Speakers

John Derstine is a Senior Director in Generic Regulatory Affairs at Teva Pharmaceuticals and leads a global team responsible for pre- and post-approval activities for a portfolio of sterile and non-sterile products. In his current role, he provides regulatory guidance, strategic decision-making and supports various initiatives intended to ensure that quality submissions are submitted to the Food and Drug Administration (FDA). He is actively involved with various aspects of generic drug development, as well as submission, which has resulted in the FDA approval of various applications over the years. John joined Teva in January 1999 and has held various positions with increasing responsibilities in both Quality Control and Regulatory Affairs. He has over 20 years of regulatory experience.