13 June 2012

US FDA Scheduled the meeting: Update to Electronic Common Technical Document Module 1

The US Food and Drug Administration (FDA) has announced meeting to update and discuss the new version of the eCTD Module 1 document. The purpose of this meeting is to provide clarification and answer questions from industry and software vendors regarding the changes being made to the module 1 by FDA.

Date and Time of meeting: 18th September 2012 (Tuesday) from 8 a.m. to 11:30 a.m.

Location:                     FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31                                                    Conference Center, Great Room 1503, Silver Spring, MD, 20993.

Registration Limit:      only 350.

Registration Process:   Need to send registration information including name, title, firm name,                                           address, telephone, and fax number to Julie Quinonez.

Contact Information:  Julie Quinonez,
                                    Center for Drug Evaluation and Research, Food and Drug
                                    Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 1135,
                                    Silver Spring, MD, 20993,
                                    301-796-0282, FAX: 301-796-9876,
                                    email: Julie.Quinonez@fda.hhs.gov

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