necessary for the distribution of drugs and devices to improve the care of patients. Gain valuable experience that will allow you to launch a career in Clinical Research or Regulatory Affairs with a company that is dedicated to addressing healthcare needs through breakthrough medical device therapie...
Oxana Iliach, PhDSenior Director, Regulatory Strategy and Policy Oxana has more than 15 years of experience in the healthcare industry including the last 10+ years in regulatory affairs. She specializes in global regulatory strategy and drug development for rare diseases, pediatrics, and biosimilars...
“The Evolving Gene Therapy Regulatory Framework: A Brave New World,” chaired by Snehal Naik, PhD, MA, Associate Director, Global Regulatory Affairs, Scientific Innovation Projects “Real World Data Quality for Regulatory Decision-Making,” presented by Rebecca Lipsitz, PhD, Associate Director, Globa...
TheComplyGuide’s training programs are led by recognized experts and industry veterans with decades of experience in regulatory affairs. Our trainings are available in various formats, such as live webinars, recordings and USBs. View more Meet our Speakers TheComplyGuide’s speakers are chosen ...
Lynn C. Hansen, RAC, is Director of Regulatory Affairs with Pharmatech Associates. Lynn has worked in the development and regulatory management of product programs within the pharmaceutical and bioscience industries for 30 years. Her experience spans the drug development lifecycle from product development...
Bachelor’s degree in a life science required; Master’s degree or PhD preferred 7 years of experience in clinical development, clinical operations, and/or regulatory affairs Related experience working in oncology or immuno-oncology therapeutics ...
Education equivalent to a PhD or MD degree or equivalent in a scientific field, plus at least 2 years’ experience in Regulatory Affairs; or Education equivalent to a MS degree or equivalent in a scientific field, plus at least 4 years’ experience in Regulatory Affairs; or ...
David W. Murray,PhD, is a subject matter expert (SME) of biological medicinal products and regulatory affairs. He is a principal consultant at Parexel International Ireland Ltd., Kilmainham, Dublin, Ireland;david.murray@parexel.com;https://www.parexel.com....
This week, FDA commissioner Scott Gottlieb, MD, announced that the agency’s Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA) are implementing a new agreement to integrate drug review programs with facility evaluations and inspections. ...
Regulatory affairs is another frontier for pharmacists to explore, and pharmacists are just scratching the surface of the opportunities in this area. In this interview with pharmacist Brendan Doran of CTI Clinical Trial & Consulting, he touches on the ma