eCTD Submissions of IND and NDA/BLA to the US FDA

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Category FDA Compliance;

Deadline: May 12, 2016 | Date: May 12, 2016-May 13, 2016

Venue/Country: San Diego, U.S.A

Updated: 2016-04-13 21:05:24 (GMT+9)

Call For Papers - CFP

This 2-day workshop is designed to address all these and provide the attendees with step-by-step instructions in creating and submitting eCTD submissions for IND, NDA, BLA, and ANDA applications without the need for expensive tools or unreasonable efforts. This no-frills workshop aims to train in the minimum skills needed and provide hands-on practical tips to create eCTD submissions. The trainers will use their own case studies of how eCTD submissions were created and successfully submitted to the FDA using indigenous tools and expertise. Also discussed will be logistical issues associated with managing and maintaining eCTD compliance with regards to all regulatory submissions. This workshop will be beneficial to both the novices and experienced in the field.

Who will Benefit:

Regulatory affairs professionals preparing IND, DMFs, NDAs and other submissions

Medical and Technical writers

Project Managers, Directors

Supervisors, and lead workers in Regulatory Affairs

Quality Assurance and Quality Control

IT professionals looking to make eCTD submissions

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/us-fda-ectd-submissions-of-ind-and-nda-bla-seminar-training-80280SEM-prdsm?channel=ourglocal