- Online training -
Webcode 23042453
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. Ana Terra is responsible of Marketing Authorisation submissions and maintenance of wide portfolio of products in the International division (LATAM Region).
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.
Julieta Breton
PAREXEL International, Buenos Aires, ARGENTINA
Julieta Breton, Associate at Regulatory Affairs has 10 years of experience in Pharmaceutical Industry, involving in activities related to quality control, R&D, pharmacovigilance and regulatory affairs. 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. Julieta is responsible of MA submissions and maintenance of wide portfolio of products in the International division (LATAM and Central American Region). The gained experience is currently used in the advice and support for submission of MAA, analysis of the documentation for registration purposes, feasibility assessment and regulatory Intelligence reports, and for the preparation of regulatory packages related to clinical Studies, if applicable.
anytime
anytime
19 April, 26 April, 3 May, 10 May, 1...
19 April, 26 April, 3 May, 10 May, 17 May, 24 May 2023 each from 2:00 pm - 4:00 pm CET (= UTC+2) - live webcast
You may dial in 30 minutes before the training starts
online
online
Event - 1,490 € plus tax
The fee includes a documentation for download and a certificate.
SPECIAL OFFERS
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 €
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 €
Event - 1,490 € plus tax
The fee includes a documentation for download and a certificate.
SPECIAL OFFERS
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 €
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 €
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, Peru and CAMCAR (Central America and Caribbean). The webcast format is comfortable to integrate into your daily work routine. You desire to choose only single webcast sessions? Contact us!
During this webcast series you will learn about the specific CMC requirements in Latin America (Mexico, Brazil, Colombia, Argentina, Chile, Peru, CAMCAR).
Three (local) experts will share valuable information regarding
14:00 Welcome, expectations, introduction
14:15
Estefanny Da Silva
15:45 Q&As
16:00 End of webcast
14:00 Welcome and introduction round
14:10
Estefanny Da Silva and Julieta Breton
15:45 Q&As
16:00 End of webcast
14:00 Welcome and introduction round
14:10
Julieta Breton
15:45 Q&As
16:00 End of webcast
14:00 Welcome and introduction round
14:10
Julieta Breton
15:45 Q&As
16:00 End of webcast
14:00 Welcome and introduction round
14:10
Ana Terra Dos Santos Macedo
15:45 Q&As
16:00 End of webcast
14:00 Welcome and introduction round
14:10
Estefanny Da Silva
15:45 Q&As
16:00 End of webcast
You are working with affiliates or external partners in MENA?
Four (local) experts will share their in-depth knowledge on CMC requirements in these regions (focus Levant (Morocco, Tunisia, Jordan, Lebanon, Iraq), GCC, Türkiye, Iran and Egypt) with you - webcasts scheduled weekly in January 2023.
For more information visit our website using the webcode 23012450.
You are working with affiliates or external partners in Asia, Japan or Eastern Europe/EAEU?
Four (local) experts will share their in-depth knowledge on CMC requirements in these regions (focus China, India, Japan and Korea, Russia/EAEU) with you - webcasts scheduled weekly in March 2023.
For more information visit our website using the webcode 23032451.
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
Overall score of all evaluations in 2022
Five stars on Trustpilot = Excellent
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