OCTAGON RESEARCH SOLUTIONS INC., TO OFFER TRAINING IN SIX CITIES ENTITILED eCTD 101
Wayne, Pa. - April 25, 2006 - CEO & Chairman Jim Walker of Octagon Research Solutions, a pioneer and leader in the electronic transformation of clinical R&D in the life sciences industry, announced today that Octagon will begin an interactive training program in six cities throughout the United Sates and Canada, 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:
- 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
“I am proud to be announcing the availability our suite of comprehensive training offerings focused on evolving electronic submission requirements,” stated Mr. Walker, “We are leveraging our industry experts, such as Ms. Smerkanich, who have extensive practical knowledge of the benefits and challenges of electronic submissions. We have developed these programs simply to promote both knowledge and a better understanding of the regulatory submission landscape.”
Dates and Locations for the training are as follows:
Wayne, Pennsylvania- May 12- Octagon’s Corporate Headquarters
Chicago, Illinois- July 19, Embassy Suites- Lakefront
San Francisco, California- August 16, Embassy Suites, Bay
Boston, Mass.- September 13, Hotel at MIT
Toronto, Ontario, CAN- October 4, Sutton Place Hotel
Tampa, Florida- November 8, Embassy Suites, Tampa
All parties interested in attending the courses may register at http://www.octagonresearch.com/OctagonTraining.html and by contacting Dan Dehner, Octagon Research Solutions, Ddehner@Octagonresearch.com or 610-535-6500 ext. 5502.
About Octagon’s Nancy Smerkanich:
Nancy Smerkanich, Vice President of Regulatory Affairs at Octagon Research Solutions, 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.
Octagon was also included on Entrepreneur magazine’s “2003 Hot 100 list,” Deloitte & Touche’s “2003 Fast 50 Rising Stars” list, Deloitte & Touche’s “2004 Fast 500” and “2004 Fast 50” lists, and Inc. magazine’s “2005 INC. 500” list recognizing it as one of the fastest-growing, privately held companies in the United States.
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. We leverage the power of electronic submissions through cross-functional eSub expertise, a holistic process approach, deep domain knowledge and integrated solutions. Octagon is headquartered in Wayne, PA, with offices in Boston, MA, Costa Mesa, CA, and European headquarters in Amersham, UK. For more information please visit www.octagonresearch.com.
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