3/5/2014 11:50:06 AM
With constantly evolving FDA regulations, it is becoming difficult for pharmaceutic
companies to create and maintain
content to effectively
managing submissions and changes, the labeling process is becoming more complex
with so many companies beginning to market their products
ompanies are finding it increasingly important to document core
eir company core data sheets to direct local affiliate labeling more
Senior Director, Labeling Strategy at
speaker at th
Pharma Labeling Compliance Conference
expertise working with global affiliates and core data sheet management in an exclusive
one interview with marcus evans.
The responses below strictly reflect the views
nd beliefs of
and not necessarily those of
What was the main factor that sparked your interest in participating in
Pharma Labeling Compliance Conference?
My colleague partici
pated in the
Pharma Labeling Compliance Conference
thought it provided a great opportunity to interact with colleagues from other
companies and exchange best practices across all
issues that we
deal with on daily basis.
xcited to see topics on this year’s conference that are
very relevant to my every day work
Working with global affiliates is a major priority of this year’s
delegation. What critical information must be included in core da
ta sheets to facilitate
an efficient working relationship with affiliates?
important to consider
core information need
to be included in every local
country label from the core data sheet
versus those that
up to the local affiliates to
decide based on their local regulations. It
also very important that a level of priority is
given to each update from the core data sheet, so the global affiliates know the priority
for updating their local labels
a major safety informatio
n update should
get a priority level that affiliates recognize for filling in their local countries.
What processes have you put in place to assist global affiliates with
implementing core data into their labels
At GlaxoSmithKline, we
many processes in place to help global affiliates with
implementing core data information in their local labels. We
have a very
of dispatching core data sheet updates to all LOCs
. There is also a
outlines the level
of importance of each update and the timeframe
requirement by each LOC to
file in their local countries.
Not all updates to the core data
sheet require the same
marcus evans: What are some of the key challenges you’ve faced when integrating
bal regulations into core data sheets? How have you overcome these challenges?
We try to avoid using specific local regulations in the core data sheet as much as
something that is only to satisfy one region, then we make
to require that as
core information, so not all other countries need to implement. For
put any pregnancy category in the core data sheet as that is only for
use in the U
marcus evans: Is there a particular approach you’ve found to be
most effective in the
development and management of core data sheets? Please explain.
Yes, we have found
important for the teams to understand
developing and updating
sheet. We also try to develop our core data
t in parallel to the major local labels such
US PIs and SmPCs, so the teams can
understand and distinguish between what is our company position and what may need
to be adjusted based on local regulatory requirements.
Roya Behbahani will be covering the
“Developing a Core Data Sheet that will
the Creation of Local Labels,” at the
20, 2014 in Boston, MA.
For more information
please contact Robin Yegelwel, Marketing & PR Coordinator, at
3000 ext. 6483 or
Roya Behbahani, PharmD
a Behbahani received her PharmD
from the Philadelphia College of Pharmacy and
Science. After receiving her degree, Roya completed a fellowship in Pharmacokinetics
and received her
MBA from Regis University in Denver, Colo.
Roya has been with Glaxo
SmithKline for the past 18 years and
has held several positions
within the medical information department and labeling groups. Prior to her position at
GlaxoSmithKline, Roya worked as a C
linical Pharmacist at Cooper Hospital in Camden,
New Jersey and an Adjunct Professor at Philadelphia College of Pharmacy and Science.
About marcus evans
marcus evans conferences annually produce over 2,000 high quality events designed to
provide key str
ategic business information, best practice and networking opportunities
for senior industry decision
makers. Our global reach is utilized to attract over 30,000 speakers annually; ensuring niche focused subject matter presented directly by
d a diversity of information to assist our clients in adopting best practice
in all business disciplines.
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