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.
MARKETING APPROVAL of MEDICINAL PRODUCTS
octombrie 4 @ 4:00 pm - octombrie 5 @ 8:00 pm
Regulatory procedures & applications
Online Training- Live via Microsoft Teams
4-5th October 2021 /16.00 -20.00 (CEET time)
TOPICS:
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.
SPEAKERS:
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:office@pharmatrained.com
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.
