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

Overview:
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 you should 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.

Event link:
https://www.compliance4all.com/webinar/--502959LIVE?channel=theconferencealerts_2020_SEO
Contact Info
Netzealous LLC, DBA -Compliance4all
Email: [email protected]
Phone: +1-800-447-9407
Website: https://www.compliance4all.com/

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