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Medical Affairs
Medical Affairs
Vision
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“Together we can deliver so much more than medicine in supporting the Individual patient and the Whole community Care Needs.” |
Mission
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“The Medical Affairs is committed to Excellence in services and Wellbeing for the community, and all within the care of our company’s products, by achieving and maintaining the Highest International Standards in Treatment, Education, Research and Community Outreach.” |
Strategic Objectives &
Priorities
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Provide substantial services in 3 areas of Research, Education and Communication aiming to attain organizational commercial effectiveness through cutting-edge scientific updates, premium education & research, judicious outreach to patients, and ethical relationships for a well-built alliance with healthcare community. |
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THE MEDICAL AFFAIRS
DEPARTMENT CONSISTS OF
THE FOLLOWING 6 UNITS:
1. Clinical Research
Unit
This unit administers
and conducts research
studies in adherence to
Good Clinical Practice/ ICH guidelines
and the applicable
regulatory requirements
through its 2 divisions:
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Pre-clinical &
Clinical
Research
Division:
responsible for
outsourcing
bioequivalence,
pharmacokinetic, pharmacodynamic and phase I, II, III studies
and execution of
phase IV post-
marketing studies.
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Global Drug
Safety
Surveillance and
Pharmacovigilance
Division:
responsible for
drug safety
monitoring and reporting as per the competent authorities’
obligation for
pharmacovigilance
of
medicinal products for human use.
2. Medical Information
and Education Unit
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This unit is engaged in
providing updated,
balanced, technical &
scientific information,
medical education about
drugs, diseases &
therapeutic areas and
pharmacoeconomic data
through its 2 divisions:
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Continuous
Education
Division:
responsible to
execute medical
training,
produce
scientific
seminars,
collaborate in arranging and supervising Continuous Medical
Education (CME)
programs to
healthcare
professionals.
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Information
Resourcing
Division:
responsible to
ensure that
internal
colleagues,
healthcare
providers
and authorities are provided with accurate, updated and useful
scientific
information.
Also, to review
and approve the scientific content of post-marketing programs
and materials.
3.
Medical Writing Unit
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This unit is in charge
of developing product
profiles, monographs,
package insert/
patient’s information
leaflet, pharmacology
and toxicology sections
of registration dossiers
with ongoing updates.
Also, it provides
a full range of services
from translation,
substantive editing,
re-structuring and/ or
re-writing of sections,
proofreading and copy
editing including
evaluation of manuscript
for style, grammar,
clarity, and
consistency.
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4. Medical Communication
Unit
This unit offers a
unique scientific
perspective in all new
product pre-launch
activities by:
> Serving in different liaison and communication roles for various
concerned
departments
to ensure sufficient and mutual interaction across them.
> Getting involved in the different phases of product development
as scientific
advisory
and advocacy for product development, life cycle planning,
presentation and
launching.
> Coordinating company's response on external customers’ (i.e.
authorities,
policy maker,
healthcare professionals, patient and principal investigator)
comments or
complaints on
new product.
5. Medical Science
Liaison (MSL) Unit
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MSL unit provides
comprehensive, advanced
and edge-cutting
scientific approach with
Key Opinion Leaders
(KOLs) and healthcare
professionals. The MSL
role is to build and
strengthen relationships
with KOLs via utilizing
the department’s basics
responsibilities in
clinical research,
scholarship, education
via services and
networking to:
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> Increase Julphar awareness among KOLs, improve its credibility
and its image by
focusing on the
long-term relationship and cultivating a high degree of
trust.
> Establish peer-to-peer scientific relationships with thought
leaders and
healthcare
decision makers.
> Enhance Julphar’s competitive intelligence.
> Foster research collaboration between Julphar and KOLs and
champion
research ideas
and
proposals.
6. Patient Affairs Unit
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This unit promotes
Julphar’s image of the
trust and care among
patients, who should
have access to a higher
quality healthcare
including: medicines,
education about their
disease, and information
on the medicines they
take. The Patient
Affairs unit consists of
two divisions:
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Patient
Educational
Advocate
Division:
responsible in
collaborating
with other
concerned
departments or
units to educate
patients on
their disease
state, provide
them with
information
about medication
and advice on
prophylaxis
procedures.
Also, address
questions or
concerns of
patients and
family members
by offering
comprehensive
information via
toll free
number, online
database, as
well as
practical tools,
news, and
articles. In
addition to,
participation in
disease
awareness
campaigns.
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Patient
Assistance
Division:
responsible to
offer a free or
at a low cost
Julphar’s drugs
to patients
experiencing
financial
hardship.
Patients should
provide a proof
of income,
insurance denial
letters, and
prescription or
referral from
doctor.
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