Latin America Regulatory Compliance Forum
Emerging Markets Track
Companies continue to face challenges when conducting clinical trials and registering products globally due to local regulatory requirements and lack of harmonized requirements. Discussion of these topics will help inform industry of potential challenges and will provide opportunities for dialogue and collaboration between industry and regulators to discuss science-based and risk-based approaches to stability.
Take a comprehensive look at the Latin American markets and related regulatory issues:
- Bio-similar regulations update, a harmonization perspective in LA emerging Markets.
- Drug product/ Drug Substance Stability and regulatory compliance update in emerging LA markets
- Manufacturing and dedicated facilities in emerging LA markets
- Investigational Medicinal Products in LA market
At the conclusion of this session, participants will be able to:
- Understand the current regulatory climate in Latin America and common industry issues that have caused difficulties for companies in the region.
- Understand how Latin America Health Authorities utilize ICH standards and what progress has been made in terms of harmonization.