Export of FDA Regulated Products from US to Other countries: Export Certificates and Other Documents

Duration: 60 Minutes
FDA issues about 7 different kinds of export certificates for products intended to be exported from the US to other countries. These certificates are needed for the importing country; without such certificates these products will not be allowed entry into the importing country. Many companies export not only products marketed in the US but also products that may not be legally marketed in the US but are allowed in other countries.
Export Compliance Certification
Instructor: Mukesh Kumar
Product ID: 500832

For exporters of drugs, biologics, medical devices, diagnostics, food, and all other kinds of products or components it is important to have an understanding of the documentation requirements, application process, expectations of the FDA, and the importing country to avoid delays due to custom clearance. Before FDA can issue an export certificate to a company, it requires detailed compliance documents and other paperwork from the applicant. Incomplete and inaccurate documents are the most common reasons for delays and denials of export certificates.

This webinar will provide practical instructions on the process of getting export certificates from FDA including description of key terms, concepts, and common issues that exporters of FDA-regulated products are likely to encounter.

Why Should you Attend:
This webinar is intended for exporters of FDA regulated products or those that sell regulated products to the U.S. exporters and wish to have a better understanding of how FDA regulated products are exported from the U.S. Attendees will be introduced to the types of export certificates, conditions under which FDA issues or denies export certificates, legal requirements, fees, and regulatory requirements for export of FDA-regulated products from the US. Attending this training will help you to better manage your export compliance activities and help support your logistics supply chain.

Objectives of the Presentation:
This online training session aims at covering areas such as:
  • FDA export certificate issuance process
  • US Customs export documentation requirements
  • FDA export product codes
  • Regulatory requirements for exported products
  • Prior Notice process
  • Role of US agent for exports
  • Dealing with refusal to issue export certificates
Who can Benefit:
  • Exporters of FDA regulated products to other countries
  • Foreign exporters and importers of FDA regulated products (companies which buy regulated products for non-U.S. sales)
  • Compliance Officers
  • Logistics/Supply Chain Managers and Analysts
  • Trade Regulatory/Legislative Affairs Professionals
  • Sales/Marketing Personnel
  • International Business Operations
  • Customs or Trade Compliance Personnel or Officers
  • Export or Global Trade Directors or Managers
  • Export Supervisors
  • Customs Brokers
  • Companies interested in exporting US products to other countries for sales and reprocessing

This webinar is a part of "Import Export Regulations" Webinar Series. Click here to know more.


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Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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