Who Should Attend
This course will be of benefit to regulatory personnel whose responsibilities require knowledge of the EU and European country regulatory environment. Administrative staff responsible for ensuring compliance with regulatory filings will also find this training highly relevant. Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit.
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
Course Description
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.