MASTERSKILL UNIVERSITY COLLEGE OF HEALTH SCIENCES PREPARED BY: BY: MENAGA RAVENDRAN 01-20080501-200805-00297 YAMUNAH LACHUMANAN 01-20080501-200805-00141 TAMILARASI

G.NATARAJAH 01-20080501-200805-00055 LEKA PUSHPANATHAN 01-20080501-200805-00254

RISK MANAGEMENT AND PHARMACEUTICAL IN INDUSTRY 2

RISK MANAGEMENT IN THE INDUSTRY

 In

fact,more and more medical device,biotechnology and pharmaceutical firms employrisk management,which is nothing more than a holistic way of blending insurance with non-insurance techniques to reduce uncertainly and the financial consequences of loss.Life sciences companies can also view risk management as a toolbox of techniques.There are four classic risk management techniques:

Control  Retention  Transfer  avoidance



  

CONTROL aims to reduce the frequency or severity of accidents.Loss control techniques benefit medical device,biotehcnology and pharmaceutical companies in three ways. First,to the extent that safety measures prevent losses,they save money and loss of the or fimb. Second insurance companies offer lower premiums to firms that can demonstrate that they have a well thought-out safety plan. Third ,many insurance companies my provide even further,deeper discounts to firms which have adopted loss control and safety measures,they are typically less than the costs of a single accidents. RETENTION is a conscious decision to self-fund partial or all losses without transferring the risks to an insurer or another entity.While some large life sciences technology firms establish large and ophisticated self-insuranceprograms,many smaller enterprises lack the financial wherewithal or risks appetite to seriously consider this.On the other hand,there are other ways tahat smaller-sizedfirms can consider retention as an potion.For example,medical device,biotechnology and pharmaceutical firms can identify certain small types of losses and opt not to purchase insurance foer them.One example migth be breakage of glass or rental car reimbursement for company-owned vehicles.These types of losses involve low dollar figures,and some firms may feel comfortable in funding for these types of contingencies out of regular operating funds.

TRANSFER as a term implies ,involves shifting the financial consequences of loss to another entity.The most obvious example of tansfer is the insurance transaction.The company pays money premium to a professional riskbearer,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.Insurance is acommon risks management technique,but it works best and is most cost effective when integrated with avoidance,control and retention.Risks Management is more than simply buying insurance! AVOIDANCE ,as a term implies,means shying away from an activity because of its potential for losses.For example,due to liability lawsuits,there are now few companies which manufacture Intrauterine devices.Some device companies have found these lawsuits so prevalent and costly that they made a conscious dicision to stay out of these product lines.Life sciences Technology firms can consider avoidance as arisk management tool,by deciding to avoid functions or activities which may entail a risk of severe loss.

GLP ,GMP & GCP



Every product and every process has an associated risk.(cabaran)Every enterprise should have a methodology(cabaran) for identifying (mengenal pasti)and evaluating (menilai)the risks it faces and it should have a process for generating intervenion plans(strategi) to reduce the risks to an acceptable level.This process is generally 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 risks.For example Good Laboratory Practice (GLP),Good Manufacturing Practice(also referred to as cGMP or current Good Manufacturing Practice )and Good Clinical Practice (GCP).

Good Laboratory Practice generally refers to a system of management controls for laboratories and research organisations to ensure the consistency and reability of results.

The Good Laboratory Practice

y

These principles of good laboratory practice should be applied to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals.These test items are frequently synthetic chemicals, but may be of natural or biological origin and, in some circumstances, may be living 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. Non-clinical health and environmental safety studies covered by the principles of good laboratory practice include work conducted in the laboratory, in greenhouses, and in the field.

Good Laboratory Practice (GLP) embodies a set of principles provides a framework within which laboratory studies are planned,performed,monitored,recorded, reported and archived.These studies are undertaken to generate data by which the hazards and risks to users,consumers and third parties ,including the environment ,can be assessed for pharmaceuticals (only preclinical studies),agrochemicals,cosmetics ,food additives ,feed additives and contaminants ,novel foods,biocides,detergents etc.GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.

Good Manufacturing Practice or GMP (also referred to as cGMP or current Good Manufacturing Practice)is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods,pharmaceutical products ,and medical devices.

GMP is designed to help assure the quality of drug products by ensuring several key attributes ,including correctness and legibility of recorded manufacturing and control documentation.Data transfers must be performed in specific ways to avoid mistakes (e.g.writing down a reading on a balance and requiring a second person to also check the balance reading to assure accuracy).Methods have been developed to make this process easier (e.g.links between equipment and central data storage facilities for direct tansfer of important data).

GMP takes the holistic approach of regulating the manufacturing and laboratory testing environment itself.An exremely important part of GMP is documentation of every aspect of the process,activities ,and operations involved with drug and medical device manufacture.If the documentation showing how the product was made and tested is not correct and in order,then the product does not meet the required specification and is considered contaminated.

The Good Clinical Practice

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 mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

 Good

Clinical Practice guidelines include protection of human rights as a subject in clinical trial.It also provides assurance of the safety and efficacy of the newly developed compounds. Good Clinical Practice guidelines include standards on how clinical research trials should be conducted,define the roles and responsibilities of clinical trial sponsors,clinical research investigators,and monitors.In the pharmaceutical industry monitors are often called Clinical Research Associates.