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Advice You - The Responsibility Conundrum - Where art Thou?
Mr/Ms, ‘not me’ is often on holidays in your business. Yes come rain or shine they attend the workplace and put in the day for you; coffee to drink, gossip to catch up on, spying on management and colleagues, frequent toilet breaks, long lunches, long phone calls and let not forget the e 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 mail needs to be checked and replied. Off course the home business needs more customers so a few phone calls here and there are quite appropriate so they think! Meanwhile back at Mr/Ms Managers Office you are straining over the latest figures and wonder why productivity is waning, profit ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in are down and as you look out your office window you can see your workers seem happy. And can you believe it Absenteeism is down and why not your business has become a de-facto social club. Responsibility We appear to live in an age of irresponsibility! Taking responsibility is becomin lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. more of a rarity in business today as a generation of rights driven individuals care more about their ego’s than their character. Rights are important but rights come through taking responsibility I have found. The concept of an honest days work for an honest days pay; well it just isn’ here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe happening in some places anymore. As so as Mr/Ms Business Owner you trudge through your business day to day wondering what went wrong. Take responsibility! So what is Responsibility! In business responsibility could be defined as taking personal initiative to do what you are committ d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro d to, to keep your word, be honest, and act in the best interests of the business. Why the Change In a post modern era we have tried to remove the shackles of our youth for many reasons, and rightly so. This may have been because of past injustices, lack of opportunity, ignoring our ‘ro 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 ots’ and 'values' or maybe it could because we became lazy and could not be bothered anymore. A more worrying trend is that perhaps we have mistakenly removed responsibility and ethics when removing the other impediments. Teachers have told me that they are frightened of some of their s 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 udents and certainly the law does not allow reasonable discipline. Respect for the law is at an all time low. I recently heard that motorbike gangs have more members in New Zealand than the police force. What goes around comes around or what you reap is what you so is the old comments. nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically ut I hear you say we are living in a world of enlightenment! Consider this; higher numbers of rape, homicide, violence and crime in society and the workplace. Enlightenment appears to be a way off yet I suspect! Reclaiming you organisation You must take steps to reclaim your business i 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 it has become a kindergarten or a social club! You must take radical steps and involve yourself with your workers by getting out of your office and observing what goes on and making immediate changes. The Pain The old clich? is true; no pain no gain! In instances where we have been in ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi olved with organisations reclaiming their businesses we have observed the hurt and pain the owner has gone through to get their business back but we have seen them come out the other side and reap the rewards. Possible Solutions As a business owner you need to retake the authority you h ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a ave lost. You can start to do this by taking responsibility and • Spend more time working with your workers (initially) • Introducing responsibility by giving each worker a Job Description or changing and updating their old one with some KPI’s • Link the Job Description to a Performanc dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod , Productivity Bonus to strengthen the areas you want changed • Deal with recalcitrant employees firmly and swiftly • Send a silent message that irresponsibility and the holiday house is over; the key is silently • Cull the dead wood • Reward outstanding achievers • Build a team envi cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin onment where people are openly recognised and rewarded for their contributions • Take advice from seasoned experienced professionals • Keep at it and don’t become discouraged and lose heart You will win back your business and see your workers become responsible. Those who refuse to wil tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen move on or be moved on. The gain In assisting a business owner recently who had his employee’s totally running riot with productivity and profits down, this owner was looking at closing his business. After getting involved we negotiated an agreement with employees, unions and managemen 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 . An agreement was reached which included employees receiving a pay increase in return for the business receiving flexible working hours, Workable Rosters, Key Performance Indicators underpinning further pay increases, grievance and disciplinary measures and an agreement that employees wo ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust uld take personal responsibility for their own work down to workers looking after their colleagues call-out rosters when their colleagues were sick. This was a great outcome for the business owner and employees were happy. Some employees eventually left; they did not want the responsibil y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products ty and admitted this to the owner in private. Today the business has recorded record profits for the owner who could not be happier. What about You You can take control and have your business back under control. The question is do you want to endure some short lived pain for long term g . 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 in? I encourage you to get moving, get control and get advice. Take the time today to build your future, it’s worth it. Biz Momentum specialises in assisting businesses in their strategic human resource management and employee relations and has had the privilege to assist a number of co elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip cerned businesses.
Drop by and say hello at www.biz-momentum.com where there is more information to help your business grow. You are not alone; many have trod this path and reaped good rewards. Feel free to contact Philip at Biz Momentum with your story or question and take action today 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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