This course will provide an overview and analysis of the various regulatory activities that take place post-approval: In particular, the current regulatory climate will be discussed in depth and numerous examples will be provided to illustrate effective filing of notification techniques. Common issues which have caused difficulties for pharmaceutical firms will also be discussed. Course content will also discuss the issue of how the EU interacts with national regulatory agencies and how personnel can best address the conflicts that sometimes arise.
The course also covers in depth discussion of international food and drug laws, regulations and guidelines.
This course is intended primarily for students wishing to pursue a career in the pharmaceutical industry, in Regulatory Affairs Departments.