This EU filing and Registration webinar will discuss in brief all the new EU clinical directives, its Impact and how companies can effectively align their filing and registrations processes to effectively implement the requirements of the regulations.

Why Should You Attend:

This course specifically focuses on agencies that control the regulatory process. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in the EU and individual European countries. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations.

The current regulatory climate will be discussed in depth and numerous examples will be provided to illustrate effective filing techniques. Common issues which have caused difficulties for pharmaceutical firms will be discussed. Course content will explain how the EU interacts with national regulatory agencies and how personnel can best address the conflicts that sometimes arise. This course will also be useful for sales or general management personnel who need an overview of the registration process within the EU.