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.
- Acest eveniment a trecut.
MARKETING APPROVAL of MEDICINAL PRODUCTS
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 address:firstname.lastname@example.org
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.