Piyush Modi
DATE/TIME September 25, 09:00 – 09:30 AM EST TITLE Before FDA Pushback: Using Regulatory Intelligence to De-Risk CMC Submissions SPEAKER Piyush Modi, Director, Regulatory Affairs, Amneal Pharmaceuticals ABSTRACT CMC issues remain one of the most common reasons regulatory submissions run into delays, particularly when gaps emerge around stability, process validation, analytical methods or manufacturing readiness. […]
Ben Locwin
DATE/TIME September 24, 9:20 – 10:00 AM EST TITLE The New Rules of Pharma Outsourcing SPEAKER Ben Locwin, Vice President, Reliant Life Sciences ABSTRACT The sponsor-CDMO relationship is changing as companies face tighter timelines, more complex products, supply chain pressure and rising quality expectations. In this session, healthcare executive Ben Locwin looks at what sponsors […]
