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.



View Course Agenda

Past Participant's Comments:

"Excellent training.  Excellent Instructor.  Best training I have ever taken.”
Janessa R., Compliance Specialist – Regulatory, Pfizer

“Very informative!  The Course Director is well-versed in his area of expertise and no questions are left unanswered.”
Victoria, Associate Director, Wyeth

“The course was outlined in a very easy-to-follow manner.  The instructor was very approachable and extremely knowledgeable.  He went out of his way to answer all questions."
Lars S., Technical Manager, Schering-Plough

“The training was excellent.  I would highly recommend this seminar to my colleagues..”
Nylia R., QA Training Consultant, Eli Lilly

“Instructor articulated subject matter extremely well, tailored the course to the participants, was available to continue discussion during breaks and outside course hours.”
Michael D., Director of Execution Strategy and Management, Schering-Plough

“The Course Director was very knowledgeable in the subject matter and expressed this in a clear and concise way with real examples.  I would say it is the best training I have taken on European Filing and Registration.  The best tools he gave us during training was the schematic on how the EC, EMA, CA’s, CHMP…interact with one another.  He clarified a lot of questions I had on the process.”
Delia D., Regulatory Conformance Team Leader, GlaxoSmithKline

“The training was very suitable for the intended purpose.  All the these discussed in the training will be very useful for my work activities as a Regulatory Conformance Analyst.  The material provided was so clear.  In general, the training was well performed…great speaker!”
Yesenia G., Regulatory Conformist Analyst, GlaxoSmithKline

“I found the course to be very informative.  The course content appeals to persons of all experience levels.  The Course Director was very knowledgeable and was able to share real-world examples with the class.  I think this course would benefit anyone in the Quality and Regulatory areas.”
Keri R., Senior Quality Engineer, Abbott Laboratories

“Excellent Course Director.  Clear in his explanations, knowledgeable.  Topics covered provide an in-depth explanation of the process.”
Lisandra B., Sr. Regulatory Affairs Representative, Eli Lilly

“Excellent introductory course for people/professionals new to the regulatory field.”
Ada N., Regulatory Manager, Pfizer

“It was fantastic!  Now I have a better idea on how to work with the European community and how to file/register new products and changes within the OUS materials.”
Yvette A., Sr. Regulatory Affairs Representative, Eli Lilly

“Great class, the instructor managed to reply information in an enthenisiatic manner.  Highly recommend to fellow industry personnel.”
Calandra , B., CQA Manager, Cephalon