What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries

Event Information
Product Format
Prerecorded Event
60 minutes
Product Description

Review FDA’s Current Policy and Process on Export Certificates


In the US, the Food and Drug Administration (FDA) enforces the applicable federal statute governing FDA-regulated products exported from the United States to foreign countries. Firms in the US exporting FDA-regulated products to foreign countries should submit a certification to the foreign government or their foreign customers. The FDA issues various different kinds of export certificate for FDA-regulated products subject to the federal statute or laws including other statutes that FDA administers.

To be able to export FDA regulated products in the US without delay, whether it is currently marketed in the US or not, firms should understand the documentation requirements including application process to timely obtain certificates issued by the FDA.

In this conference, Dr. Rossano V. Gerald, will guide you through FDA’s current policy and process on export certificates. This conference will provide great opportunities to learn about how to obtain export certificates required for exporting FDA-regulated products from US to foreign countries.

Session Highlights:

  • Laws and Regulations
  • FDA Guidance
  • Definitions
  • FDA Process for Issuing Export Certificates
  • Export and Documentation Requirements
  • Important Information for Exporting FDA Regulated Products: Food, Cosmetics, Animal Drugs, Drugs and Medical Devices
  • Regulatory Requirements Exported from the US
  • Prior Notice Process
  • How to Deal with Refusal to Issue Export Certificates
  • Common Misunderstanding and Key Considerations
  • Enforcement Actions: Case Studies
  • PASS-IT Recommendations: Best Practices

Who Should Attend

  • R&D Scientists, Engineers, Managers, and Directors
  • Regulatory Affairs
  • Quality Professionals
  • Product Development Professionals
  • CROs
  • Consultants
  • Senior Management
  • Contractors and Subcontractors
  • Anyone interested in the subject

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About Our Speaker

Dr. Rossano V. Gerald

Dr. Rossano V. Gerald is an Academic Professor and Founder of RVG International Consulting Firm, LLC. He has over twenty-five years of business experience in, strategic management, marketing analysis, supply chain management; and is a veteran of the United States Army. He has worked with small and medium-sized businesses to help improve their logistic business processes through verification of operational and supply chain programs.  Also, He has developed management...   More Info
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