Risk Management in the Industry

8/6/2019 Risk Management in the Industry

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MASTERSKILLMASTERSKILL UNIVERSITY COLLEGEUNIVERSITY COLLEGE OF OF HEALTHHEALTH

SCIENCESSCIENCES

PREPAREDPREPARED BYBY::

MENAGA RAVENDRANMENAGA RAVENDRAN

0101--200805200805--0029700297

YAMUNAHYAMUNAH LACHUMANANLACHUMANAN0101--200805200805--0014100141

TAMILARASI G.NATARAJAHTAMILARASI G.NATARAJAH

0101--200805200805--0005500055

LEKA PUSHPANATHANLEKA PUSHPANATHAN

0101--200805200805--0025400254



RISK MANAGEMENTRISK MANAGEMENTANDAND

PHARMACEUTICALPHARMACEUTICAL

ININ

INDUSTRY 2INDUSTRY 2



CONTROL aims to reduce the frequency or sever ity of accidents.Loss control techniques benef it medical device,biotehcnology andphar maceutical companies in three ways.

Fi

r s

t,to the extent tha

tsa

fetym

eas

ures

prevent loss

es

,theysa

vem

oneyand loss of the or f imb.

Second insur ance companies offer lower premiums to f ir ms that candemonstr ate that they have a well thought-out safety plan.

Third ,many insur ance companies my provide even further,deeper discounts to f ir ms which have adopted loss control and safetymeasures,they are typically less than the costs of a single accidents.

RETENTION is a conscious decision to self-fund partial or all losses without tr ansferr ing the r isks to an insurer or another entity.Whilesome large life sciences technology f ir ms establish large andophisticated ́ self-insur anceµprogr ams,many smaller enterpr ises lack the f inancial wherewithal or r isks appetite to ser iously consider this.On

the other hand,there are other ways tahat smaller-sizedf ir ms canconsider retention as an potion.For example,medicaldevice,biotechnology and phar maceutical f ir ms can identify certainsmall types of losses and opt not to purchase insur ance foer them.Oneexample migth be breakage of glass or rental car reimbur sement for company-owned vehicles.These types of losses involve low dollar f igures,and some f ir ms may feel comfortable in funding for these types

of contingencies out of regular oper ating funds.



TRANSFER as a ter m implies ,involves shifting the f inancial

consequences of loss to another entity.The most obvious

example of tansfer is the insur ance tr ansaction.The company

pays money premium to a professional r isk bearer,e.g an

insurer.The insurer exchanges a promise to pay in return for a

stream of premium.The premiums of the many aim to fund the

losses of the few.Insur ance is acommon r isks management

technique,but it wor ks best and is most cost effective when

integr ated with avoidance,control and retention.Risks

Management is more than simply buying insur ance!

AVOIDANCE ,as a ter m implies,means shying a way from an

activity because of its potential for losses.For example,due to

liability la wsuits,there are now few companies which

manuf acture Intr auter ine devices.Some device companies havefound these la wsuits so prevalent and costly that they made a

conscious dicision to stay out of these product lines.Life sciences

Technology f ir ms can consider avoidance as ar isk management

tool,by deciding to avoid functions or activities which may entail

a r isk of severe loss.



GLP ,GMP & GCPGLP ,GMP & GCP Every product and every process has an associated

risk.(cabaran)Every enterpr ise should have a methodology(cabaran)

for identifying (mengenal pasti)and evaluating (menilai)the r isks it

f aces and it should have a process for gener ating intervenion

plans(strategi) to reduce the r isks to an acceptable level.This process

is gener ally referred to as a Risk Management Plan(RMP).

There are a few of systems of management controls which are

important for identifying and evaluating the r isks.For example Good

Labor atory Pr actice (GLP),Good Manuf actur ing Pr actice(alsoreferred to as ¶cGMP· or current Good Manuf actur ing Pr actice )and

Good Clinical Pr actice (GCP).

Good Laboratory Practice gener ally refer s to a system of

management controls for labor ator ies and research organisations toensure the consistency and reability of results.



The Good Labor atory Pr acticeThe Good Labor atory Pr acticey These principles of good laboratory practice should be applied

to the non-clinical safety testing of test items contained inphar maceutical products, pesticide products, cosmetic

products, veter inary drugs as well as food additives,

feed additives, and industr ial chemicals. These test

items are frequently synthetic chemicals, but may be of

natural or biological origin and, in some circumstances, may beliving organisms. The purpose of testing these test items is to

obtain data on their properties and/or their safety with

respect to human health and/or the environment.

y Non-clinical health and environmental safety studies covered by

the principles of good laboratory practice include work

conducted in the labor atory, in greenhouses, and in the

f ield.



Good Labor atory Pr actice (GLP) embodies a set of

pr inciples provides a fr amewor k within which labor atory

studies are planned,performed,monitored,recorded, reported

and archived .These studies are undertak en to gener ate data

by which the hazards and r isks to user s,consumer s and third

parties ,including the environment ,can be assessed for

phar maceuticals (only preclinical

studies),a grochemicals,cosmetics ,food additives ,feed additivesand contaminants ,novel foods,biocides,detergents etc.GLP

helps assure regulatory author ities that the data submitted

are a true reflection of the results obtained dur ing the study

and can therefore be relied upon when making r isk/safety

assessments.



y GMP takes the holistic approach of regulating

the manufacturing and laboratory testing environment itself.An exremely importantpart of GMP is documentation of every aspect of the process,activities ,and

operations involved with drug and medicaldevice manufactur e.If the documentationshowing how the product was made and tested is not correct and in order,then theproduct does not meet the required specification and is considered contaminated.



The Good Clinical Pr acticeThe Good Clinical Pr actice

y The objective of this ICH GCP Guideline

is to provide a unified standard for the

European Union (EU), Japan and the

United States to facilitate the mutualacceptance of clinical data by the

regulatory authorities in these

jurisdictions.



Good Clinical Practice guidelines include

protection of human r ights as a subject inclinical tr ial.It also provides assur ance of the

safety and eff icacy of the newly developed

compounds. Good Clinical Pr actice guidelines

include standards on how clinical researchtr ials should be conducted,def ine the roles

and responsibilities of clinical tr ial

sponsor s,clinical research investigator s,and

monitor s.In the pharmaceutical industrymonitor s are often called Clinical Research

Associates.

Risk Management in the Industry

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