Come join us to connect with others from your local regulatory community and hear an interactive presentation on health needs from a global perspective. This session is brought to you by the RAPS Indiana Chapter and is intended to promote engagement between government, industry and academia. A light meal will be provided. RAC holders may claim two RAC recertification credits.
Over the past two decades, the global pharmaceutical development model has evolved to aggressively address drug development for many of the neglected tropical diseases, tuberculosis, malaria, and several other diseases of poverty. Global initiatives have brought together stakeholders that have energized drug discovery efforts. While much of these initiatives are focused on accelerating drug discovery and clinical trials, there is limited focus on aspects of drug development and regulatory science, which continue to be a challenge for the developing world.
Many of these regions face challenges in the regulatory arena from lack of expertise, lack of resources, as well as absence of a harmonized and coordinated drug approval process. In addition, you will also learn about another area of growing concern regarding the detection and prevention of counterfeit drugs from circulating in these markets.
At the conclusion of this program, you will have a better understanding of:
- Key challenges, implemented solutions, and future opportunities for drug product development from a global health perspective, with focus on CMC challenges
- Considerations for patient centric product development when addressing global health issues
- Regulatory barriers that impact drug product registration in resource constrained environments
- Experiences from the Purdue BIRS program