EU Clinical Trial Regulation 536/2014: Compliance, Implementation & Best Practices Training (November 25, 2025)

Core Insights - The training course on "EU Clinical Trial Regulation 536/2014" aims to provide comprehensive knowledge on compliance, implementation, and best practices for conducting clinical studies in the EU [1][2][4] Regulatory Framework - The course covers the requirements for conducting clinical studies under the EU Clinical Trial Regulation, including updates on EU-GCP and the new EU Pharmacovigilance Directive [2][3] - It discusses various licensing methods for Drugs, Biologics, and Combination Products, detailing the regulatory agencies' structure at the EU level and across Member States [3][4] Learning Objectives - Attendees will gain insights into the interaction between the EU and individual countries, registration procedures, and the impact of regulations on product development strategies [4][6] - The course aims to equip participants with strategies for streamlining the registration application process and understanding the concerns of European regulatory personnel [6][8] Key Topics - The training includes sessions on the new EU Regulation 536/2014, risk management in drug development, and the clinical trials application process [7][9] - Specific topics also cover investigational medicinal products (IMPs) and required documentation for compliance [9] Target Audience - The course is designed for a diverse audience, including quality assurance professionals, regulatory affairs experts, clinical operations staff, and investigators [8][10] - It aims to provide practical knowledge for effective trial conduct, submission processes, and compliance considerations [8][11]