Pharmaceutical Industry Articles & Reports - Page 11

Learn how Veeva's Label Concept Tracking in Vault RIM automates pharmaceutical labeling, manages local deviations, and replaces error-prone country tracker spre

Who owns pharmaceutical proofreading? This analysis explores the roles of artwork, regulatory, and QA teams in the pharma labeling workflow to prevent costly er

Learn the end-to-end pharmacovigilance process for translating safety signals into drug label updates. This guide explains CCDS and how Vault Signal accelerates

Explore the career path from a Regulatory Affairs Generalist to a specialized Labeling Strategist. Learn the key skills, role differences, and industry trends.

A guide to the Target Product Profile (TPP), a strategic document for drug development. Learn its components, purpose, and how to align it with the final drug l

Learn how Veeva RIM automates end-to-end pharmaceutical labeling. This guide explains 5 core workflows for label change management and regulatory compliance.

Get a 6-month checklist for pharmaceutical labeling operations. This guide covers key steps for regulatory approval, FDA/GMP compliance, and avoiding costly del

Learn how Veeva PromoMats' Auto-Update Anchors feature automates marketing claims substantiation to ensure regulatory compliance and reduce manual MLR review ef

A guide to Reference Safety Information (RSI) in clinical trials. Learn the regulatory framework, common pitfalls, and how to avoid SUSAR reporting errors.

Learn why Structured Product Labeling (SPL) is replacing PDF for pharma labeling. This guide explains the FDA mandate, XML standards, and how SPL ensures data i

Explore the regulatory process for negotiating an FDA boxed warning on drug labeling, from initial NDA review to post-market Safety Labeling Changes (SLCs).

Learn to write the Highlights of Prescribing Information (HPI). This guide covers FDA labeling requirements, the Physician Labeling Rule (PLR), and best practic

Learn how the FDA's PLLR replaced old pregnancy categories. This guide explains how to draft clear pregnancy risk summaries for complex biologics with limited d

This comprehensive 2025 guide details e-labeling (e-IFU) regulations worldwide. See our country-by-country analysis of QR code acceptance for medical devices &

An evidence-based review of NLP in regulatory labeling. Learn how AI assists medical writers in drafting Prescribing Information (PI/SmPC) and its limitations.

A comprehensive guide to transitioning from XML-based SPL to HL7 FHIR for e-labeling. Learn the key benefits, regulatory requirements, and steps for team readin

Learn the FDA regulations for off-label promotion and how MSL teams can maintain compliance. This guide covers USPI boundaries and best practices for scientific

Learn how simple pharmaceutical translation errors in an SmPC or patient leaflet can lead to major drug recalls, regulatory sanctions, and patient safety risks.

Explore a structured cascade model for rolling out pharma safety labeling updates to global affiliates, ensuring regulatory compliance and sub-90-day implementa

An analysis of Google's Gemini 3 AI for healthcare, pharma, and biotech. Learn about its multimodal reasoning, agentic features, and applications in drug discov

Learn the difference between a Company Core Data Sheet (CCDS) and local labels. Explore strategies for managing global labeling deviations for regulatory compli

Learn the definitions and key differences between basket, umbrella, and platform trials. This guide explains how master protocols work in precision oncology.

Learn the key differences between ISO 14155 for medical device trials and ICH GCP for pharma. This guide compares their scope, risk management, and regulatory c

An in-depth guide to adaptive trial design. Learn how prespecified changes based on interim data can make clinical trials more efficient and ethical.