41 Risk Management in Product

Approval and Marketing

Anthony W. Fox

41.1 What is it?

In general terms: Identification and implementa-
tion of strategies to reduce risk to individuals and
populations

For individual products: A plan oriented towards
the known risks of the product, and identifying
methods not only to minimize risk to the indivi-
dualpatient, but also todefinefurther theproduct’s
safety profile as it reaches a wider population.

adapted from remarks by Markku Toivonen

MD PhD (February 2003)

Risk management in product approval and market-
ing is an extension of the practice of pharmacov-
igilance, and translates the observations of that
discipline into actions that reduce clinical hazard.
This is the art and science of getting the right drug
to the right patient at the right time.
Clinical hazard has two aspects. The most
obvious aspect is avoiding the inappropriate expo-
sure of a patient to a potentially harmful drug. But
let us not forget that clinical hazard can also be
created by restrictions on product distribution
channels; if these are too rigourous, then the drug

might never reach a patient who could experience

benefit beyond that from any alternative therapy.

This chapter begins with the regulatory basis for

risk management programs, as far as is needed

beyond the previous chapters on European and

American regulations. Practical examples will

then be considered.

41.2 Regulatory frameworks

Of all areas of regulatory science, the regulations

concerning risk management programs are amongst

the least internationally harmonized. It can be

argued that this is good: as we shall see below,

special risk management programs work best

when tailored to the specific characteristics of the

product, its indicationand the venue of its use.

Flexibility of approach may be required to adapt a

risk management program to different geographical

and cultural contexts, even when the same product

and indication are under consideration.

The ordinary case. All Sponsors/Marketing

Authorization Holders are required to implement

pharmacovigilance programs for all marketed

products. Reports to regulatory authorities of the

findings of these programs are usually required

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