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Filing Regulatory Submissions with FDA Using new Module 1 Specifications

May 24, 2016 @ 10:00 - 11:00 UTC+0

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** IMPORTANT NOTICE **

This live webinar event, upon documented attendance, can grant you 1 Credit towards your RAPS RAC recertification.


Webinar Topic:

Filing Regulatory Submissions with FDA Using new Module 1 Specifications

Webinar Date/Time:

Tuesday, May 24, 2016 at

10:00 am edt (NYC, USA)

3:00 pm bst (London, UK)

4:00 pm cest (Paris, FR)

Webinar Host:

ted hanebach

Ted Hanebach

Director of Regulatory Operations at Mapi Group

Webinar Description:

As of June 15, 2015, the FDA is accepting submissions using the new Module 1 specifications (v.2.3). Although the previous version of Module 1 (v.1.3) is still acceptable to the Agency, filing submissions in the new format may be highly beneficial for the sponsor and regulators.

This Webinar will discuss the benefits of using the new specifications, as well as, provide a summary of potential challenges sponsors may encounter during preparation, filing, and management of regulatory submissions.

Register to attend this event:

http://webinars.mapigroup.com/filing-regulatory-submissions

Details

Date:
May 24, 2016
Time:
10:00 - 11:00
Event Category:
Event Tags:
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