Principles of Discovery of Medicines and Development Planning Question Answer 2022

Running head: PRINCIPLES OF DISCOVERY OF MEDICINES & DEVELOPMENT
PLANNING
Principles of Discovery of Medicines & Development Planning
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PRINCIPLES OF DISCOVERY OF MEDICINES & DEVELOPMENT PLANNING1
1. Relationship between pharmacovigilance, clinical safety and regulatory affairs
Pharmacovigilance and its relation with clinical safety
Pharmacovigilance (PV) can be referred to as the activities and science related to the
assessment, understanding, detection and prevention of the critical impacts or other medicine-
related issues (Maigetter et al. 2015). It plays a significant role in healthcare system by means
of discovery, assessment and monitoring of the interactions among the drugs and their impacts
among the human beings. WHO has defined the term as “the science and activities relating to
the detection, assessment, understanding and prevention of adverse effects or any other drug-
related problem” (Raza and Jamal 2015) Its aim is to bolster the safety of patient in terms of
medicine usage by means of providing a system for collecting, distributing and assessing the
drug safety.
Clinical safety on the other hand is a pharmacological science that is related to the
collection, detection, assessment, monitoring and prevention of the adverse reactions of drugs.
It is to mention that both Pharmacovigilance and clinical safety refer to the same function of
gathering and reporting the reactions of drugs in human beings. However, the main difference
lies among them is in terms of the values of the data that are generated. It is to mention that in
the Pharmacovigilance model, more complicated and larger datasets are analysed. This further
generates significant insight into the way drugs perform in the real world. Valuable data are
generated on the basis of how the medicines are performing in the patient sub-populations and
across the states of the diseases (Zhang and Meltzer 2016). On the other hand, in the clinical
safety, the data are collected during the clinical trials and they are reported on in the post
marketing environment. The information is then used by the regulatory agencies for making
decisions regarding which drug to be registered. With the same, it is also to note that like the

PRINCIPLES OF DISCOVERY OF MEDICINES & DEVELOPMENT PLANNING2
clinical safety, Pharmacovigilance was comprises of the safety operations, agreements on
exchange of safety data, risk management etc.
Ways in which Pharmacovigilance, clinical safety and regulatory affairs are linked
Furthermore, it is to mention that like Pharmacovigilance and clinical safety, regulatory
affairs too is an essential part of the healthcare industry. According to Hernandez et al. (2017),
regulatory affairs are focused on the development of the global regulatory strategies for the
new and the novel products, collaboration with the other regulatory bodies all around the world
for setting different standards for the new technologies, support the activities on clinical
development, filling-up of the regulatory related submissions and ensure the regulatory
compliance all through the product life cycle. According to Walker et al. (2016), the regulatory
specialists are expected for being highly passionate about the efficiency and safety of the
medical and drug devices. They play a very important part in the process of communication
between their company and the different regulatory bodies like the FDA, EMA etc. It is to
mention that regulatory affairs are also known as government issues. There is an intersection in
between Pharmacovigilance and regulatory affairs and it can be seen in a growing need for the
exchange of information, that is, for the “Risk Management Plan (RMP), Pharmacovigilance
System Master File (PSMF) and the Summary of Product Characteristics (SmPC)” etc.
The regulatory affairs are involved with about each and every aspect of development of
drugs and medicines by means of commercialisation. They are also involved in the activities of
post-commercialisation. For instance, the activities that comprise of the expansion of the data
and information for modifying the present label on the marketed product or the submissions for
the new indicators or the Pharmacovigilance are part of the regulatory affairs. It is also related
to the clinical safety. Krageloh et al. (2018) in this context have claimed that the regulatory
affairs prevail for the methods of updating the information of the product and the