Ms.
Trudie Seeger, Ph.D., is the Global
Head of Regulatory Affairs and
Quality Assurance (QA) for Veeda
Oncology and is responsible for
overseeing all regulatory aspects of
Veeda Oncology studies as well as
ensuring quality, both within the
company and in the conduct of the
clinical trials.
With more than 25 years of
diversified drug development and
management experience, Ms. Seeger
has an expansive career portfolio
focusing on all Regulatory and QA
aspects of Phase I-IV
investigational studies of both drug
and devices, with a focus on
oncology products. She managed the
development of two ethical products
from conception to market for a
major pharmaceutical company as well
as directed regulatory strategy of
an innovative biotechnology product
to marketing authorization in the
US, Europe and Asia. She is
intimately familiar with ICH, GCP,
QSR and GMP regulations as they
relate to manufacturing, design,
execution, conduct, and reporting of
studies in the US and
internationally. She is able to
develop all forms of clinical and
regulatory documents related to
product development and marketing
approval including INDs, IDEs,
510(k)s, PMAs, PDPs, NDAs and BLAs.
Ms. Seeger worked for 18 years in
the pharmaceutical and biotech
industry of which 14 years were in
clinical research including
positions as Clinical Research
Associate, Project Manager, Director
and Vice President. More recently,
Ms. Seeger has utilized her QA and
Regulatory experience and expertise
in the field of Oncology to provide
services to pharmaceutical,
biologics, and the device industry.
Ms. Seeger received her BA in
Biology from D’Youville College, MS
in Natural Science and her Ph.D. in
Experimental Pathology from State
University of New York at Buffalo.
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