Announcements

PharmaSoft ACADEMY’s online training programs for the final quarter of the year begin with one of the most popular topics in the industry: Online CTD Dossier Preparation and Marketing Authorization Processes Training. Following the strong interest shown in our previous training programs, our program focusing on CTD and marketing authorization processes is returning for the new season. 📅 Training Date: 20 October 2026, Tuesday 🕘 Time: 09:00 – 15:30 💻 Format: Live Online Training 📜 Participation: Certificate of Participation 💰 Fee: 7500 TL (VAT included) Trainer With more than 18 years of industry experience in Regulatory Affairs, Burcu KOYUNCU will combine theoretical knowledge with practical, real-life examples throughout the training. Training Program Session I (09:15 – 10:15) General Overview of Marketing Authorization · Current Regulatory Requirements · Marketing Authorization of Medicinal Products for Human Use Session II (10:30 – 12:00) Marketing Authorization of Medicinal Products for Human Use (Continued) Session III (13:00 – 14:00) General Overview of the CTD Dossier · Preparation and Organization of the CTD Dossier Session IV (14:15 – 15:00) eCTD Submission Q&A Session (15:15 – 15:30) 🎯 Learning Outcomes Up-to-date knowledge of regulatory requirements related to marketing authorization processes A comprehensive understanding of the marketing authorization process for medicinal products for human use Ability to structure a CTD dossier accurately and effectively Understanding of the key steps involved in the eCTD submission process Ability to identify common errors and critical points in submission dossiers in advance A more systematic and controlled approach to managing regulatory affairs processes