European Filing and Registration Procedures
Thursday, October 13, 2016 from 10:00 AM to 11:30 AM (PDT)
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 in the Webinar:
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.
Who Will Benefit:
• 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.
Robert J. Russell, For the past 9 years, Bob 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.
Note: Use coupon code NB5SQH8N and get 10% off on registration.
When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.