- Online training -
Webcode 24122450
Estefanny K. Da Silva N.
Boehringer Ingelheim International GmbH, Frankfurt, GERMANY
Global Manager of CMC Regulatory Affairs Estefanny K. Da Silva N. is a Pharmacist by training. She has 10 years of local, regional and global experience in Regulatory Affairs working for multinational companies with pharmaceuticals, biotechnological products and medical devices.
Ana Terra Dos Santos Macedo
PAREXEL International, São Paulo, BRAZIL
Regulatory Affairs Consultant Ana Terra dos Santos Macedo has more than 13 years of experience in Regulatory Affairs, involving regulatory cycle of products, since the evaluation of the feasibility of new products, marketing application strategy, certification of good manufacturing practices, to the maintenance of the products through the critical evaluation, classification and proper submission of variations in accordance with the current regulations. Currently Ana Terra is responsible of Marketing Authorisation submissions and maintenance of wide portfolio of products in the International division (LATAM Region).
Julieta Breton
PAREXEL International, Buenos Aires, ARGENTINA
Associate at Regulatory Affairs Julieta Breton has 10 years of experience in the pharmaceutical industry, involving in activities related to quality control, R&D, pharmacovigilance and regulatory affairs. She has strong experience in preparation of marketing authorization applications for medicinal products, and activities related with the pharmaceutical industry as new sites of authorization and product variations. Currently Julieta is responsible of MA submissions and maintenance of wide portfolio of products in the International division (LATAM and Central American Region).
10-11/12/2024
10-11/12/2024
Day I: 01:00 pm - 5:15 pm - seminar
Day II: 01:00 pm - 5:00 pm - seminar
You may dial in 30 minutes before the training starts
online
online
Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
SPECIAL OFFERS
e-Learning: CTD Module 3
, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
340,00 €
e-Learning: Stability Testing in the ICH Region
, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
340,00 €
Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
SPECIAL OFFERS
e-Learning: CTD Module 3
, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
340,00 €
e-Learning: Stability Testing in the ICH Region
, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
340,00 €
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
CMC requirements in Latin America with focus Mexico, Brazil, Colombia, Argentina, Chile, and Peru. The seminar (2 half days) is comfortable to integrate into your daily work routine.
During this seminar you will learn about the specific CMC requirements for the different countries in Latin America with a focus on Brazil, Mexico, Colombia, Argentina, Chile and Peru.
Three (local) experts will share valuable information regarding
Welcome, introduction round, expectations
Estefanny K. Da Silva N.
Estefanny K. Da Silva N.
Coffee break
Ana Terra Dos Santos Macedo
Q&As
End of day I
Recap and outstanding questions of day I
Julieta Breton
Coffee break
Julieta Breton
Estefanny K. Da Silva N.
Outstanding questions and conclusion
End of online seminar
You are looking for this topic for several employees?
We offer the right solution at your site or in virtual format!
We also offer this seminar as an in-house seminar.
Take advantage of the proven concepts of our open seminars and bring your employees to the same level of knowledge quickly and easily.
We will be happy to send you a non-binding offer.
FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.
of 5 stars of all ratings from 2023
of 5 stars on Trustpilot = good
This course familiarises you with regulatory post-approval duties and provides first-hand information on variation submi...
Dieses Seminar gibt Ihnen Tipps zur besseren Verfahrensbegleitung im MRP und DCP und zum Lifecycle-Management in Europa
Ein praxisorientiertes Online-Seminar zur effektiven Umsetzung von Labelling-Richtlinien und PV-Vorgaben sowie zur Optim...
Explore the transformative potential of artificial intelligence in pharmacovigilance. This course provides an in-depth u...
Wie werden die aktuellen GDP-Anforderungen in die Praxis umgesetzt? In unserem Seminar & Workshop erhalten Sie pragmatis...
This whitepaper describes what you need to keep in mind when it comes to specific Japanese CMC requirements for marketin...
Details
More than 4,500 customers have rated our training courses. Thank you for awarding us 4.3 stars out of 5.
Details
