Regulatory Affairs Training

Regulatory Affairs Training

Objective

This training aims to develop the practical knowledge and skills of teams involved in pharmaceutical licensing processes across all stages, from application to renewal, and from transfer to variation.

📂 Preparing licensing dossiers in e-CTD format
📌 Strategic and technical details regarding the licensing application process
🔄 Key considerations in variation, transfer, and renewal applications

The training is enriched with sample dossiers, common errors encountered, and best practice examples within the framework of current legal regulations.

The objective of the training is to raise qualified experts who can manage this critical process by:

◆ planning accurately,
◆ managing the process effectively from start to finish,
◆ and concluding it successfully with minimum feedback.

Content

✓Prepared within the framework of current regulations and standards.
✓Our training presentations are enriched with videos and visuals.

Assessment and Evaluation

At the end of the training, a short assessment exam is administered to evaluate the extent to which participants have understood the subject.

✓An 80% success rate is required for the participation to be considered valid.
✓If this rate is not achieved, the training is offered again free of charge.

This evaluation is conducted both to measure the level of knowledge and to complete the learning process by identifying any points that remain unclear.

Because a robust pharmacovigilance system begins with robust knowledge.

Certificate of Participation

Participants who successfully complete the training are issued a certificate of participation by PharmaSoft İlaç Bilişim Danışmanlık Hiz. Ltd. Şti.

This document demonstrates that the individual has attended the training program and successfully completed its content.

Master the Regulatory Affairs Processes!

• A holistic approach to licensing, variation, and license renewal processes
• Content based on current legislation and Ministry practices
• Real-world examples and application-oriented approach
• Knowledge set for managing processes more accurately, controllably, and effectively

Our Past Trainings

Online CTD Dossier Preparation and Regulatory Affairs Processes Training

Due to high interest and demand, the fourth edition of the Online CTD Dossier Preparation and Regulatory Affairs Processes Training organized by PharmaSoft ACADEMY has been scheduled for Saturday based on participant requests, and pre-registration is now open!

📅 Training Date: June 12, 2026 Friday 🕘 Time: 09.00 – 15.30 💻 Format: Live Online Training 📜 Participation: Certificate of Participation Included 💰 Fee: 5,500 TL (VAT included)

Trainer

Burcu KOYUNCU, a sector professional with 17 years of experience in Regulatory Affairs.

Training Program

Session I (09.15 – 10.15)

General Information on Regulatory Affairs · Current Legislation · 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 Information on CTD Dossiers · Preparation & Organization of CTD Dossiers

Session IV (14.15 – 15.00)

e-CTD Submission

Q&A (15.15 – 15.30)

🎯 Learning Outcomes

  • Mastery of regulatory processes and current legislation
  • Ability to correctly structure CTD dossier architecture
  • Practical experience in e-CTD submission steps
  • Prevention of common errors in marketing authorization dossiers
Variation Application Training for Medicinal Products for Human Use

Make a difference with correct classification in variation processes! Manage your applications more controllably and quickly.

📅 Training Date: March 12, 2026 🕘 Time: 09.00 – 12.00 💻 Format: Live Online Training 📜 Participation: Certificate of Participation Included 💰 Fee: 4,500 TL (VAT included)

Training Program

Session I (09.15 – 10.15)

General Information on the Regulation and Guideline for Variations in Medicinal Products for Human Use

Session II (10.30 – 11.30)

Applied Variation Application Examples

Session III (11.30 – 12.00)

Common Mistakes & Q&A

Trainer

Burcu KOYUNCU, a sector professional with 17 years of experience in Regulatory Affairs.

🎯 Learning Outcomes

  • Ability to distinguish between variation types (Type IA, Type IB, Type II, Extension)
  • Correctly assessing the variation scope of changes
  • Performing variation classification in accordance with legislation and Ministry practices
  • Identifying the sections to be updated in the CTD dossier accurately and completely
  • Recognizing common variation errors and reasons for rejection
  • Reducing time and cost loss through correct classification
  • Developing variation strategies for fast and smooth approval
  • Managing variation applications end-to-end with more control
Marketing Authorization Renewal and PBRER (PYRDR) Preparation Training for Medicinal Products for Human Use

Manage marketing authorization renewal and PBRER (PYRDR) processes with confidence! Reduce error risk and comply with Ministry expectations.

📅 Training Date: March 27, 2026 🕘 Time: 09.00 – 14.00 💻 Format: Live Online Training 📜 Participation: Certificate of Participation Included 💰 Fee: 5,500 TL (VAT included)

Trainers

Burcu KOYUNCU, a sector professional with 17 years of experience in Regulatory Affairs.

MSc. Pharm. Rabia Ayşe ÇETİN, PharmaSoft Co-Founder and General Manager, sector professional with over 25 years of experience in Pharmacovigilance and drug safety.

Training Program

Session I (09.15 – 10.00)

Marketing Authorization Renewal Processes, SmPC/PL Updates, Quality Summary

Session II (10.15 – 11.15)

Preparation of PBRER (PYRDR)

Session III (11.15 – 12.00)

Marketing Authorization Renewal Application

Session IV (13.00 – 13.30)

Frequently Asked Questions and Important Considerations

Session V (13.30 – 14.00)

Q&A

🎯 Learning Outcomes

  • Learning legislative requirements and application steps for the renewal process
  • Understanding the product scope, timing, and content of PBRER (PYRDR) reports
  • Planning marketing authorization renewal and PBRER processes in harmony
  • Reducing the risk of incomplete or incorrect applications during dossier preparation
  • Developing timing and strategy appropriate for Ministry expectations
  • Managing processes in a faster, controlled, and sustainable manner
  • Recognizing common implementation errors and practical solution methods