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.

✅ The training content has been prepared within the framework of the current regulation and standards.

✅ Our training presentations were enriched with videos and images.

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.

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.