DIA: Driving Insights to Action
Science:Life Sciences
In 2018, the US FDA approved a record high number–59–of new, novel drugs. “We are at a point now where there is so much innovation in this space and the regulatory aspects are catching up, so we now have three approved gene therapy products in the US and over seven to eight hundred INDs for cell and gene therapy filed with FDA,” explains Dr. Adora Ndu, Executive Director of Global Regulatory Policy, Research & Engagement, BioMarin Pharmaceutical, and Regulatory Science Co-Editor for DIA Global Forum. “With each interaction with each product that’s filed and with each product that’s approved, the regulatory experience is broadened.”
Innovative Partnering Models and Outsourcing Strategies
Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice (GCP)
Trends in Pharmaceutical Quality
Innovative Technology in Clinical Development
Interview with DIA Annual Meeting Co-Chair Dr. Michael Rosenblatt
Innovation in Vaccine Development
Implementing Innovation- Globally Conducive Regulatory Policies
Availability of Medicinal Products: Drug Shortages
Medical Devices and Combination Products
Pharmacovigilance in 2015- Poised for convergence of innovation
Spiros Vamvakas on Early Dialogue with Regulators
Detlef Niese on Translational Medicine
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