Estefanny K. Da Silva N.
Boehringer Ingelheim International GmbH, Barcelona, Spain
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.
Vitor Kenzo Kimura
PAREXEL International, São Paulo, Brazil
Regulatory Affairs Consultant
Ana Terra Dos Santos Macedo
PAREXEL International, São Paulo, Brazil
Regulatory Affairs Consultant
21. - 22.09.2022
21. - 22.09.2022
Day I: 01:00 pm - 5:00 pm - seminarD...
Day I: 01:00 pm - 5:00 pm - seminar
Day II: 01:00 pm - 5:00 pm - seminar
You may dial in 30 minutes before the training starts.
online
online
Veranstaltung - 1.090,- € zzgl. MwSt.
The fee includes a documentation for download and a certificate.
SPECIAL OFFERS
Online seminar with a focus on: Brazil, Mexico, Argentina, Colombia, Chile, Peru
19. - 20.09.2022, online
Simply register for the seminar "Marketing Authorisation in Latin America" and you will receive a €390 discount on the seminar (€1.400 + local VAT rather than €1.790 € + local VAT) if you book it simultaneously.
1.400,00 €
Stability testing for chemical and biological products 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 €
Data requirements in the EU
, 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 - 1.090,- € zzgl. MwSt.
The fee includes a documentation for download and a certificate.
SPECIAL OFFERS
Online seminar with a focus on: Brazil, Mexico, Argentina, Colombia, Chile, Peru
19. - 20.09.2022, online
Simply register for the seminar "Marketing Authorisation in Latin America" and you will receive a €390 discount on the seminar (€1.400 + local VAT rather than €1.790 € + local VAT) if you book it simultaneously.
1.400,00 €
Stability testing for chemical and biological products 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 €
Data requirements in the EU
, 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 Brazil, Mexico, Colombia, Argentina, Chile and Peru - Register now and participate online! This course may be booked separately or as a module in combination with the 2-day course "Marketing Authorisation in Latin America" (webcode 22092610) (special rate available).
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
This online seminar will be of benefit to all those working in the pharmaceutical industry, particularly CMC and regulatory affairs managers, who are dealing with dossier compilation (quality data/module 3) for regions in Latin America.
The seminar will focus on small molecules.
13:00 Welcome and introduction round
13:15
Ana Terra Dos Santos Macedo
14:00
14:10
Estefanny Da Silva
15:25
Ana Terra Dos Santos Macedo
15:35
Vitor Kimura
16:50
Vitor Kimura
17:00 Q&As and outstanding questions
13:00
Ana Terra Dos Santos Macedo
14:10 Coffee break
14:20
Vitor Kimura
15:50 Coffee break
16:00
Vitor Kimura
16:50 Summary and outstanding questions
17:00 End of the online training course
Combineable with our online training Marketing Authorisation in Latin America. Simply register for the seminar "Marketing Authorisation in Latin America" and you will receive a €390 discount on the seminar (€1.400 + local VAT rather than €1.790 € + local VAT) if you book it simultaneously.
Our online training courses are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live.
Please send us your questions concerning the seminar topics in advance.
We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.
Please send your questions to b.wessels@forum-institut.de
The course "CMC requirements in Latin America" may be booked separately or as a module in combination with the 2-day course "Marketing Authorisation in Latin America" (22092610). A special rate is available.
Overall score of all evaluations in 2021
Five stars on Trustpilot = Excellent
An online seminar to discuss real cases/challenges for marketing authorisation in Mexico, Argentina, Colombia, Peru, Chi...
Dieses Seminar macht Sie regulatorisch fit in Sachen Packungsbeilage, Artworkmanagement und Qualitätskontrolle/Audit/Ins...
In diesem Seminar erhalten Sie Know-how zur Zulassung von Arzneimitteln in Europa. Sie lernen, welche Zulassungswege mög...
The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity f...
In 2 Lehrgangstagen erhalten Sie profundes gesundheitspolitisches und gesundheitsökonomisches Know-how sowie Praxiswisse...
Many abbreviations are used in all regulatory areas. Download the list of the most important ones.
Details