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8/6/2019 Risk Management in the Industry
http://slidepdf.com/reader/full/risk-management-in-the-industry 1/13
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
8/6/2019 Risk Management in the Industry
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RISK MANAGEMENTRISK MANAGEMENTANDAND
PHARMACEUTICALPHARMACEUTICAL
ININ
INDUSTRY 2INDUSTRY 2
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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.
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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.
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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.
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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.
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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.
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8/6/2019 Risk Management in the Industry
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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.
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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.
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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.