Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities By compliance2go

14 September 2011, Houston, United States

Introduction

This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Japan, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted