From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories 12
a prospective employee with a mathematical background or at least with an intuitive
understanding of statistical methods as they relate to problem solving and decision
making. Statistical techniques are invaluable for describing and collecting data, chart-
ing, forecasting and summarizing clinical results. A valuable regulatory professional will
learn or know how to interpret and present biostatistics. This is particularly important
when reviewing and summarizing published scientific articles or laboratory reports for
submission to FDA or other regulatory bodies. All regulatory personnel should be familiar
with the null hypothesis, significance levels and power and confidence intervals, but the
actual application of statistics is best left to trained statisticians. Books that have proven
to be helpful resources to foster an understanding of biostatistics and medical literature
include Statistics Without Tears,13 Basic Medical Statistics,14 Biomedical Bestiary15 and Studying
a Study and Testing a Test.16 Another useful resource is a series of videotapes on “Statistics
for Problem Solving and Decision Making” by Dr. Stuart Hunter and offered by the
University of Kentucky Continuing Education Department.
Negotiating Skills
Turning a potential conflict into a win/win situation requires well-developed negotiat-
ing skills. Much of the regulatory job involves negotiation and compromise, whether it is
through interaction with FDA, dialog with a Notified Body or interdepartmental resource
allocation meetings. The best regulatory professionals will be able to analyze the other
parties’ needs be able to plan, organize and execute a strategy of presenting their position
and be able to defuse objections by appropriate questioning techniques. Many seminars
are offered to help employees improve their negotiation skills.
Personality Type
The overall personality of an individual can be a clue to the person’s aptitude for a
regulatory career. A firm but friendly demeanor goes a long way when interacting with
a multidisciplinary group. In addition, a practical approach to life will serve well in the
regulatory field. Individuals must have the intelligence to understand the regulations and
apply them to their specific industry. But they must also be pragmatic in their applica-
tion of those regulations, assuring compliance without creating an environment that
stifles the continuing operation of the company. Research and development professionals
need the freedom to create new products without the regulatory department applying
handcuffs. And, those new products need to move into the market expeditiously, without
unnecessary delays caused by overly cautious regulatory personalities. Yet, at other times,
the regulatory professional may need to be the voice of caution, requiring adequate or
additional testing prior to product release to assure product safety and efficacy. With an
understanding of the litigation process and an ever-present awareness of the company’s
responsibility to society, the regulatory professional must provide a careful balance
between pragmatism and idealism.
Conclusion
Are good regulatory employees made or born? The authors believe that good regulatory
professionals are born with certain basic abilities and personality traits such as curiosity,
perseverance and practicality. The supervisor should select for these traits when hiring a
new employee. However, the vast majority of skills and techniques used in performing
the regulatory function can be learned using resources such as those listed in this article.
With programs of regular self-improvement through continuing education adding to the
employee’s knowledge, expertise and ability to solve problems, most regulatory profes-
sionals will probably claim to be ...self-made.
a prospective employee with a mathematical background or at least with an intuitive
understanding of statistical methods as they relate to problem solving and decision
making. Statistical techniques are invaluable for describing and collecting data, chart-
ing, forecasting and summarizing clinical results. A valuable regulatory professional will
learn or know how to interpret and present biostatistics. This is particularly important
when reviewing and summarizing published scientific articles or laboratory reports for
submission to FDA or other regulatory bodies. All regulatory personnel should be familiar
with the null hypothesis, significance levels and power and confidence intervals, but the
actual application of statistics is best left to trained statisticians. Books that have proven
to be helpful resources to foster an understanding of biostatistics and medical literature
include Statistics Without Tears,13 Basic Medical Statistics,14 Biomedical Bestiary15 and Studying
a Study and Testing a Test.16 Another useful resource is a series of videotapes on “Statistics
for Problem Solving and Decision Making” by Dr. Stuart Hunter and offered by the
University of Kentucky Continuing Education Department.
Negotiating Skills
Turning a potential conflict into a win/win situation requires well-developed negotiat-
ing skills. Much of the regulatory job involves negotiation and compromise, whether it is
through interaction with FDA, dialog with a Notified Body or interdepartmental resource
allocation meetings. The best regulatory professionals will be able to analyze the other
parties’ needs be able to plan, organize and execute a strategy of presenting their position
and be able to defuse objections by appropriate questioning techniques. Many seminars
are offered to help employees improve their negotiation skills.
Personality Type
The overall personality of an individual can be a clue to the person’s aptitude for a
regulatory career. A firm but friendly demeanor goes a long way when interacting with
a multidisciplinary group. In addition, a practical approach to life will serve well in the
regulatory field. Individuals must have the intelligence to understand the regulations and
apply them to their specific industry. But they must also be pragmatic in their applica-
tion of those regulations, assuring compliance without creating an environment that
stifles the continuing operation of the company. Research and development professionals
need the freedom to create new products without the regulatory department applying
handcuffs. And, those new products need to move into the market expeditiously, without
unnecessary delays caused by overly cautious regulatory personalities. Yet, at other times,
the regulatory professional may need to be the voice of caution, requiring adequate or
additional testing prior to product release to assure product safety and efficacy. With an
understanding of the litigation process and an ever-present awareness of the company’s
responsibility to society, the regulatory professional must provide a careful balance
between pragmatism and idealism.
Conclusion
Are good regulatory employees made or born? The authors believe that good regulatory
professionals are born with certain basic abilities and personality traits such as curiosity,
perseverance and practicality. The supervisor should select for these traits when hiring a
new employee. However, the vast majority of skills and techniques used in performing
the regulatory function can be learned using resources such as those listed in this article.
With programs of regular self-improvement through continuing education adding to the
employee’s knowledge, expertise and ability to solve problems, most regulatory profes-
sionals will probably claim to be ...self-made.