This Regulatory compliance training is designed to provide an overview of the regulatory environment throughout Europe and will explain how the EU interacts with national regulatory agencies.
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.
Areas Covered
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.
Instructor
For the past 9 years, Robert J. Russell has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance.
RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.