3-Hour Virtual Seminar on FDA's section 804 Drug and 801(d)(1)(B) Biologic Importation Programs

3-Hour Virtual Seminar on FDA's section 804 Drug and 801(d)(1)(B) Biologic Importation Programs: This webinar will give the participants an understanding of the two proposed pathways: Section 804 and Section 801(d)(1)(B), through which the HHS and the FDA will allow the import for certain drugs that are primarily meant for non-US markets

Angela Bazigos
Angela Bazigos
Tuesday, April 21, 2020
10:00 AM PDT | 01:00 PM EDT
3 Hours

More Trainings by this Expert   Product Id : 502959

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This presentation outlines the two proposed pathways through which HHS and FDA will allow for the importation of certain drugs originally intended for non-US markets.

Notably, both pathways rely on parties other than the federal government-such as states, wholesalers, pharmacists, and manufacturers-to demonstrate that eligible drugs can be imported into the US safely and with the required cost savings.

Why should you Attend: Some prescription drug products are priced much higher in the U.S. than abroad, raising questions about the adequacy of competition in U.S. markets for these drugs and whether new policy approaches, such as importation under section 804, might effectively limit prices in those markets and protect consumers from unreasonable price increases.

FDA has determined that a narrow implementation of section 804 through time-limited programs, overseen by states or certain other government entities (with possible co-sponsorship by a wholesaler or pharmacist), could enable importation to occur in a manner consistent with the certification criteria.

This implementation could potentially provide relief to some American consumers from the burden of rising prescription drug prices.

Areas Covered in the Session: Section 804 - Pathway 1

  • Definition of Section 804 Importation Program (SIP)
  • Who would be permitted to sponsor a SIP
  • SIP authorization duration
  • Entities other than a sponsor and co-sponsors (if any) that would be involved in the SIP supply chain
  • Could a SIP Proposal include multiple foreign sellers and importers?
  • Statutory basis for FDA's SIP proposed rule
  • Proposed criteria for a drug to qualify for importation from Canada under a SIP
  • Categories of drugs proposed to be excluded from importation under a SIP
  • SIP sponsors requirements
  • Information required for SIP Proposal
  • Testing requirements for SIP drugs
  • Eligibility criteria for SIP proposal
  • Importation process following FDA approval of SIP proposal
  • Entry submission options
  • Manufacturers:
    • Definition
    • Role in the SIP process
    • Manufacturer requirements
  • Foreign Sellers
    • Definition
    • Role in the SIP process
    • Foreign seller requirements
  • Importers
    • Definition
    • Role in the SIP process
    • Importer requirements
  • Labelling requirements for drugs under SIP program
  • Application of FDA's National Drug Code (NDC)
  • Cost savings for SIP drugs
  • Post importation requirements
  • ederal Health Care coverage and US Drug Price Reporting
  • Supply Chain Security
    • Pre-US supply chain information from manufacturer to importer
    • Supply chain security requirements for foreign sellers
    • Track and trace information from the foreign seller to the importer
    • Purchasing product from a foreign seller if they are not an "authorized trading partner"
    • Information to be confirmed by importer when receiving product from a foreign seller
    • Track and trace information from the foreign seller, as required by the DSCSA
    • SNI portion of the product identifier: can the importer use the same serial number (i.e., the SSI) as the foreign seller
    • Where can importers ship eligible drugs to
    • What other DSCSA obligations would apply to importers
    • Information importer obtains from a manufacturer regarding a product's pre-US supply chain

Section 801(d)(1)(B) - Pathway 2
  • Purpose of Pathway 2
  • Importing drugs under Pathway 2 vs Pathway 1
  • Countries acceptable for Pathway 2
  • Multi-Market Approved (MMA) products
  • Pathway 2 requirements
  • Labelling requirements for MMAs
  • Supplemental approval requirements for MMAs
  • Registration and listing requirements for MMAs
  • NDCs for Pathway 2
  • Supply Chain Security
  • Pricing requirements
  • National Drug Code (NDC) requirements

Who Will Benefit:
  • Regulatory VP
  • Quality VPs
  • IT VPs
  • Regulators
  • Engineering
  • Manufacturing
  • Research
  • Legal
  • Pharmacy
  • Doctors
  • Nurses
  • Hospital administrators
  • Regulatory Affairs professionals: Quality Managers, Quality Engineers
  • Small business Owners, Medical Device Consultants

Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance https://www.google.com/patents/US8266578.

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.

Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences.

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