Wayne, PA, April 18, 2007 --(PR.com
)-- CEO & Chairman Jim Walker of Octagon Research Solutions, Inc., a pioneer and leader in the electronic transformation of clinical R&D in the life sciences industry, announced today that Octagon will be hosting an interactive training program on the practicalities and processes of electronic publishing and submission compilation. These training courses will feature Octagon’s Nancy Smerkanich, vice president, Regulatory Affairs as the primary instructor.
This interactive course, eCTD 101: Introduction to the electronic Common Technical Document, is designed to facilitate awareness and understanding of the practical issues and challenges that arise in the implementation of the electronic Common Technical Document (eCTD). Practical examples of lifecycle management and strategies for tracking continuous applications will be discussed. Case studies, meta data gathering activities and exploration of common submission scenarios will reinforce presentation topics in this one-day course.
Learning Objectives for this course are as follows:
· Identify process change and improvement needs in order to proceed towards eCTD
· Recognize and justify document granularity
· Be familiar with the structure of documents in an eNDA and how they map to CTD/eCTD
· Organize metadata and recognize the tagging file utilities
All parties interested in attending the courses may register at Octagon’s training page and by contacting Dan Dehner, Octagon Research Solutions, Ddehner@Octagonresearch.com or 610-535-6500 ext. 5502. If you would like to see the agenda for the training sessions you may find it here.
Dates and Locations for the training are as follows:
· Octagon Headquarters, Wayne, PA - April 18, 2007
· The Hotel @ MIT, Cambridge, MA - May 1, 2007, www.hotelatmit.com
About Octagon’s Nancy Smerkanich:
Nancy Smerkanich, vice president of Regulatory Affairs at Octagon Research Solutions, Inc., is a frequently requested speaker at various industry conferences. Her practical expertise is sought after by large and small pharmaceutical organizations interested in gaining knowledge of the electronic regulatory submission landscape. She has participated in over 100 electronic submissions, has lead multiple tutorials and training programs and continues to provide leadership and actively participate in industry activities such as the Drug Information Association SIACs.
About Octagon Research Solutions, Inc.
Octagon is a pioneer and leading process-centric solutions provider that offers a suite of regulatory, clinical, process, and IT solutions to the life sciences industry. Octagon synchronizes processes and increases automation to reduce island-to-island inefficiencies within the clinical research and development process. They leverage the power of electronic submissions through cross-functional electronic submission expertise, a holistic process approach, deep domain knowledge, and integrated solutions. Octagon is headquartered in Wayne, PA, with European headquarters in Amersham, UK. For more information please visit www.octagonresearch.com.