- email:registration@pti-europe.co.uk
- phone:+44 (0) 20 7017 7481
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Building the eCTD
16 - 17 May 2013
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INTERACTIVE LEARNING TOOLS
...including case studies, group discussions, and scenariosTRACK
...and manage multiple agency submissionsPRACTICAL INSIGHTS
...into how the Regulators review eSubmissionsPLAN, ORGANISE & SUBMIT
...successful and compliant eCTDs
Building the eCTD
Course Objectives
Filing new submissions is a time consuming, laborious task for both industry and Regulators alike. The sheer size of each submission leads to costly time delays at every stage of the process. Using the eCTD has been proven to speed your data through the approval process, saving you valuable resources and time.
Global regulatory agencies are committed to implemeting the eCTD as standard. Are you? Attend this practical 2-day course and ensure your applications are in the correct electronic format and style from the onset.
What Will You Learn?
Performance & Knowledge Objectives of this Course
- Establish more efficient processes to build, publish and deliver your regulatory submissions
- Meet the challenges of adopting the eCTD on a global scale
- Clarify regulatory requirements and improve your agency communications
- Track and manage multiple agency submissions with effective life cycle management
- Identify the latest challenges presented by the new eCTD validation criteria
Who Should Attend?
Regulatory Affairs and Operations
- Dossier Management
- Document Management
- Data Management
- Compliance
- Electronic Publishing/ Submissions
- Global Project Management
- IT/IS
- EDMS
Dates and Venues
16 May 2013 - 17 May 2013
Radisson Blu Edwardian Grafton
Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals