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0:00
My name is Professor
Milé Terziovski.
I'm a former engineer with
a multinational organization and
a PhD from the
Melbourne Business
school University of Melbourne.
Our topic was in quality
management and innovation.
For the past seven years,
I have been working at Swinburne
University of Technology
as tenured professor of
entrepreneurship and
innovation where I
held the role as
department chair of
business technology
and entrepreneurship
for six years.
0:32
Today's topic is Topic 7
regulatory considerations.
I'm going to commence with
a quote from Mark Twain,
a well known American writer.
"It ain't what you don't know
that gets you into trouble.
It's what you know for
sure that just ain't so."
Therefore, navigating the
regulatory landscape is
relevant to technology
commercialization and it's very
essential to ensure
compliance and ultimately to
achieve market success in
sectors like biotechnology,
telecommunications and
healthcare in particular.
In this topic I will discuss
the steps required
for compliance,
the role of regulatory agencies
and how to navigate approvals.
I'll also discuss in
a little bit more detail
the regulatory hurdles
faced by Theranos in the
health technology sector.
1:31
Role of regulatory agencies.
Regulatory agencies
play a crucial role
in ensuring the
products are safe,
effective and meet
quality standards.
They provide guidance on
compliance requirements,
review applications and conduct
the inspections of
manufacturing facilities.
They facilitate
communication between
companies and stakeholders
in the approval process.
For example, the food and drug
administration in the USA
oversees the approval of
biologics and
biotechnology products.
In the European Union,
the European Medicines
agency plays a similar role.
For example, biotech
companies must
comply with regulations
regarding clinical trials,
manufacturing practices,
good manufacturing practices
and marketing authorization.
There's also legal and
regulatory requirements.
International IP
protection address
the complexities of
protecting IP in
multiple jurisdictions
discuss international
treaties and agreements
such as the patent
corporation treaty
and the Madrid Protocol
for trademarks.
In terms of compliance
ensures compliance
with relevant IP laws
and regulations.
This includes understanding
the legal requirements for
IP protection in different
countries. Compliant steps.
