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ABOUT THIS WORKSHOP
Companies developing drugs that have not been previously approved for
the proposed clinical indication, dosing regimen or patient population
must submit an Investigational New Drug (IND) application to the FDA
prior to initiating research on human subjects. In recent years, the
FDA has developed fast-track programs to help accelerate this process
for drugs addressing serious or life-threatening conditions and/or
unmet clinical needs. Navigating the options for innovative ideas and
cost-effective clinical strategies requires scientific and regulatory
expertise, as well as input from the FDA itself.
Join this workshop to learn how to:
*
Develop a strategy for acquiring information required for submission
including pre-clinical safety for testing in human subjects, quality
information, clinical information, CMC data, general investigative
plan for clinical studies over the upcoming year, the Investigator’s
Brochure and other information
*
Create flexible submission materials to meet regional requirements
*
Determine if your product qualifies for Fast Track or other special
designations for the IND submission process
CAN'T ATTEND IN PERSON? JOIN US IN OUR VIRTUAL CLASSROOM. To join
this workshop virtually via Webex, select the "Virtual classroom"
ticket type at checkout - access instructions will be included in your
email receipt.
ABOUT THE INSTRUCTOR
Richard Johnson, Ph.D., of BioPhia Consulting, is a protein biochemist
with extensive experience in biologics and medical device development.
He has lead teams in the development of anti-inflammatory biologics
(both protein and nucleic acid based) and is a complement biochemistry
expert with extensive experience in hemocompatibility applications
(from novel coating technologies to regulatory testing requirements
(ISO10993 Part 4)). He is proficient in protein isolation,
characterization, modification, and structure-function analysis,
including ligand-receptor interactions, forced degradation studies and
immunogenicitym as well as cell isolation, cell culture and analysis,
including flow cytometry, working with WBC subsets and CD34+ human
stem cells. Prior to BioPhia, Richard headed research/development
departments at Baxter and started a biotech company based on
complement-inhibiting peptides. He is currently and Adjunct Professor
at Rosalind Franklin University.
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16/11/2018 Last update