3 Clinical Research

Education and Training

for Biopharmaceutical Staff

Peter Marks

3.1 Introduction

The biopharmaceutical industry is a highly regu-
lated industry where many of the activities and
tasks performed by company staff are defined by
regulations and guidelines issued by international
regulatory authorities. The training requirements
for clinical staff of pharmaceutical companies or
sponsors can be relatively well defined.
The International Conference on Harmonization
(ICH) Guideline for Good Clinical Practices
(GCP), for example, describes a minimum stan-
dard for the ethical and scientific standards for
designing, conducting and reporting clinical
research. The ICH GCP Guideline is the unified
standard for the European Union (EU), Japan and
the United States to facilitate mutual acceptance of
clinical data. The ICH GCP Guideline, together
with other ICH Guidelines, provides operational
definitions of the core competencies needed by
clinical staff to conduct world-class clinical
research.
One of the principles of ICH GCP is that ‘each
individual involved in conducting a trial should be
qualified by education, training and experience to
perform his or her respective task(s)’. Specifically,
regarding the selection and qualifications of moni-
tors, the ICH GCP Guideline states that ‘monitors

should be appropriately trained and should have

the scientific and/or clinical knowledge needed to

monitor the trial adequately’. Most major pharma-

ceutical firms have always had varying degrees of

in-house education and training for staff, supple-

mented (as appropriate) by external workshops,

courses and training meetings. The ICH GCP

Guidelines help formalize the desired elements of

education programs to comply with current GCP

requirements.

3.2 What is a competency-based

training program?

Few people come to the pharmaceutical industry

from academia and health-related positions with

the requisite knowledge and skills necessary to

plan, conduct and report clinical research to reg-

ulatory authority standards. This knowledge and

skill usually need to be provided by sponsors to all

levels of new staff by the way of in-house training.

One approach to education and training in

the industry is what is called ‘competency-based

training’. A competency is a skill, knowledge or

behavior required to undertake effectively the tasks

and responsibilities for which an individual is

responsible.

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
#2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9