CDER - Data Submission 101
Mar 27 2013 10:00AM - Mar 27 2013 11:30AM | Online
Overview
This webinar should provide attendees with feedback and assistance to industry concerning the data submissions for regulatory review by the FDA. Discussion will focus on implementation of the Study Data Specifications document and related metadata (eCTD), as well as organization of study data and data-related documents. PDUFA V re-authorization will also be discussed, specifically as it relates to future requirements of study data and data standards.
Who Should Attend
Professionals involved in:
- Regulatory Affairs & Operations
- Regulatory, Medical and Technical Writing
- Data Management
- Document and eRecords Management
- Standards Implementation
Learning Objectives
At the conclusion of this webinar, participants should be able to:
- Discuss how to implement the Study Data Specifications document for regulatory submissions
- Describe the interaction and role of the eCTD with the electronic submission of data
- Identify the future requirements of study data and data standard
Contact Information
Technical Requirements
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Continuing Education
Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102.
As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .2 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded
This program is part of DIA’s Certificate Program and is awarded the following:
• Regulatory Affairs Certificate Program: 1 Elective Units
For more information go to www.diahome.org/certificateprograms
| Name |
Credit Type |
Max Credits |
CEU |
| CDER - Data Submission 101 |
IACET |
1.50 |
0.200 |
Disclosure Policy:
It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.
Statement of Credit:
If you would like to receive a statement of credit, you must participate in the live webinar, and complete the online credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Wednesday, April 10, 2013.
Continuing education credits are available to learners who participate in the live webinar. Continuing education credits are not available for the archived webinar.
To view DIA’s Grievance Policy, please visit the CE page on the DIA website at www.diahome.org/CE
Registration Fees
Other Fees
- Government (Full Time) Individual
- $125.00
- Charitable Nonprofit/Academia Individual
- $175.00
- Group Site
- $799.00
- Group Plus
- $995.00
Member
- Member Individual
- $250.00
Non-Member
- NonMember Individual
- $295.00
Group Discounts
- Group site registration is a license for ONE internet login allowing multiple viewers from one location.
- Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.
CANCELLATIONS
No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.
Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.
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Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.