Under what conditions can a pharma company provide financial support for conferences and CME? -
The grants/contributions are separate from other company funds
The company has had no control over the selection of content, faculty, or venue
Not required by ADR reporting: - careful selection of clinical trial participants
Required:
-recognition of events
-safety signals are identified against a background of events
-accurate reporting
Individual board members are known as: - advisors
in vitro diagnostic test - example - microbiology culture
in vitro versus in vivo - in vitro describes something "in glass" such as a test tube or petri dish
in vivo is "within a living organism"
Fundamental requirement for ongoing risk evaluations of REMS: - timely data collection
Best practice and ethical standards for reporting research published in medical journals - ICMJE
,T/F: Elements to Assure Safe Use (ETASU) are required medical interventions taken by HCPs prior to
using the drug. - True
Combination product applicant(s) - The company that holds the application for the combination product
as a whole
T/F: Severe birth defects is not an FDA mandated REMS. - False
Export challenge of a medical device company: - Violation of intellectual property rights
Purposes of IIS - develop and support new indication
enhance pt benefits/health outcomes
improve available product safety and
NOT a purpose = support pt community
Goals of pharmacogenomics - Individualize therapies based on genetic differences
Predict individual responses to a drug to decrease adverse drug reactions
Improve the overall efficacy and safety of drugs
NOT a goal = decrease medication adherence
FDA clearance for medical devices - May be given for devices with substantial equivalence to a known
predicate device
Allows the device to be marketed and sold once a Pre-Market Notification has been submitted
May be issued if the device existed in the market prior to 1976
EBM databases - DynaMed
,Cochrane Library
T/F: Presentation skills are not essential for maintaining a position with MA. - False
What would cause the FDA to require post-marketing studies or clinical trials at the time of approval or
afterwards for a new product? - If the FDA becomes aware of new safety information from SADR
reporting.
When first working on a publication, what should authors do to identify their rights, roles, and
responsibilities? - Document the agreement
The process of internal cooperation, coordination, and common standards across the global
pharmaceutical industry is referred to as: - Harmonization
5-step process to respond to a medical information question - 1) Determine who the audience is
2) Understand what the primary question is
3) Develop an appropriate research strategy
4) Choose the best source
5) Assess the information source and answer the question
T/f: SRDs are prepared only for HCPs in response to questions about product(s). - False
Who is required to submit a periodic safety update report? - Marketing authorization holders (MAHs)
according to the data points outlined in the EURD list.
T/F: Surveys are classified as cross-sectional studies. - True
Medical Device User Fees Amendment of 2012 - Allows the FDA to collect user fees for pre-market
approvals to improve the overall review process
T/F: An abbreviated new drug application (ANDA) is submitted to the FDA for generic drugs. - True
, The risk associated with this type of drug may not be well understood. - New drug substance
Amber is an MSL and receives a question from a physician about a medication indication that is not FDA
approved. Which of the following is true? - This is an unsolicited request.
This information is off-label.
A Pharma company is looking to begin the development of a new drug. Why would the company consult
an advisory board? - To provide their opinion on the research and development of the drug
T/F: Under the second-tier regulations, in 21 CFR Part 56 (Institutional Review Board (IRB)) subpart B,
there needs to be a minimum of 2 members in the IRB. - False
Which are considered key items the FDA will contemplate when deciding on whether REMS is needed? -
Seriousness of the disease
Seriousness of side effects
Benefit of the drug
In research which of the terms below describes a distortion caused by other variables to both exposure
and outcome? - confounding
T/F: Medical writers should avoid addressing the public's questions to prevent the spread of health
misinformation. - False
What are some of the ways that companies can benefit from non-mandated Post-Marketing studies? -
Detect any cost-benefits associated with the drugs
Compare a drug with other currently available medications in the same class
Detect other uses of the drugs
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