Understanding Compassionate Use Program Regulations in Latin America (LATAM)
Time: 9:30 am
day: Conference Day Two
Details:
- Examining case studies of successful LATAM compassionate use programs to understand best practices and identify potential challenges
- Highlighting the various access pathways available in LATAM for compassionate use programs, what factors should be considered when choosing a pathway, and who typically leads the decision-making process
- Analyzing LATAM data collection legislations, and which countries do and don’t allow data collection
- Interrogating the regulatory requirements for clinical and commercial supply, import licenses and labeling
