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"Guidance documents for drug and device submissions"
Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. Through formal lectures, case studies, and hands-on exercises, new and experienced regulatory professionals will learn how to interpret regulations and guidance documents to produce submissions that comply with the requirements and are clear to the reviewers.
Highlights
- Contents of IND and IDE,Submissions to IND or IDE to the FDA,Amendments to IND and IDE applications
- Regulatory requirements for IND and IDE application process,Establishing communications with FDA
- Type of FDA meetings,Create checklists that encompass timelines and sections needed from contributor
- Identify the required regulations and guidance documents for drug and device submissions
- Formulate a working knowledge of regulatory submissions, publishing and style guides, FDA meetings
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Timings8:30 AM - 4:30 PM (Jun 20) (General)
8:30 AM - 4:30 PM (Jun 21) (General)
| Entry FeesPaid Ticket Starts from 1899 USD View Details |
Estimated Turnout20 Delegates 5 Exhibitors | Event TypeConference |
EditionsOct 2019 1st EditionFrequency Bi-annual | Official LinksWebsiteContacts Report Error Claim this event |
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39.953000-75.165000 Venue Map & DirectionsVenue to be announced Philadelphia, USA | |
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Visitor Ticket Price
| 1899 USD | AttendeeSeminar One Registration |
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Add Your Review EditionOct 2019
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Speakers
Speaker
Peggy J. Berry
MBA, RAC,President & CEOVisitor Ticket Price
| 1899 USD | AttendeeSeminar One Registration |
39.953000-75.165000
Venue Map & Directions
Venue to be announced
Philadelphia, USA
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