Navigating from CTD to eCTD: A Comprehensive Two-Day Workshop for Brazil, Day I
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10:00-12:00 AM BRT / 03:00-05:00 PM CEST
Please note: This webinar especially addresses the Brazilian pharma industry and will be held mainly in Portuguese.
The introduction of CTD in 2019 in Brazil signified an important shift for Brazilian pharmaceutical entities and a greater shift is expected with the future of eCTD implementation by ANVISA. As the trusted solution provider for more than 35 regulatory authorities worldwide, including the European Medicines Agency (EMA), we know everything about the impact this has on the national regulatory processes.
That is why we are pleased to host this free webinar together with Juliana Rocha (N.G. Reis Consultoria) and Milena Barrozo (Vita Pharma Consulting), our valuable partners in Brazil. Participants will gain a comprehensive understanding of the current status of CTD, the eCTD implementation in Brazil and expected next steps. An overview of CTD and eCTD will be presented, and participants will be empowered with knowledge about EXTEDO’s Regulatory Information Management Platform and tools available to support the future eCTD implementation and digital transformation in Regulatory Affairs. Register now to get ready for this significant transformation of the Brazilian regulatory landscape!
Join Us on Day I to Learn about the Following Topics:
- Current Status of electronic Submissions in Brazil
- Creation of CTD-and eCTD-compliant Documents
- Digital Transformation with the Use of DMS
- Live Demo: Creating a Brazilian CTD in EXTEDO’s submission solution
! Please note that this is only the first part of our joint eCTD experience – to complete your knowledge on eCTD, we strongly recommend to register for the second part as well:
Navigating from CTD to eCTD: A Comprehensive Two-Day Workshop for Brazil, Day II | EXTEDO
Additional Information:
- Not sure you can attend? Register anyway to receive the recording for you to watch.
- The webinar is free of charge and there are no costs applied.
- Every participant will receive a certificate to confirm the attendance.
Speakers:
Milena Barrozo (Vita Pharma Consulting):
Milena Barrozo is a partner at Vita Pharma Consulting, Brazil/Portugal. She is an Industrial Pharmacist graduated by the Federal University of Ceará (UFC), with an MBA in Business Management from Fundação Getúlio Vargas, a postgraduate degree in Regulatory Affairs from ICTQ and a master’s degree in Regulation and Evaluation of Medicines and Health Products from Lisbon University. Milena has 15 years’ experience in the technical (quality assurance and control) and regulatory areas of medicinal products, working mainly on the critical and strategic analysis of technical documentation for product registration, with national and international experience. Milena currently provides consulting services to Brazilian and international companies, and has helped Brazilian companies implement the CTD, from training to converting ANVISA dossiers to the CTD format, as well as drafting a new dossier.
Juliana Rocha (N.G. Reis Consultoria):
Juliana Rocha is a partner at N.G. Reis Consultoria Ltda, São Paulo, Brazil. She is a pharmacist graduated by the University of São Paulo with a master’s degree in Regulatory Affairs and Quality Assurance from Temple University. Juliana has 20 years of regulatory affairs experience with extensive knowledge in global regulatory affairs, having managed preparation of submissions to more than 50 countries, spanning the US, EU, APAC countries and Latin America. Rocha currently provides consulting services to biopharmaceutical companies and Brazilian Pharma Associations where she applies her global experience in evaluating new regulations. Rocha had an important participation in the implementation of CTD in Brazil, providing training to ANVISA as well as major Brazilian Pharmaceutical Industries since 2016.
Nicole Sagner (EXTEDO):
As a Senior Pre-Sales Manager at EXTEDO since 2021, Nicole is responsible for presenting our products and newest features to customers and interested parties, but also gathering requirements to further improve our products and make them fit for future. In addition to her role as Pre-Sales Manager, Nicole brings several other qualifications, including being a Regulatory Affairs Manager, Professional Software Trainer, and Regulatory Consultant. In her past business life, she has been responsible for preparing and executing customer trainings for Regulatory Information Management System, supporting customer implementation projects, regulatory and xEVMPD relevant data administration and xEVMPD data transmissions. Among other, she also engaged in strategic planning and coordination of applications for new marketing authorizations for in-licensed as well as own-developed products, mainly for Europe (national procedures, DCPs, MRPs, RUPs, line extensions).
In addition to her work at EXTEDO, she pursues her passion for Africa and its wildlife as a trained Field Guide & Apprentice Trails Guide in South Africa. Having survived the bush definitely helps surviving the regulatory jungle.
