Focused insights on regulatory strategies in Brazil, Mexico, Argentina, Colombia, Chile and Peru
Webcode 25092510
Anita Patel
Pharmacist and Biochemist, Regulatory Affairs Director, Parexel International, São Paulo, BRAZIL
Pharmacist and Biochemist, Regulatory Affairs Director Anita has thirteen years experience in regulatory affairs consulting and leads the Latin American regulatory and publishing team in Argentina, Brazil, Chile, Colombia, Mexico and Peru. Together with other experts in Latin America, Anita oversees and acts as project lead for regulatory support provided to pharmaceutical companies for the submission of marketing authorisation applications, registration maintenance, marketing authorisation transfers, regulatory strategy for submissions, GAP analyses and regulatory intelligence reports for Latin American countries. Prior to consulting, Anita gained 11 years' experience in regulatory affairs in the Brazilian pharmaceutical industry.
Bertha Cabrera Lavado
Parxel International, Lima, Peru
Associate Director, Regulatory Affairs; With more than 14 years of hands-on experience in the regulatory field within a Contract Research Organisation (CRO), Bertha Cabrera Lavado brings a deep understanding of regulatory processes and compliance requirements. Over the past decade, she has specialised in Regulatory Affairs Consultancy, with a strong focus on the Latin American region. For the past five years, she has successfully led the Americas Clinical Trial Regulatory Service, guiding teams and projects through complex regulatory landscapes. As a Global Regulatory Lead, she has driven clinical trial submissions across Europe, Latin America, and the Asia-Pacific region. Her leadership experience extends across several countries in the Americas, where she has managed cross-functional teams and collaborated with international stakeholders. She is highly proficient in the use of various regulatory platforms and tools, including Veeva, Planisware, Pmed, Trackwise, and Precision. Her expertise covers a broad spectrum of Regulatory Affairs, with a particular emphasis on the LATAM region.
24-25/09/2025
24-25/09/2025
from 10:00 - 18:00 on both days, You may dial in 30 min. before the session
online
online
Veranstaltung - 1,990 € zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Veranstaltung - 1,990 € zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@forum-institut.de
An interactive online seminar to explore real regulatory cases and challenges in marketing authorisation and lifecycle management across Mexico, Argentina, Colombia, Peru, Chile and Brazil - led by local experts from Brazil and Peru.
What are the key success factors in introducing your products in the LATAM region? What do you need to consider when applying for marketing authorisation in countries such as Brazil, Mexico, Argentina or Peru?
This online seminar will equip you with the knowledge to answer these questions.
Two seasoned LATAM experts will guide you through the region’s complex regulatory landscape, offering first-hand insights into dossier requirements, authorisation procedures and maintenance duties.
Through interactive case studies and group discussions, you will explore market-specific challenges and receive practical tools for your day-to-day regulatory work. You’ll also benefit from expert tips on fast-track options, reliance strategies, and dossier format differences.
The combination of theoretical input and practical application ensures a deep understanding of the regulatory affairs business in Latin America - empowering you to develop more effective market access strategies.
Anita Patel
Anita Patel
Anita Patel
All
Bertha Cabrera Lavado
Bertha Cabrera Lavado
Anita Patel
Anita Patel
Bertha Cabrera Lavado
Bertha Cabrera Lavado
Bertha Cabrera Lavado, Anita Patel
Bertha Cabrera Lavado, Anita Patel
Bertha Cabrera Lavado, Anita Patel
Are you interested in an in-house training course on topic "Marketing Authorisation in Latin America"? Please contact us to find out more.
Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.
All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.
On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.
Learn more about our online events here.
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.
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
Overall impression: 100 % of the participants' feedback was very good or good (September 2022)
Course content: 100 % of the participants' feedback was very good or good (September 2022)
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This seminar deals with regulatory aspects in Latin American countries. The seminar is conducted by very experienced speakers from Spain and Brazil. There are practical activities that enable you to deepen the knowledge you have acquired. The seminar left a very positive impression in terms of the knowledge imparted and the technical competence of the speakers.
Both speakers were great!
I wanted to get a comprehensive overview of the regulatory issues in Latin American countries. The seminar exceeded my expectations
Brazil requirements very helpful
Andrea and Esther did a very good Job; I expected an overview about the regulations and specific issues, and I get one.
Specific questions relating to Brazil - expectation met
