data management, and compliance for improving drug ac

An in-depth guide to HTA dossiers. Explore the evidence requirements, economic models, and submission templates for NICE (UK), CADTH (Canada), and ICER (US).

An in-depth guide to the ICH E2B(R3) standard for pharmacovigilance. Explore the data structure of ICSRs, electronic reporting rules, and key global systems. Updated April 2026.

Compare CareMetx, AssistRx, PHIL, and Lash Group (Cencora) patient hub platforms in 2026 — covering technology, services, performance metrics, and the impact of IRA Part D reforms and the Medicare Drug Price Negotiation rollout.

Analyze leading pharmaceutical artwork management systems. This guide compares Esko, Kallik, and Blue Software for pharma label compliance, workflows, and audit

Choosing a GxP ELN? Compare Benchling, IDBS, and LabArchives on features for 21 CFR Part 11 compliance, system validation, and ALCOA data integrity principles.

Learn the compliant process for answering off-label HCP inquiries. This guide details FDA guidance, medical information SOPs, and software for case management.

Learn how pharma firms use competitive intelligence software to mitigate patent cliff risks. Updated April 2026 with the Humira/CVS Caremark biosimilar shift, Stelara LOE, and AI-native CI platforms.

Efficacy in clinical trials often overstates real-world effectiveness. Learn why this gap exists and how HEOR uses real-world evidence (RWE) to correct for it.

Outcomes-based drug contracts and the IT/data infrastructure needed to track real-world patient outcomes. Updated April 2026 with CMS Multiple Best Prices, CGT Access Model, and IRA impacts.

An educational guide to QALYs and ICERs, the core metrics in health economics. Learn how they measure value and guide cost-effectiveness decisions. Updated April 2026 with NICE's new £25k–£35k/QALY threshold.

An in-depth comparison of ICER (US) vs NICE (UK). Explore their methods, QALY thresholds, and how they assess drug value to influence global pricing floors.

Learn what must be included in a pharma quality agreement. This 2026-updated guide covers key clauses, sponsor vs. CDMO responsibilities, and GMP regulatory requirements including FDA 2016 guidance, EU GMP Annex 1 (2023), ICH Q9(R1), and DSCSA.

Learn the fundamentals of pharmaceutical stability programs. Covers study design, execution, and data trending per the new consolidated ICH Q1 (2024) and FDA guidelines.

Understand analytical method validation with this deep dive into ICH Q2(R2). Explore validation parameters, documentation, and the new QbD lifecycle approach wi

Lifecycle approach to biotech process validation: PPQ and CPV planning, execution, and monitoring under FDA, EMA Annex 1/15, ICH Q9(R1), Q12, and Q13 guidance.

An educational guide to generic drug patent challenges. Learn about the Hatch-Waxman Act, the ANDA pathway, Paragraph IV certifications, the FDA Orange Book, FTC delisting actions, and the 2024 Teva v. Amneal Federal Circuit ruling.

Learn how pharma companies compliantly fund physician education via unrestricted grants. Explore ACCME standards, the Sunshine Act, and firewalls for ethical CM

Learn how Process Analytical Technology (PAT) uses sensors like NIR & Raman for real-time reaction monitoring in pharmaceutical manufacturing to improve quality

Learn how Quality by Design (QbD) and IT systems are shifting pharma from end-product testing to real-time quality assurance with PAT and data analytics.