Live Webinar on Understanding the US FDA Drug Review and Approval Process

Wednesday, Jun 15, 2016 at 10:00 AM to 11:00 AM EST

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Wednesday, Jun 15, 2016 at 10:00 AM to 11:00 AM EST

Description :

The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for reviewing and approving both prescription and nonprescription or over-the-counter (OTC) drugs.

To introduce a new drug product into the U.S. market, some firms submit a new drug application (NDA) to the US FDA/CDER.

The firms are responsible for testing a drug and for submitting evidence that the drug is safe and effective.

In 2014 and 2015, the FDA/CDER has approved 41 and 45 novel drugs, respectively.

This webinar is intended to help you better understand FDA’s drug review and approval process. The FDA’s recent approvals of novel drugs will also be discussed.

The speaker will walk you through the regulatory requirements for FDA’s drug review and approvals.

Areas Covered in the Session:

  • Laws.
  • Regulations.
  • FDA Guidances.
  • Definitions.
  • Regulatory Requirements for New Drug Application (NDA) and Biologics License Application (BLA).
  • Drug Development.
  • FDA Drug Review and Approval.
  • Common Mistakes.
  • Critical Considerations.
  • Enforcement Actions.
  • Recent FDA Approvals.
  • PASS-IT Recommendations.

Who will benefit :

  • CEOs.
  • VPs.
  • Compliance Officers.
  • Attorneys.
  • Regulatory Affairs.
  • Clinical Affairs.
  • Quality Assurance.
  • R&D.
  • Consultants.
  • Contractors/Subcontractors.
  • Anyone Interested in the FDA Drug Review and Approval Processes.

For more details :- https://www.grcts.com/GRC-90024

David ben

http://www.grcts.com

GRC Training Solutions is a premier training and solutions company that conducts high impact trainings in Corporate Governance, Regulatory Compliance, Quality Management and Risk Management. GRCs training modules are designed and facilitated by industry experts who possess a strong theoretical and working knowledge of the required regulatory compliance requirements. GRC Training Solutions uses Government and industry best practices and relevant software tools to help companies of all sizes accelerate business performance by helping them understand how to effectively operate within the various guidelines and regulatory frameworks.The training modules are designed for senior and mid level management and executives.

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