Advice You - Business

All projects are essential and every project has its own risk elements. Commencing from initiation to post completion of the project, the degree of risk grows within, as does the haze of uncertainty, thus proper project risk management can make a difference.

Risk inevitably co

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

mes with any project. It resides in the project as a contrary and hinders as an adversary. Enclosed within, the compound constraint of time, budget, workforce and multiple quantifiable and non-quantifiable determinants; a project marches towards its success and the risk factors follow

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

until project execution.

To be precise, “risk” in a project management is the threat or possibility that an action or occurrence will unfavorably affect a project’s potentiality to achieve its objectives. Any counter event and adverse causes that can become an obstacle are ris

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

factors.

However, inside the project management line of attack is the term “risk” this term is considered as a negative component resembling an occurrence that will adversely affect the goal of the project. Nevertheless, in the optimistic and neo project management approach, “risk”

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

an be considered as a prospective occurrence or a productive event; if handled and executed properly it may lead to achieve enhanced objectives, improved and advanced.

Project risk management is the procedure of determining or evaluating risk and developing strategies to manage it

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

and is concerned with identifying risk and putting in place policies to eliminate or reduce these perils.

Project risk analysis is the detection and quantification of these probabilities and collisions of events that may harm the project. The risk analysis process

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

identifies risk in advance, and the risk management process established methods of avoiding these risks thus reducing the impacts that may occur.

Risk Detection

Risk detection is an initial step in the risk management course. As these potential hazards occur causing p

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

oblems in its kinetics there needs to be a plan for identification. To identify these concealed threats at their origin before their occurrences whether they are quantifiable or non-quantifiable is the foremost groundwork; this groundwork is the risk identification course of action.

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

isk detection starts with tracing risk sources as a root cause, and its source branches including internal to external and primary to secondary.

Some of the most common risk detection methods in project risk management are as follows;

1. Objective Oriented Risk Detection

2. Scenari

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

Oriented Risk Detection

3. Taxonomy Oriented Risk Detection

4. Regular Risk Inspection

Risk Evaluation in Project Risk Management

Once the risk detection process is concluded, then they must be evaluated for their latent severity for loss, and its likelihood for hazards. I

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

project risk management, each risk should be exploited independently as they vary from simple to complex results.

Generally, plain risk can easily be quantified, while those risks of probabilities are unfeasible to enumerate; thus in the evaluation process it is significant to take

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

finer presumption to accurately accentuate the implementation of the risk management remedy. Moreover, the primary problem in risk evaluation is lack of statistical information and scientific evidences for determining the pace of risk events that may occur.

Conversely, gauging risk

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

s often quite a complicated process, although numerous formulae are being followed; a popular yet simple formula is;

Project Risk = Accident X (Probability X Impact)

Or

Project Risk = Accident Probability X Accident Impact

Here, risk is directly equivalent to “pro

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ability of accident” multiplied by the “impact of accident”. In opposition, project risk management is less reliant only on the type of formula pursued, but more reliant on the risk occurrence and on how risk management is employed.

However, in general a systematic

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

tactical plan that should be prearranged for risk management is as follows:

Risk: Description of the Actual Risk

Impact: Impact on the Project if the Risk Occurs

Possibility: Possibility of Loss if Risk Occurs

Action: Action Remedy to Reduce the Impact

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

Cost: Cost if the Risk Occurs

Once risk is identified and evaluated, there are four major practices that need to be followed to prevent a failed remedy, they are:

1. Risk Evasion: Avoidance of the Risk Altogether

2. Risk Diminution: Reducing the Degree of Risk thro

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

gh Precaution Measures

3. Risk Retention: Accepting the Degree of Risk with Loss

4. Risk Relocating: Transferring the Risk to Another Party

Hence, in the combat of project risk management etiquette, a precedence procedure should be tracked, whereby risks with the

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

maximum loss and the maximum probability of evils should be handled first; vice versa to those with minimum risk.

Project risk management is the tactic of methodically applying lucrative action for diminishing the effect of hazard to the project. Risks are never fully avoidable due t

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

exterior elements and limitation of financial and practical margins. However, with the acceptance of a certain degree of risk and the arrangements of its counter to tackle it, the risk at hand can be recompensed.

All risks can never be fully avoided or mitigated, therefore all proje

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ts have to accept some level of residual risks, but if the risk is handled with mythological and proficient approach referring to statistically and scientific information then risk rewards.

Project risk management is one single process to manipulate, exploit, and extinct risk.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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