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Recent man-made and natural disasters, including terrorist attacks, the Indian Ocean tsunami and the threat of pandemic flu, all serve to highlight the critical need for public and commercial organisations alike to address Business Continuity Planning (BCP). While the UK

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

Government’s Civil Contingencies Act stipulates the requirement for thorough Business Continuity Management (BCM), and the new BSI standard (BS25999) will support the process of implementing best practice, it will not overcome some of the implicit major BCP issues. Arguab

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

Examples of combination products may in

y the most significant of these is understanding complexity – comprehending the interdependencies and interactions that define the business-critical processes of modern organisations; ensuring stakeholders are fully trained and aware of their roles and responsibilities, a

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

nd managing the myriad of policies that directs your BCP.

Effective BCP must be informed by a clear understanding of the critical processes that an organisation must conduct in order to achieve its business aims and key supporting objectives. To ensure processes are adeq

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

ately protected, Business Continuity planners must have a clear and comprehensive understanding of all business-critical elements in the organisation, including their relationships, inter-dependencies and relative priority/criticality to the business, so risks can be iden

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

Combination pro

ified, assessed and appropriately planned for. Incomplete Business Continuity Analysis would leave the organisation vulnerable to a critical failure.

The main purpose of BCM is to develop the ability to continue your business-critical activities in the event of a pre-def

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

ined disaster scenario occurring. It is essential, therefore, to ensure that your organisation has an effective BCP in place and that any critical third party suppliers also have adequate BCPs to ensure continuation of service to a defined (probably reduced) Service Level

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

Agreement. Once you have addressed the potential threats to your own organisation, you do not want suppliers representing weak links in you Business Continuity ‘chain’.

Without a clear understanding of what your business-critical processes are, or the ability to easily i

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

entify the systems, infrastructure elements and people upon which these processes depend, how can you assess how a particular threat will impact them? If you cannot be confident that you have fully understood these areas, how can you be sure that you have not overlooked a

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

business-critical element in your planning process and, therefore, that the Business Continuity and Disaster Recovery plans you have developed will be truly effective? The answer is you can’t!

Enterprise Modelling (EM) is now a recognised technique for making complexity

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

more understandable, by generating an exploitable model of your organisation’s ‘business-critical architecture’. It provides a clear and understandable structured graphical visualisation, enhanced by supporting textual information, of the vital business interactions of yo

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

Following aspects would a

r critical staff, assets and processes, the risks that threaten them, and the plans that can be brought to bear to protect them. This will facilitate identification, analysis and understanding of the business-critical aspects of the organisation, and the relationships and

dd to the challenges in developing combination products:

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

dependencies that exist between them. EM can also support incident management and what-if scenario analysis, and help identify BCM training needs and how they are delivered.

A further valuable by-product of using the EM approach is, in taking a group-wide view of all bu

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

iness-critical aspects, EM will identify any key areas of vulnerability, as well as anomalies or duplications of effort, which, once rectified, will improve efficiency.

There is no point spending all the time, effort and cost developing a BCP unless it is effectively com

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

unicated to employees, key partners and suppliers, and possibly customers. BCM and BCP are therefore not one-off processes; plans must be distributed to all relevant parties, be read and understood by them, be readily available and practiced at appropriate intervals, and

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

kept up-to-date and relevant to the business.

While responsibility for Business Continuity should lie at all levels within an organisation, ultimate responsibility for protecting shareholder value and the future viability of the organisation lies with the Board of Manage

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

Professional from academic institutions, pharmaceutical industries, health care indust

ent. The Board must demonstrate that its Business Continuity and Disaster Recovery plans are properly managed, i.e., distributed, practiced on a regular basis and finally, maintained as relevant to the business as it changes.

The threats posed by humans and nature are ev

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

r with us and, some would say, increasing. In order to counter this, in-depth Business Continuity Planning and Management will be critical. Underpin

.

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

ning these plans with Enterprise Modelling can deliver a comprehensive, accurate and coherent model of an organisation’s business-critical elements, and enable managers to produce more effective BCP and more easily identify and address specific areas in both crisis and no

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

Companies that provide selfless information through particip

mal operations.

The addition of a computer-based Policy Management System automates the distribution and tracking of your BCM policy and plans, and further, provides the Board with demonstrable evidence that they are paying due heed to Corporate Governance and Compliance

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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