Dr. Moore is currently the Acting Director of CDER's Office of New Drug Quality Assessment (ONDQA) where she is at the forefront of development and implementation of agency QbD initiatives. She is a PhD Chemical Engineer with extensive experience in API process development and manufacturing.
Dr. Moore is currently the Acting Director of CDER's Office of New Drug Quality Assessment (ONDQA) where she is at the forefront of development and implementation of agency QbD initiatives. She is a PhD Chemical Engineer with extensive experience in API process development and manufacturing.
Emer Cooke, European Medicines Agency, United Kingdom
Ms. Cooke holds a MSc in Pharmaceutical Chemistry and an MBA from Trinity College, Dublin. Emer joined EMA as Head of Inspections in Jul. 2002. In Jan. 2009, Emer was appointed first International Liaison Officer for EMA. In Feb. 2012 becomes the Acting Head of Int. and European Cooperation Sector.
Dr. Moheb Nasr joined GSK in September 2011, as Vice President for Global Regulatory Strategy. Prior to joining GSK, Dr. Nasr served as the Director of the Office of New Drug Quality Assessment (ONDQA), CDER, FDA. Dr. Nasr is an elected Fellow of the American Association of Pharmaceutical Scientists
Description
This session will discuss the pathways, similarities, and differences for submitting postapproval changes to an approved Marketing Authorization to the EMA and a supplement to an approved NDA/ANDA to the USA. Speakers from FDA, EMA, and industry will provide a forward-looking view on current challenges of postapproval changes and on potential opportunities for expansion of risk and science based approaches.
Learning Objectives: Identify the different pathways for postapproval changes to FDA and EMA Describe postapproval similarities and differences.