Main Subject - Business

The key to a company’s credibility lies in its ability to communicate. Although media training generally focuses on speaking to the press, the same techniques can be us

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

ed to increase effective communication between upper management and the rest of the company’s employees and between the company and its customers.

In times of crisis, t

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

Examples of combination products may in

is communication becomes more important than ever. To paraphrase a former General Electric slogan, in times of crisis, credibility is our most important product. Consist

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

ntly, executive and crisis response teams that participate in media training exercises on a regular basis inform and reassure the public better than the untrained.

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

ng>Maintaining Credibility The following media training tips provide a guideline for planning for, dealing with, and coming away from a crisis with your repu

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

Combination pro

tation largely unscathed and perhaps even enhanced.

Plan ahead. Before a crisis occurs, know who will be in charge of what, and have a centralized hea

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

quarters established. Many organizations should have a second designated crisis headquarters location in the event the first is unusable. Update emergency contact lists

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

requently and make sure that whoever would need to be reached in a crisis can be reached quickly. A chaotic situation means that it will take far longer for you to gath

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

r the information you’ll need to communicate with the public.

Gather information. When crisis hits, gather as much information as possible, as quickly

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

as possible. What happened? Where? Has anyone been injured or killed? These are the questions that you’ll be asked by reporters, family members and employees. Know

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

what you’ll tell them.

Communicate early and often. Make a statement as soon as you can – but take the time to get organized first. Communicate frequ

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

Following aspects would a

ntly, even if it’s only to say “We don’t have anything further at the moment, but we will let you know as soon as we do.” Don’t treat questions as an annoyance. Convey

dd to the challenges in developing combination products:

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

concern and a desire to keep everyone in the loop. People are more apt to trust an “I don’t know” than they are to trust silence. Communicate directly with t

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

hose affected. While the public at large may have an interest in what’s going on, the people directly affected by the crisis need a more personalized approach.

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

It’s not fair for employees to find out about their own lay-off on the evening news, or have to consult a web site to find out if a family member has been injured.

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

ong>Remember that the show must go on. Even though you’re dealing with a huge problem now, your organization’s operations still need to be attended to. Bills

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

Professional from academic institutions, pharmaceutical industries, health care indust

eed to be paid, clients need to be contacted, and employees need to be given guidance. It’s essential that you keep your day-to-day activities as close to normal as pos

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

sible. The crisis will pass, but the everyday needs of your business will still be there.

Run practice drills often. Once you’ve established a plan an

.

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

process for dealing with a crisis, you should put that plan into action as soon as possible. Conduct mock training drills to “shake down” the plan and see what needs to

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

Companies that provide selfless information through particip

be improved. Too often crisis plans get put on a shelf and are forgotten. Keep your executives and crisis team sharp, so that if a crisis does happen, you’ll be prepared

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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