VERIFIED ANSWERS 2025(GRADED A+) DETAILED
ANSWERS!!
marketing, management, economics, entrepreneurship, and international business.1.2. Structure of Business ExamsBusiness exams are often a mix of theoretical knowledge and practic
Terms in this set (283) present ideas clearly and concisely. Students must convey complex concepts in a way that demonstrates their understanding of business principles.1.4. Preparing for Business
ExamsPreparing
Most commonly used parallel
study design:
Under what conditions The grants/contributions are separate from other
can a pharma company company funds
provide financial support
for conferences and The company has had no control over the selection
CME? of content, faculty, or venue
, careful selection of clinical trial participants
Required:
Not required by ADR
-recognition of events
reporting:
-safety signals are identified against a background
of events
-accurate reporting
Individual board advisors
members are known as:
in vitro diagnostic test - microbiology culture
example
in vitro describes something "in glass" such as a test
tube or petri dish
in vitro versus in vivo
in vivo is "within a living organism"
Fundamental timely data collection
requirement for ongoing
risk evaluations of REMS:
Best practice and ethical ICMJE
standards for reporting
research published in
medical journals
marketing, management, econ present ideas clearly and concisely. Students must convey complex concepts in a way that demonstrates their understanding of business principles.1.4. Preparing for Business ExamsPreparing omics, entrepreneurship, and
international business.1.2. Structure of Business ExamsBusiness exams are often a mix of theoretical knowledge and practic
, T/F: Elements to Assure True
Safe Use (ETASU) are
required medical
interventions taken by
HCPs prior to using the
drug.
Combination product The company that holds the application for the
applicant(s) combination product as a whole
T/F: Severe birth defects False
is not an FDA mandated
REMS.
Export challenge of a Violation of intellectual property rights
medical device
company:
present ideas clearly and concisely. Students must convey complex concepts in a way that demonstrates their understanding of business principles.1.4. Preparing for Business ExamsPreparing
marketing, management, economics, entrepreneurship, and international business.1.2. Structure of Business ExamsBusiness exams are often a mix of theoretical knowledge and practic
develop and support new indication
enhance pt benefits/health outcomes
Purposes of IIS improve available product safety and
NOT a purpose = support pt community
, present ideas clearly and concisely. Students must convey complex concepts in a way that demonstrates their understanding of business principles.1.4. Preparing for Business ExamsPreparing
marketing, management, economics, entrepreneurship, and international business.1.2. Structure of Business ExamsBusiness exams are often a mix of theoretical knowledge and practic
Individualize therapies based on genetic
differences
Predict individual responses to a drug to decrease
Goals of
adverse drug reactions
pharmacogenomics
Improve the overall efficacy and safety of drugs
NOT a goal = decrease medication adherence
May be given for devices with substantial
equivalence to a known predicate device
FDA clearance for Allows the device to be marketed and sold once a
medical devices Pre-Market Notification has been submitted
May be issued if the device existed in the market
prior to 1976
DynaMed
EBM databases
Cochrane Library
T/F: Presentation skills False
are not essential for
maintaining a position
with MA.