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10237 WEBINAR: CBER Town Meeting: Hot Topics in eSubmissions
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Title:
WEBINAR: CBER Town Meeting: Hot Topics in eSubmissions
Date(s) And Time(s):
Aug 24 2010 11:00AM - Aug 24 2010 12:30PM
Interest Area(s):
Clinical Research,Regulatory Affairs,Clinical Safety/Pharmacovigilance,Research & Development,Document Management/ eSubmissions,IT/Validation,Medical Writing,Medical Communications,Project Management
Overview:
This interactive webinar is modeled after the popular CBER Town Meeting presented each year at DIA’s Annual Meeting. Participants may submit questions about eSubmissions to senior leadership from the US FDA Center for Biologics Evaluation and Research through an anonymous, computerized Q&A function. Topics discussed during this webinar will depend entirely on the content of your questions.
Submit Your Questions to FDA
Several FDA representatives will be on hand to answer your specific questions and requests for clarifi cation. So that representatives can properly prepare for this questions and answer period, we request that you submit your questions by August 17, 2010 to CBEResubswebinar@diahome.org. You will also have the opportunity to submit your questions during the webinar.
Learning Objectives:
At the conclusion of this webinar, participants should be able to:
• Discuss current eSubmission hot topics at CBER
• Compare/contrast regulatory and industry perspectives on certain biologic development issues
• Discuss recent new guidance’s and other information announced by CBER
Target Audience:
Professionals involved in:
Regulatory affairs Medical writing
Document management Medical communications
Information technology Marketing
Information management Clinical safety/pharmacovigilance
Manufacturing Dictionaries/data standards
Clinical data management eClinical
Quality assurance/quality control Project Management
Event Code:
10237
Contact Information:
For information about this and other upcoming webinars, contact Ben Zaitz at DIA. Tel +1-215-293-5803,
Fax +1-215-442-6199, email benjamin.zaitz@diahome.org
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Webinar
| Charitable Nonprofit/Acad | $175.00 | | Member Standard | $250.00 | | NonMember Standard | $295.00 | | Government (Full Time) | $125.00 | | Group Site | $799.00 | | Group Plus | $995.00 |
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IACET: Drug Information Association has been approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 8405 Greensboro Drive, Suite 800, McLean, VA 22102; (703) 506-3275.
Drug Information Association is authorized by IACET to offer .2 CEUs for this program.
Continuing education credits are available to learners who participate in each session of the live online course. Continuing education credits are not available for the archived sessions of the online course.
| WEBINAR: CBER Town Meeting: Hot Topics in eSubmiss | IACET
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Disclosure Policy:
It is Drug Information Association policy that all faculty participating in continuing education activities must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosures will be included in the course materials.
Statement of Credit:
To request your statement of credit, please go to www.diahome.org. Select “Continuing Education” on the
left menu and select “My Transcript.” You will be prompted for your username and password which will then take you to your transcript. Select the appropriate educational activity from the grid and then choose “Credit Request” in the bottom of the right pane.
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Minimum System Requirements:
Browser
Microsoft® Internet Explorer 5.2 or higher
Netscape® Navigator 7
Computer
166Mhz Pentium-based PC with Microsoft® Windows® 98,
NT, ME, XP or 2000
Sun JVM 1.4* for Microsoft JVM (all versions supported by
Microsoft Windows OS shown above)
Sun SPARCstation with Solaris 8 or 9
Audience: 64 MB RAM
*If you need to install Java Virtual Machine (JVM) on your system, please download it from the Sun Microsystems website.
Internet Connection Speed
56k or faster
Display
800x600 pixel resolution or greater (1024x768 pixels recommended)
Attendees using Macintosh OS
Microsoft IE 5.2
Macintosh OS 10.2X
To test your system compatibility, click on the link below.
https://diahome.webex.com/ec0605l/eventcenter/support/eventManager.do?siteurl=diahome
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Adrienne M Hornatko-Munoz
Consumer Safety Officer
FDA, United States
Amy Malla, MT,PMP
Review Management, Office of the Director, CBER
FDA, United States
Vada A. Perkins, BSN,MSc,RN
Regulatory Program Management Officer, Office of the Director, CBER
FDA, United States
Michael Blanchard Fauntleroy
Program Manager, CBER
FDA, United States
Joseph Montgomery
PDUFA IT Program Director
FDA, United States
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