s
i
ANANBIOANAL - 2010
Global Harmonization Task
S. B. Puranik
Srinivas College of Pharmacy, Mangalore, India
Pharmaceutical R & D Summit
T
he Global Harmonization Task Force (GHTF) was founded in 1993 by the
governments and industry representatives of Australia, Canada, Japan, the
European Union, and the United States of America to reduce regulatory burdens and
costs for local government and industry. The other emerging issues of international
significance can also be put to the GHTF for a common solution and promotes
technological innovation and facilitates international trade. The GHTF encourages
the technological innovation and facilitates international trade by converging
harmonized guidance documents in standards and regulatory practices related to
the safety, performance and quality of medical devices. The GHTF develops four
different Study Groups, Study Group 1: is charged with comparing operational
medical device regulatory systems around the world. Study Group 2: examines
the requirements for the reporting of adverse events involving medical devices,
post-market surveillance. Study Group 3: is responsible for examining existing
quality system requirements in countries that already have well-developed device
regulatory systems. Study Group 4: is charged with the task of examining quality
system auditing practices. GHTF provides an opportunity for countries to participate
and observe regulatory developments that they could adopt. The current trend
towards a regional harmonization will be useful for countries and also supported by
parallel regional structure.
Biography
Dr. S. B. Puranik has completed his Ph.D in Quality Assurance from RGUHS Ban-
galore. He is the Prof & HOD Quality Assurance of Srinivas College of Pharmacy,
Mangalore, India. He has published more than 25 papers in reputed journals and
serving as a Prof & HOD Quality Assurance Srinivas College of Pharmacy, Manga-
lore, India.
ANALBIOANAL-2010
O
M
I
C
S
P
i
u
h
b
l
n
g
G
r
o
u
p