Regulatory Affairs
Understanding the Common Technical Document (CTD) Structure for Global Regulatory Submissions
An explanation of the 5 modules of the ICH Common Technical Document (CTD) format required for global drug marketing authorization applications.
Regulatory Affairs
Navigating Global Price Controls: How the US Inflation Reduction Act and Evolving EU Policies Shape R&D in 2026
As global health systems enforce tighter pricing controls under the US IRA and EU health technology updates, biopharma majors are restructuring their R&D portfolios to manage clinical risks.
Regulatory Affairs
Data Integrity in the Pharmaceutical Quality Control Laboratory: ALCOA+ Principles Explained
An educational review of data integrity requirements in pharma QC, covering ALCOA+ principles, audit trails, and data security.
Regulatory Affairs
Out of Specification (OOS) Investigations: Step-by-Step Root Cause Analysis and CAPA Guidelines
A structured tutorial on handling quality control laboratory OOS results, conducting Phase I/II investigations, and implementing corrective actions.
Regulatory Affairs
Therapeutic Hotspots of 2026: Evolving Pipelines in Antibody-Drug Conjugates (ADCs) and GLP-1 Obesity Platforms
Global research pipelines and venture capital inflows are concentrating in targeted cancer therapy with ADCs and next-generation cardiometabolic GLP-1 oral weight-loss compounds.
Regulatory Affairs
Computer Systems Validation (CSV): Implementing the GAMP 5 Lifecycle Framework in Modern Plants
A guide to validating computerized lab and production systems using the GAMP 5 V-model lifecycle, risk assessments, and electronic records compliance.
Regulatory Affairs
B2B Scaling Roundtable: Fieldfisher to Host Dublin Tech Founders on July 1st
Legal firm Fieldfisher will host a scaling roundtable for B2B founders and sales leaders in Dublin on July 1st, featuring legal guidance from Jamie Woodcock and leadership coaching from Fergus McFadden.
Regulatory Affairs
Addiction Counsellors of Ireland Launch Strategic Plan 2026-2029 to Prepare for CORU Regulation
Presented at the ACI’s Annual General Meeting in Carlow by Minister Jennifer Murnane O’Connor and ACI Board member John Devlin, the new three-year strategy focuses on workforce recognition, professional development, and regulatory transitions.
Regulatory Affairs
Ireland Family Reunification 2026: The Complete Guide to Financial Thresholds, Waiting Periods, How to Apply, and What Every Sponsor Must Know
A detailed, practical guide to Ireland's Non-EEA Family Reunification Policy as updated in 2026. Covers the new financial thresholds for all sponsor categories, country-specific waiting periods, step-by-step application process, and a comprehensive pre-application checklist - essential reading for pharmacists, healthcare workers, and life science professionals bringing family to Ireland.
Regulatory Affairs
UK Looks to Spain’s "Catalonia Blueprint" to Boost Global Clinical Trials Competitiveness
As global competition intensifies, UK life sciences leaders are examining Spain’s thriving Catalonia region for strategies to attract commercial sponsors, streamline regulatory reviews, and revitalize Britain’s clinical trials sector.
Regulatory Affairs
Pharmaceutical Regulatory Update 2026: EU, UK, FDA & Global Changes Explained
A massive wave of regulatory reform is sweeping the global pharma industry in 2026. From the EU's most significant legislative overhaul in decades to the FDA's sweeping Operation TrialBlazer, we break down what quality, manufacturing, and regulatory teams need to know to stay compliant.
Regulatory Affairs
Eli Lilly Adapts Direct-to-Patient Model for UK Market with LillyDirect Launch
Eli Lilly has successfully brought its LillyDirect service to the UK. Adapted to comply with strict local regulations, the service partners with regulated healthcare organizations to offer secure, anti-counterfeit delivery of high-demand therapies like Mounjaro directly to patients' doors.