Numarul  minim de participanti pentru organizarea unei sesiuni de curs este de 15 cursanti. In functie de numarul inscrierilor, data propusa pentru desfasurarea unui training poate suferi modificari.

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  • Acest eveniment a trecut.


18 noiembrie 2021 @ 4:00 pm - 19 noiembrie 2021 @ 8:00 pm

Regulatory procedures & applications

Online Training- Live via Microsoft Teams
18-19th November, 2021 /16.00 -20.00 (CEET time)


This training are including some of the Essential theoretical and practical Regulatory Technical knowledge for a Regulatory Affairs Professional, regarding Regulatory procedures & applications:

  • Documentation structure and regulatory requirements for different registration application types. Well-established use
  • CTD file structure; Non-clinical overview Module 2 preparation
  • Registration and maintenance procedures during the life cycle of medicinal products:
  • Type and eligibility of procedures: Centralized, DCP, MRP, National.
  • Role of competent authorities
  • EU Applicable Legislative framework


Important aspects related to the course: Interactive sessions. Case studies.

Audience: This course is intended for regulatory affairs staff (beginners and experienced) who are willing to progress in own career path, exchange knowledge and experience with peers, and build a personal network.


 Katja Pečjak/Slovenia (Katja Pecjak | LinkedIn)

 Jana Brajdih Čendak/Slovenia (Jana Brajdih Cendak | LinkedIn)

Elena Georgescu/Romania (Elena Georgescu | LinkedIn)

To participate in the course, click the „Register” button, download the Registration Form, and send it completed and signed to the


The maximum number of participants for organizing a course session is 15 students. Depending on the number of registrations, the proposed date for conducting a training may change.


18 noiembrie 2021 @ 4:00 pm
Se termină:
19 noiembrie 2021 @ 8:00 pm

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