Justina is a pharmacist and attorney, and a commissioned officer in the U.S Public Health Service. She is currently the Associate Director for International Programs, CDER/USFDA One of her primary responsibilities is coordination of CDER’s efforts related to the ICH.
Biologist with 17 years of experience in the pharmaceutical industry and CROs. Strong expertise in managing multi-national clinical trials under operational and regulatory aspects. Hands-on experience with clinical trial applications and coordination for multi-national clinical trials.
Frank Hubbard, Astrazeneca Pharmaceuticals LP, United States
Description
This session will explore global medical writers' proven strategies for authoring regulatory submission documents for clinical trial and marketing applications with overlapping content being submitted virtually simultaneously to different regional authorities.
Learning Objectives: Identify medical writers' proven strategies for authoring regulatory submission documents for clinical trials Discuss the marketing applications with overlapping content being submitted virtually simultaneously to different regional authorities.