Programme Structure

PR5302 Drug Development Process

This course studies the drug development process from discovery through FDA marketing approval. It reviews the process of development and the interrelationships linking the various disciplines, introducing students to regulations governing the process, including the interactions with FDA, ICH, and other regulatory agencies.

Module Outline

Biodata of Lecturers

Michael J. McGraw, PharmD, MS, serves as the U.S. lead for regulatory strategy for investigational products for Teva Neuroscience in Philadelphia.  He is experienced in reviewing and preparing regulatory submissions for investigational drugs as well as negotiating with the U.S. Food and Drug Administration for product approvals.  With both regulatory and clinical experience, Dr. McGraw has managed clinical research teams, developed research grants, prepared study documents, submitted documents to IRBs, and created clinical study reports.  Previously he worked for Shire, as a senior associate of regulatory affairs, and at GlaxoSmithKline, as a senior clinical research scientist.  A licensed, registered pharmacist, Dr. McGraw has developed position papers to support new indications for approved drugs and has managed post-approval chemistry, manufacturing and controls changes for various products.  Adept at navigating the complex area of regulatory strategy associated with clinical trials, he also fully understands the developmental life-cycle of a drug product.  He has managed clinical pharmaceutical studies, developed informed consent and case report forms, and managed clinical investigative sites.  Dr. McGraw has taught for the QA/RA and PharmD programs of the Temple University School of Pharmacy, where he received his MS in QA/RA and PharmD degrees.

Module 5302 is one of ten required modules that will lead to a Masters in Pharmaceutical Sciences and Technology, conferred by National University of Singapore. For complete list of modules and entry criteria for Msc (PST) please refer to http://www.pharmacy.nus.edu.sg/prospective/prog_gadmcintro.html