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1st Edition  Conference

Investigational New Drug & Investigational Device Exemptions Applications Preparation and Submission, and Conducting FDA Meetings


"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

Timings

8:30 AM - 4:30 PM (Jun 20) (General)
8:30 AM - 4:30 PM (Jun 21) (General)

Entry Fees

Paid Ticket Starts from 1899 USD View Details

Participants

20
Delegates

5 Exhibitors Estimated Count

Category & Type

Conference
Medical & Pharma
Education & Training

Editions

03-04 Oct 2019 1st Edition


Frequency Bi-annual
Next edition likely in Apr 2020 Interested

Official Links

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ComplianceOnline USA

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User Community [ Users who have shown interest for this Event ]

Sarah

Sarah

Pharmacist at kulkarni law firm

Philadelphia, United States
marta horecha

marta horecha

Doc at Lviv regional Hospital

Lviv, Ukraine
Robert Whit Aker

Robert Whit Aker

Working at Quanticate

Philadelphia, United States
Afrayem botros

Afrayem botros

Pharmacist at MOH

Qena, Egypt
Michael Kuznetsov

Michael Kuznetsov

Medical equipment at Aventic

Orlando, United States

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Visitor Ticket Price

1899 USDAttendee Seminar One Registration
39.953000 -75.165000

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Philadelphia, USA

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