FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs 2019

23 May 2019
Webinar

FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs 2019 is being held on 23 May 2019.

FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs 2019 is a webinar that covers topics such as:

  • Definitions
  • Applicable Statute(s) and Regulations
  • Categories Approvable under 505(b)2
  • Common Misconception
  • 505(b)2 Applications: Contents
  • 505(b)2 Requirements
  • Drug Examples Approved under 505(b)2
  • CMC Requirements under 505(b)2
  • Important Considerations
  • Injectable Biologics Approved under 505(b)2
  • PASS-IT Recommendations: Best Practices

FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs 2019 is intended for:

  • VPs
  • CEOs
  • Attorneys
  • Compliance Officers
  • Clinical Affairs
  • Regulatory Affairs
  • R&D
  • Quality Assurance
  • Contractors/Subcontractors
  • Consultants
  • Anyone Interested in the FDA Drug Review and Approval Processes
220 US Dollar
No exhibition
Rentalcars Savings

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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