Preparing Compliant eCTD Submissions 2017

2017

Rockville, MD, United States

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Preparing Compliant eCTD Submissions 2017 is a Workshop dedicated to

Acronyms and words surrounding eCTD and electronic submissions
Best practices with software used to generate electronic submission content
A plan for transitioning your company into submitting in the eCTD format
Technical requirements of the content of an eCTD submission
EU submissions and procedures and how eCTD is different in the US and Europe
ECTDs to minimize the chance of Refusal to Review and Refuse to File (RTF) actions by FDA

Who should Attend

Entry to mid-level regulatory professionals working in the biologics, drugs or combination products fields:

Regulatory operations
Medical writers
IT staff
Submissions publishing

Past Events

Preparing Compliant eCTD Submissions 2017 - 2017, Rockville, Maryland, United States (24775)

Preparing Compliant eCTD Submissions 2016 - 13-14 Apr 2016, US Pharmacopeial Convention Rockville, Maryland, United States (24776)

Preparing Compliant eCTD Submissions 2015 - 15-16 Apr 2015, RAPS Training Center, Rockville, Maryland, United States (43889)

Preparing Compliant eCTD Submissions 2026

Important

Please, check "Preparing Compliant eCTD Submissions" official website for possible changes, before making any traveling arrangements

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