|
Octagon's Electronic Submission Practicum
A customizable, mobile training workshop, designed to be delivered within the client environment. The program provides an introduction to the practicalities and processes required for electronic publishing and submission compilation. Presentations will focus on the evolution of eSubs, agency guidance, worldwide implementation status and the fundamentals of creating compliant documents and data. Hands on activities for using and creating checklists for submission deliverables will be incorporated throughout this
one-day course.
Learning Objectives
- Understand how reviewers navigate the electronic submission
- Recognize compliant deliverables for incorporation into electronic submissions
- Implement Practical Planning, recognizing the following -
- Importance of tracking documents across functional areas
- Document mapping across regional submission
For additional details and pricing, please contact Octagon. Fixed price for training plus travel & expenses. [Will vary based on level of customization]
Public Training Course: eCTD 101: Introduction to the Electronic Common Technical Document
This interactive course 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 Study tagging file utilities
to view our training agenda.
Nancy Smerkanich, Vice President, Regulatory Affairs, Octagon Research Solutions, Inc.
Ms. Smerkanich 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.
John Aitken, Managing Director, West Coast Operations,
Octagon Research Solutions, Inc.
John has over 14 years in the pharmaceutical industry, with extensive experience and knowledge in the areas of electronic (eCTD) and paper regulatory submissions in the US and Europe, medical writing, and electronic document management.
Prior to joining Octagon, John was senior director, Regulatory Operations at Elan Pharmaceuticals where he led the migration from paper to eCTD for all US submissions and EU MAAs. In addition, John led the selection and implementation of Elan's electronic document management, publishing and eCTD compilation systems for production of electronic documents and regulatory submissions in the US and Europe.
John also held positions in Medical Writing and Regulatory Operations at
Roche Pharmaceuticals.
Cancellation Policy:
Cancellation must be in writing and received two weeks prior to the course with a $200 administrative charge deducted from the course fee. No refunds will be granted if written cancellation notice is not received two weeks in advance. Registrants are responsible for canceling their own hotel and travel reservations. Registrants who do not cancel properly in advance and who do not attend will be responsible for the full course fee. Octagon reserves the right to alter the date and venue for courses, if necessary. If an event is cancelled, Octagon is not responsible for airfare, hotel or other costs incurred by registrants.
Walk in registrations WILL NOT be accepted. Octagon shall confirm registration in advance and in writing. If you do not receive confirmation within 5 business days of applying, please contact us.
New training dates for 2008 will be coming soon.
Price: $995.00 per attendee
|
