Marketing Authorisation in Latin America - Focused insights on regulatory strategies in Brazil,
Mexico, Peru, Colombia, Chile and Argentina

- LATAM pharmaceutical landscape: market potential, harmonisation trends and regional dossier formats - National procedures and updates - Dossier requirements for NCEs, generics and orphan drugs - Lifecycle management: variations, renewals, labelling and inspection readiness - Fast-track initiatives, digitalisation, reliance models and mutual recognition - Case-based learning: practical exercises, country-specific challenges and cross-country strategyAn 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.LernzieleWhat 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 regions 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 will 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.ZielgruppenThis online seminar is designed for professionals working in Regulatory Affairs and related departments who are involved in marketing authorisation and product maintenance for Latin American markets.- The seminar will focus on human medicinal products (chemicals and biologics; herbals will not be addressed).- Basic understanding in regulatory affairs is required.