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.
· 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 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.
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.