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.
This two day workshop will provide you with an in-depth review of the content and format requirements of the CTD/eCTD. Hands-on activities will include organizing specific study reports and other documents into the CTD, using tools for the project management of the CTD preparation, and pre-publishing an eCTD.
Who will Benefit:
- Regulatory Affairs
- Quality Assurance
- Project Management
- Regulatory Operations
- Medical and Technical writers
- Professionals preparing IND, DMFs, NDAs and other submissions
- IT Professionals
- Anyone responsible for providing content for the CTD
Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Lecture 1: Overview of the drug development program and source of relevant submission documents
Lecture 2: Discussion of the roles and responsibilities for CTD preparation
Lecture 3: Review of the CTD format requirements
Lecture 4: Discussion on the successful transition from other formats to the CTD
Lecture 5: Placement of content into the CTD format; including less obvious items
Lecture 6: Review of different requirements across regions (US, EU, Canada)
Lecture 7: Implementing tools for the project management of CTD preparation and publishing
Day Two (8:30 AM – 4:30 PM)
Lecture 8: Technical requirements for an eCTD submission
Lecture 9: Document naming requirements
Lecture 10: Building the folder structure
Lecture 11: Internal document requirements for the eCTD
Lecture 12: Performing "pre-publishing" work for each document
Lecture 13: Tools for tracking and managing eCTD content
Lecture 14: Performing quality checks on the eCTD
Lecture 15: Updating content in the CTD and eCTD (amendments, supplements, variations, etc.)
Early bird seats are limited and based on first-come, first-serve.
The registration fee includes: the workshop; all related course materials; morning tea/coffee on both the days, lunch and afternoon tea/coffee on day one.
For discounts on multiple registrations, contact customer care at +1-1-888-771-6965.
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Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.
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Yes, I want to attend "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada: 2-Day In-Person Seminar by Ex-FDA Official"
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Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2479 East Bayshore Road, Suite 200
Palo Alto, CA 94303
Terms & Conditions to register for the Seminar/Conference/Event
Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ firstname.lastname@example.org
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future GRC Seminars event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
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