Main Subject - Business

The term crisis management has different connotations. In this article, I will try to provide pointers that can be used in most situations:

Is

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

It A Crisis In The First Place?:

This question is important to ask, as there are many situations that go wrong because the right person to han

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

Examples of combination products may in

le it is not around. You may be in charge of a project until your supervisor comes back and are unable to contact him during a crisis. You hav

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

to make your own decisions in his absence and your action is dependent on the level of authority given.

The Big Picture:

It is not easy to ha

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

dle a crisis if you are not aware of the all the facts. If your role is a leader, you have to be detached from the emotional side of the crisis

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

Combination pro

and rationally take stock of how to move on. Again, this is not as easy as it sounds as you may have long-time colleagues who are involved in t

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

is crisis.

The Relevant Team:

It is important to be able to meet up with the relevant team to discuss about the situation. This is to ensure

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

hat the team is able to analyse and make a united stand about handling this crisis. This team should also comprise of the authorities, if the c

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

isis is serious.

The Timeline:

You must construct a timeline and ensure that each process scenario is highlighted. This practice will be a ch

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

ck to prevent your team from spending too much time in one aspect of handling the crisis.

Procedural Manual:

Is there an organizational situat

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

onal manual that you can use for this situation? Are you able to recollect the tips that were given to you when you participated in a mock dril

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

Following aspects would a

l?

External Experts:

You should get external experts to access the situation if the crisis is totally unanticipated. However, you must have h

dd to the challenges in developing combination products:

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

d a close-door meeting with your inner circle. This is essential, as you do not want to unnecessarily reveal confidential information to extern

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

l parties.

Speaking To The Media:

It is important to prepare a press kit-which provides a full detailed report about the crisis. If you are c

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

mfortable to conduct a press interview, you have to ensure that you have the full details first.

Your Communication Style:

You have to ensure

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

hat your communication style is in sync with the crisis. Remember to be forthcoming with reliable information and try not to speculate. This w

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

Professional from academic institutions, pharmaceutical industries, health care indust

ll also ensure that the victims’ immediate families do not overly worry. It will also not help if you come across as very emotional in the medi

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

as you want to communicate that your organization has everything under control.

Beyond Your Control:

If the crisis involves the loss of lives

.

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

it is not unthinkable that your credibility and organisation’s reputation is put into question. Assuming that the crisis was beyond your organ

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

Companies that provide selfless information through particip

sation’s control, you have to stick to your best judgement and not be led into a debate that may open your organisation to possible legal action

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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