Global CMC requirements: focus on Latin America/Latam countries
Focus on small molecules
- Experts with local know-how
- Practical activity after each lecture
- Inform us about your most relevant countries/regions
- Officially certified according to ISO 9001 and ISO 21001
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
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
Booking details
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
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
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.
Your speakers
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…
Your speaker
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.
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…
Your speaker
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,…
Your speaker
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.
What to Expect
- Adaptation from EU and differences within Latam (Latin America)
- CMC requirements in Brazil, Mexico, Colombia, Argentina, Chile, Peru: Documentation, country specific requirements, post-approval activities, future trends in the regions
Who Should Attend
This 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.
Objective of the Event
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
- pharmaceutical documentation;
- country specific requirements;
- post-approval activities and
- future trends.
After the training course you will have gained a better understanding of the additional and differing CMC related requirements and procedures in the different regions.
Your Benefit
- Meet three (local) experts that will share in-depth knowledge with you!
- Obtain practical CMC know-how for emerging markets!
- Integrate the two half days conveniently into your daily work routine!
- Make profit from the practical activity after each talk ("easy learning through application")!
Here are some "voices" of participants from last year's course:
- "A successful and informative event that I really enjoyed"
- "Very detailed documentation"
- "Practical approach, very useful, possibility to ask specific questions"
- "Very good and commprehensive overview."
- "Very interesting seminar, very helpful, thank you"
Programme
Day 1: 1:00 pm - 5:15 pm
Day 2: 1:00 pm - 5:00 pm
Day 1
Julieta Breton
- Overview of the Latam Region
- Adaptation from EU and differences within LatAm
Dr Carolin Elzer
- Pharmaceutical documentation
- Additions and differences with regard to ICH requirements
- Country specific requirements
- Practical experiences (e.g. MAA, renewal, variations)
- Avoiding typical mistakes in the dossier, common pitfalls
- Lifecycle management: Post-approval changes. Standards in the ICH region, Additional and differing procedures/documentation in Mexico
- Future trends
- Practical activity
Vitoria Gomes Bochner
Same content as lecture on Mexico.
Welcome, introduction, expectations
Latam Overview
Latam Overview
Julieta Breton
- Overview of the Latam Region
- Adaptation from EU and differences within LatAm
CMC requirements in Mexico
CMC requirements in Mexico
Dr Carolin Elzer
- Pharmaceutical documentation
- Additions and differences with regard to ICH requirements
- Country specific requirements
- Practical experiences (e.g. MAA, renewal, variations)
- Avoiding typical mistakes in the dossier, common pitfalls
- Lifecycle management: Post-approval changes. Standards in the ICH region, Additional and differing procedures/documentation in Mexico
- Future trends
- Practical activity
Coffee break
CMC requirements in Brazil
CMC requirements in Brazil
Vitoria Gomes Bochner
Same content as lecture on Mexico.
Q&As
End of day I
Day 2
Julieta Breton
- Pharmaceutical documentation
- Additions and differences with regard to ICH requirements
- Country specific requirements
- Practical experiences (e.g. MAA, renewal, variations)
- Avoiding typical mistakes in the dossier, common pitfalls
- Lifecycle management: Post-approval changes. Standards in the ICH region, Additional and differing procedures/documentation in Mexico
- Future trends
- Practical activity
Julieta Breton
Same content as lecture on Argentina and Chile.
Dr Carolin Elzer
Same content as lecture on Argentina and Chile.
Recap and outstanding questions of day I
CMC requirements in
Argentina and Chile
CMC requirements in Argentina and Chile
Julieta Breton
- Pharmaceutical documentation
- Additions and differences with regard to ICH requirements
- Country specific requirements
- Practical experiences (e.g. MAA, renewal, variations)
- Avoiding typical mistakes in the dossier, common pitfalls
- Lifecycle management: Post-approval changes. Standards in the ICH region, Additional and differing procedures/documentation in Mexico
- Future trends
- Practical activity
Coffee break
CMC requirements in Peru
CMC requirements in Peru
Julieta Breton
Same content as lecture on Argentina and Chile.
CMC requirements in Colombia
CMC requirements in Colombia
Dr Carolin Elzer
Same content as lecture on Argentina and Chile.
Recap and outstanding questions
End of online seminar
Downloads
Request the documents using our form.
Abbreviations_Drug Regulatory Affairs and CMC
Weitere Informationen
Modular qualification course CMC Specialist
This seminar can be taken as elective module as part of our qualification program to become a CMC Specialist.
The course concept:
- You attend our basic course "CMC Management in Regulatory Affairs"
- Then you choose and take part in 3 further seminar modules (= 3 seminar days), which you put together individually from the course plan.
- You receive structured further training and comprehensive knowledge in CMC-relevant topics.
- You can specialise according to your main area of business activity by selecting the seminars specifically.
For more information, please visit our Website
In-house seminars: Advanced training tailor-made!
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.
Benefits of a FORUM Institut training course
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.
- Live and interactive learning on our Learning Space training platform
- A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
- Easy surveys with Slido
- ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
- A central repository for documents and media
- Other services and apps such as Padlet and Mentimeter available directly on the platform
- The perfect marriage of teaching methods and technology
- High level of interactivity with plenty of opportunity for questions
- Continuous support throughout the event to ensure the most effective learning
- Free technical pre-meeting to start off your training on the right foot
Free pre-meeting and technology check
You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.
The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.
Our Recommendations
Further Information
Your Contact Person
We are happy to advise you personally and individually.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de