Focus on small molecules
Webcode 26122450
Vitoria Bochner
Parexel International, Rio de Janeiro, BRAZIL
Senior Regulatory Affairs Associate
Vitoria holds a bachelor's degree in pharmacy, from Federal University of Rio de Janeiro, and is currently undergoing a master's program specialized in CMC RA. She has about 5 years of solid experience in Brazil Regulatory Affairs and is specialized on global brands of small molecules/synthetic drugs, along with extensive expertise in marketing authorization transfers of all categories. Vitoria is experienced in CMC dossier creation of post approval variations to be submitted in LATAM markets (exportation products).
Currently Vitoria is allocated in a large molecules CMC project to ensure timely submission of a biological anti-cancer drug in Rest of World countries.
More information please click here.
Julieta Breton
ARGENTINA
Regulatory Specialist 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).
Dr. Carolin Elzer
Boehringer Ingelheim International GmbH, Ingelheim, GERMANY
Global Regulatory Lead CMC Dr Carolin Elzer completed their Diploma studies in Biology at the Ruprechts-Karls-University of Heidelberg, Germany, specializing in molecular biology, cell biology, and biochemistry. She pursued a PhD at the Biochemistry Center in Heidelberg, followed by a postdoctoral research fellowship at the Department of Biochemistry and Molecular Biology in Melbourne, Australia. Transitioning into regulatory affairs, Dr. Elzer served as Senior Manager Regulatory CMC at Pharmalex GmbH for 12 years. Since June 2022, she has held the position of Global Regulatory Lead CMC at Boehringer Ingelheim GmbH, where her primary responsibilities included supporting global CMC maintenance activities for biological and biotech products.
03 - 04/12/2026
03 - 04/12/2026
Day I: 01:00 pm - 5:15 pm CET - Online training
Day II: 01:00 pm - 5:00 pm CET - Online training
You may dial in 30 minutes before the lecture starts
online
online
Event - 1,290€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Event - 1,290€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
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, expectations
Julieta Breton
Dr Carolin Elzer
Coffee break
Vitoria Gomes Bochner
Q&As
End of day I
Recap and outstanding questions of day I
Julieta Breton
Coffee break
Julieta Breton
Dr Carolin Elzer
Recap and outstanding questions
End of online seminar
This seminar can be taken as elective module as part of our qualification program to become a CMC Specialist.
The course concept:
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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.
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