Module 2
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Ohio State University *
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Course
7770
Subject
Medicine
Date
Dec 6, 2023
Type
docx
Pages
2
Uploaded by dankescone
Three regulatory competencies and associated activities required in medicines development are
regulations, quality and strategy. Regulations require the ability to apply and interpret different
guidelines for agencies relevant to medicines, including the knowledge to identify medicine
designs and change those designs to meet national and international approval. This regulatory
competency also requires the ability to plan and coordinate the approval of market submissions,
including clinical trials, when applicable. It must also be in compliance with the FDA in regards
to its market applications and regulatory requirements. This includes issuing recalls when
necessary and providing corrective action. Within the quality competency, standards and their
impact on public health must be observed. Quality systems must be put in place in order to
support the development, manufacturing and monitoring of medicines in order to comply with
regulations. Adhering to standard operation procedures and describing validation studies
emphasizes the importance of the medicine in order to minimize risk while maximizing benefits.
Strategy recognizes the factors that influence national and international regulatory decisions
and allow the development of product as well as market advertisement. The strategy
competency emphasizes the medicine development to support the business objectives by
preemptively identifying risks and describing plans for marketing and development of medicines
within a predetermined time frame.
All stakeholders within clinical research have different roles and responsibilities when it comes
to sharing and analyzing clinical data. In addition, the perspectives of these different
stakeholders have differing ideas as to maximize benefits while minimizing risks. Participants for
clinical research must be willing and have received appropriate information about the trials
being done before informed consent can be achieved. The most important thing a stakeholder
can provide a participant with is trust, and that trust has to be maintained across all
stakeholders in order to ensure the best clinical data is collected. The consent process between
stakeholders and clinical research participants is the best way to keep the dialogue of research
transparent and ensure that the participants will be protected.
Each medicine device that can be prescribed for human use has to be approved by regulatory
authorities. The pharmaceutical industry has an important role within clinical research in that
they conduct clinical trials to evaluate the safety and efficiency of their drugs and medicines.
These clinical trials are important in that these drugs can be made within regulatory guidelines
for approval for use en-masse. The role of the government in clinical research is to build trust
between clinical research trials and the public. They implement safety measures to protect
participants in those clinical trials and hold researchers accountable for breaches in research
conduct. Academia provides access to participants as well as those with experience with clinical
research to conduct clinical trials. Additionally, academia can provide funding for clinical
research trials and are often motivated by public health concerns or by individual interests in
medical products. Clinical sites serve both participants and the sponsors of a clinical research
trial. They provide options for participants to improve their knowledge of the medical device
being researched and how to better take care of themselves for future research or for their own
benefit. Clinical sites also provide safe sites for where the devices being researched can be
tested and then report the findings to the appropriate regulatory authority.
Works Cited
CORE COMPETENCIES
. (n.d.). Agreglobal; Association of Graduate Regulatory
Educators. Retrieved May 19, 2022, from https://www.agreglobal.org/core-competencies
The Roles and Responsibilities of Stakeholders in the Sharing of Clinical Trial Data.
(2015). In
www.ncbi.nlm.nih.gov
. National Academies Press (US).
https://www.ncbi.nlm.nih.gov/books/NBK286000/
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