Online Regulatory Affairs Training
Date: October 23 – 24, 2025
Time: 09:00 – 16:00
Duration: 2 Days | 14 Hours Total
Format: Live Online Training
Certificate: Certificate of Attendance
Fee: 7,000 TL (VAT included)
Trainer Information
The training will be delivered by Burcu KOYUNCU, a regulatory affairs professional with 17 years of industry experience.
Training Objective
To provide participants with a comprehensive overview of the regulatory processes for human medicinal products, current legislation, CTD structure, and the Electronic Submission System.
The training also aims to highlight common mistakes in practice and provide practical tips.
Training Program
Day 1 – Regulatory Affairs for Human Medicinal Products
- Overview of regulatory affairs and legislation
- Regulation on the Licensing of Human Medicinal Products
- Process flows and application steps
- Summary, evaluation, and Q&A
Day 2 – Preparing CTD Files and Using Electronic Submission System
- Overview of CTD structure
- CTD Modules 1, 2, 3, 4, 5
- Using Electronic Submission System: e-CTD Applications, General Documentation Submissions, Variation Applications, Incoming–Outgoing Correspondence Tracking
- Summary, evaluation, and Q&A
Learning Outcomes
- Advanced understanding of regulatory processes and current legislation
- Proficiency in CTD structure
- Ability to upload and review applications in the Electronic Submission System
- Skills to prevent common mistakes in regulatory files
Who Should Attend?
- Professionals working in regulatory affairs
- Newcomers to the pharmaceutical industry
- Individuals aiming for a career in regulatory affairs
- Students in pharmacy, chemistry, biology, or related fields
Additional Information
- The training language is Turkish.
- Seats are limited.
👉 For detailed information and registration: business@pharmasoft.com.tr
Regulatory Affairs
Training
- OBJECTIVE
- CONTENT
- ASSESSMENT AND EVALUATION
- CERTIFICATE OF PARTICIPATION
This training is designed to enhance the practical skills and regulatory insight of professionals involved in the pharmaceutical licensing process — covering every step from initial application to renewal, transfer, and variation procedures.
📂 Preparing regulatory dossiers in e-CTD format
📌 Strategic and technical considerations in marketing authorization applications
🔁 Key points in variation, renewal, and license transfer submissions
The program is enriched with real-life case examples, common pitfalls, and best practices, all aligned with current regulatory frameworks.
The ultimate goal is to equip participants to:
🔹 plan regulatory processes with precision,
🔹 manage each phase effectively,
🔹 and successfully complete submissions with minimal feedback —
becoming confident, competent experts in regulatory affairs.
Training Content
✅ The training content has been prepared within the framework of the current regulation and standards.
✅ Our training presentations were enriched with videos and images.
Assessment & Evaluation
At the end of the training, participants take a brief assessment to evaluate their understanding of the content.
✅ A minimum score of 80% is required for successful completion.
✅ Participants who do not meet this threshold are offered a free repeat session.
This assessment is designed not only to measure knowledge, but also to identify areas that may need reinforcement — helping ensure learning is complete and effective.
Because a strong pharmacovigilance system starts with strong knowledge.
Certificate of Participation
A Certificate of Participation is issued by
PharmaSoft Ilac Bilisim Danismanlik Hiz. Ltd. Sti.
to participants who successfully complete the training.
The certificate confirms the participant’s completion of the program and their active engagement with the training content.
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☎ +90 216 326 77 12
📠 +90 216 428 39 71
📧 info@pharmasoft.com.tr
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