戻る Agenda
Session 8, Track A: Regulation of Medicinal Products for Rare Diseases in Latin America
Session Chair(s)
Viktoria Magyar, LLM, MSc
Doctoral Student, Department of Regulatory and Quality Sciences
USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
Sonia Viejobueno, LLM
US and Latin America Policy Lead, Global Regulatory Policy and Intelligence
Johnson & Johnson Innovative Medicine, Argentina
This session will discuss the need to adopt regulatory framework, pathways, and tools to allow for timely access to medicinal products for rare diseases. Attention will be drawn to regulatory tools to prioritize or expedite the assessment and registration of treatments benefitting patients with rare diseases in Latin America. A discussion of international best practices and regional trends in the regulation of treatments for rare diseases, and how to bridge regulatory gaps through fostering discussions among regulators and industry representatives, will also be covered.
Learning Objective : - Recognize concepts and international best practices in the regulation of rare diseases
- Identify current regulatory trends in Latin America
- Understand the potential for evolving regulatory frameworks to facilitate greater access to innovative therapies for rare diseases
- Capture the essence of a case study illustrating the use of priority registration pathway in Brazil
Speaker(s)
It is about Time: Opportunities and Best Practices in the Regulation of Medicinal Products for Rare Diseases in Latin America
Representative Invited
Johnson & Johnson Innovative Medicine, Argentina