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Advice You - Crisis Communications: Six Steps Toward Readiness
Anyone who has ever been in a crisis knows just how fast things can spin out of control. Once you’re in a crisis, planning is a luxury you can’t afford. Taking proactive steps 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 to safeguard your reputation becomes harder, as you scramble to react to each new revelation or accusation. As a result, many organizations reflexively ‘shut down’ taking a ‘h ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in ead in the sand’ approach with the public. Others rapidly shift from one strategy to the next, shopping for something, anything that will resonate with the public. In fact, so lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. many high-profile gaffes have occurred, the public might be forgiven for wondering just who if anyone is in charge of the nation’s leading institutions and corporations. From here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe the failure of the former Director of FEMA to acknowledge the suffering evident to anyone with a television screen in flood ravaged Louisiana and Mississippi, to the unintellig d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ble or unbelievable statements of baseball legends called before Congressional committees investigating the use of steroids; the forehead slapping moments (‘What were they thin 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 king?’) continue to preoccupy us. So what can executives learn from such high-profile blunders? First and foremost, its that crises don't HAVE to leave reputations in ruin. I 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 ’s not the crisis as much as the way you react to it that deeply impacts your public reputation. That means the time to plan your crisis response is before your crisis occurs. nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically But how do you plan for the unexpected? There are a few key steps every organization can take to safeguard your hard-earned reputation in a crisis CREATE A CRISIS TEAM Thi 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 group of first responders has to be large enough to get the job done, but not so large as to be unwieldy. Include only essential decision makers. ASSIGN CLEAR TASKS AND LINES ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi OF COMMAND Make sure everyone knows the job they’ve been assigned during a crisis, who they’ll report directly to, and how often. Key positions include handling internal and ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a external communications with key stakeholders. Detailed record keeping by each member of the team is essential. Repeatedly ensure that contact information for each member of th dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod team is updated and that modes exist for two-way communication. APPOINT A SPOKESPERSON Limit the number of people speaking during a crisis, particularly to outside parties. cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin Make sure the spokesperson is a member of the crisis team and is kept well-informed on an on-going basis. ESTABLISH SYSTEMS OF COMMUNICATION TO THE PUBLIC AND TO THE MEDIA Te tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen porary websites, hotlines and direct media outreach are proven methods of keeping the media and the public informed during a crisis. Make sure you have a media kit at the ready 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 containing information about your company or organization, as well as a list of approved contacts. Make sure anyone answering phones understands to forward all inquiries to th ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust appropriate parties. DECIDE ON A RESPONSE Agree on and establish messages early and review them often as events unfold. Seek to tell what you know, when you know it. You sim y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products ply cannot wait until everything is known to issue your response. It's essential that people and safety issues are addressed first in every communication. Know that every stake . 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 older will want questions answered about what happened, why it happened, and what will happen next. DON’T LET OTHERS DELIVER BAD NEWS FOR YOU If there’s bad news, make sure y elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip our key stakeholders and the public hears it from you, not from regulators, the news media or others. Get the bad news out quickly and at once, rather than slowly and piecemeal 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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