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eCTD Submissions 2018 - Common Technical Document Guidelines

eCTD Submissions

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Who should attend?

Regulatory Affairs Quality Assurance Pharmacovigilance Project Management Regulatory Operations Anyone responsible for providing content for the CTD


Overview: The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. Beginning in May 2017, the eCTD will be required in the US for all marketing applications.Why should you attend:This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.Areas Covered in the Session:• Overview of the drug development program and source of relevant submission documents• Discussion of the roles and responsibilities for CTD preparation• Review of the CTD format requirements• Discussion on the successful transition from other formats to the CTD• Implementing tools for the project management of CTD preparation and publishing• Technical requirements for an eCTD submission• Document naming requirements• Building the folder structure• Performing "pre-publishing" work for each document• Tools for tracking and managing eCTD content• Performing quality checks on the eCTD• Updating content in the CTD and eCTD (amendments, supplements, variations, etc.)Who will benefit:• Regulatory Affairs• Quality Assurance• Pharmacovigilance• Project Management• Regulatory Operations• Anyone responsible for providing content for the CTDLocation: Baltimore, MD Date: April 5th & 6th, 2018 and Time: 9:00 AM to 6:00 PMVenue: WILL BE ANNOUNCED SOON Baltimore, MDPrice:Register now and save $200. (Early Bird)Price: $1,295.00 (Seminar Fee for One Delegate)Until February 28, Early Bird Price: $1,295.00 From March 01 to April 02, Regular Price: $1,495.00Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminarAt this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry. As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants. For More Information- Contact us today!NetZealous LLC DBA Toll free: +1-800-447-9407Phone: +1-510-584-9661 Website: http://www.globalcompliancepanel.comRegistration Link - us on LinkedIn: us our Facebook page: us on Twitter:


Price: $1,295.00 (Seminar Fee for One Delegate) Until February 28, Early Bird Price: $1,295.00 From March 01 to April 02, Regular Price: $1,495.00 Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*


John Robinson

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