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.
Learning Objectives:This course is designed to provide an overview of the regulatory environment throughout Europe and will provide training in:
- How the EU and individual countries within Europe interact.
- Which registration procedure to use.
- How regulations effect product development strategies.
- Pricing issues Coordinated filing vs. Individual filing.
- Understanding the concerns/issues of European Regulatory Personnel.
- How to negotiate with the regulators.
- Information necessary for effective submissions.
- Strategies for streamlining the registration application process for faster approval.
- The advantages and disadvantages of various registration procedures.
