Risk Management Principles for Devices and Pharmaceuticals
3
Introduction
The role of risk management in the drug develop-
ment and postmarket environment is to optimize
user benefits while minimizing risk and maintain-
ing appropriate access. Managing risk involves
many diverse individuals, including scientists,
regulators, policymakers, physicians, healthcare
providers, and patients. In early development,
nonclinical study data are used to initiate the
development of a human testing safety profile.
During Phase 1 development, risks are managed
at the individual patient level through careful
monitoring and observation. As the drug pro-
gresses further into Phase 2 and 3 clinical trials,
safety data are aggregated to assess risk at a
population level. Following approval, the popula-
tion exposed to the drug becomes more diverse,
expanding the breadth and complexity of data
and information on the drug’s benefits and risks.
The science and process of risk manage-
ment have evolved over time. This evolution is
reflected in the activities conducted as well as
the governing regulations and guidelines. Risk
management is becoming increasingly complex,
with the globalization of requirements, increased
availability of potential data sources through
advanced technology, digitization, and changes
to the healthcare delivery system. The complexity
and nature of clinical development and postmar-
ket experience require a proactive, systematic, and
scientific approach to measuring or assessing risk
and developing strategies to manage or mitigate it.
Risk Management Concepts
Pharmacovigilance Overview
Pharmacovigilance (PV) refers to scientific
activities relating to the detection, assessment,
understanding, and prevention of adverse effects
or any other drug-related problem.1 One PV
objective is to maintain a current safety profile,
which includes information regarding the drug’s
known and potential risks in the context of its
efficacy information, forming the benefit-risk
profile under which the product is used. When
discussing risk, it is important to differentiate
between harm (the damage resulting from taking
the drug) and risk (the probability that harm
could result from taking the drug).
Safety information is collected to monitor
and maintain biopharmaceutical products’ safety
profile. In the US and many other countries,
Risk Management
Regulations in the US
Brande Yaist, MS Debra Porter, MS Debashish Dey, MD,
PhD, MPH and Nayan Achayara MBBS, MRCP, MFPM
1
3
Introduction
The role of risk management in the drug develop-
ment and postmarket environment is to optimize
user benefits while minimizing risk and maintain-
ing appropriate access. Managing risk involves
many diverse individuals, including scientists,
regulators, policymakers, physicians, healthcare
providers, and patients. In early development,
nonclinical study data are used to initiate the
development of a human testing safety profile.
During Phase 1 development, risks are managed
at the individual patient level through careful
monitoring and observation. As the drug pro-
gresses further into Phase 2 and 3 clinical trials,
safety data are aggregated to assess risk at a
population level. Following approval, the popula-
tion exposed to the drug becomes more diverse,
expanding the breadth and complexity of data
and information on the drug’s benefits and risks.
The science and process of risk manage-
ment have evolved over time. This evolution is
reflected in the activities conducted as well as
the governing regulations and guidelines. Risk
management is becoming increasingly complex,
with the globalization of requirements, increased
availability of potential data sources through
advanced technology, digitization, and changes
to the healthcare delivery system. The complexity
and nature of clinical development and postmar-
ket experience require a proactive, systematic, and
scientific approach to measuring or assessing risk
and developing strategies to manage or mitigate it.
Risk Management Concepts
Pharmacovigilance Overview
Pharmacovigilance (PV) refers to scientific
activities relating to the detection, assessment,
understanding, and prevention of adverse effects
or any other drug-related problem.1 One PV
objective is to maintain a current safety profile,
which includes information regarding the drug’s
known and potential risks in the context of its
efficacy information, forming the benefit-risk
profile under which the product is used. When
discussing risk, it is important to differentiate
between harm (the damage resulting from taking
the drug) and risk (the probability that harm
could result from taking the drug).
Safety information is collected to monitor
and maintain biopharmaceutical products’ safety
profile. In the US and many other countries,
Risk Management
Regulations in the US
Brande Yaist, MS Debra Porter, MS Debashish Dey, MD,
PhD, MPH and Nayan Achayara MBBS, MRCP, MFPM
1