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Advice You - Workplace Conflict - The Five W's for Intervention
"I deal with problems all the time. That's my job. But this one is messy. I don't know how to handle it and if we don't do something quick it's going to get ugly!"
Jocelyn (not her real name), VP of Human Re
Jocelyn (not her real name), VP of Human Re
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
sources in a mid-size manufacturing company, was worried about a situation in one of their plants. It wasn't the first time. She had been called into the plant several times over the past year. But this was b
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
gger.
One of the managers was in the process of removing two employees from their positions. Jocelyn had been working with the manager to make sure he followed proper procedure and had documentation to back
One of the managers was in the process of removing two employees from their positions. Jocelyn had been working with the manager to make sure he followed proper procedure and had documentation to back
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
p his claims. Then yesterday she received notice from a lawyer representing the two employees, making claims of verbal and physical abuse from that same manager. Today she'd received several unsolicited email
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
from other employees at the plant supporting those claims of abuse. A couple of the other plant managers had phoned her, letting her know there were problems brewing. And now the CEO had got wind of the "rum
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
lings" and was demanding that Jocelyn make the problems "go away."
Tempers were flaring, the situation was escalating, more individuals were getting involved, and the potential for a full-out crisis was immi
Tempers were flaring, the situation was escalating, more individuals were getting involved, and the potential for a full-out crisis was immi
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
ent. But Jocelyn wasn't sure what to do to calm things down and not add fuel to the fire.
Unfortunately, Jocelyn's indecision cost the company, in a number of ways. Tensions at the plant continued to intensi
Unfortunately, Jocelyn's indecision cost the company, in a number of ways. Tensions at the plant continued to intensi
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
fy, leading to shouting matches and even some physical confrontations. Everyone started taking sides. Employees talked about their lack of trust in management. Managers were busy assigning blame and denying i
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
volvement. The work environment was negative, accusatory, and secretive. Productivity took a serious downturn.
The ability to take quick, clear, decisive action in critical situations is a vital skill for an
The ability to take quick, clear, decisive action in critical situations is a vital skill for an
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
one in the company who, like Jocelyn, is responsible for dealing with issues and crises. Companies need to have a plan or framework for analyzing these situations and intervening in an effective and efficient
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
way. Knowing how to manage crisis is one of the most essential skills in the workplace today.
Is there a situation in your workplace that requires an intervention? Don't know where or how to start? Consider
Is there a situation in your workplace that requires an intervention? Don't know where or how to start? Consider
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
hese five questions:
Why? Issues arise all the time. They'll resolve themselves, won't they? Unfortunately, the answer is no. In fact, left unresolved, issues and conflicts seem to multiply. And, when
Why? Issues arise all the time. They'll resolve themselves, won't they? Unfortunately, the answer is no. In fact, left unresolved, issues and conflicts seem to multiply. And, when
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
conflicts appear, they take an enormous amount of employees' time and attention. Sometimes it's not the original issue itself, but the ripple effects that are so debilitating. When a problem arises that is af
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ecting people's ability to focus on their work, you've got to intervene.
When? Timing can be critical in an intervention. Hesitating can be seen as covering up, lack of leadership, even manipulation.
When? Timing can be critical in an intervention. Hesitating can be seen as covering up, lack of leadership, even manipulation.
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
If you don't want things to escalate further, the time to intervene is always now.
Where? As conflicts escalate, side issues can seem to spin out of control. But an intervention must get to the root c
Where? As conflicts escalate, side issues can seem to spin out of control. But an intervention must get to the root c
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
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
use of the situation and not just those side issues. For example, if an employee has been accused of offensive behavior, that individual must be dealt with specifically and immediately. Instituting a company-
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ide training program on respectful workplaces won't resolve the situation.
What? Interventions can take on many different forms and interveners may use different names for the work they do. Whether it
What? Interventions can take on many different forms and interveners may use different names for the work they do. Whether it
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
s called mediation, facilitation, dialogue, problem solving, or team building, make sure that the intervention directly relates to the root cause(s) of the problem, that it addresses all involved stakeholders
.
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
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
and that it results in workable long-term solutions.
Who? Interventions are most successful when they are led by a neutral third-party who has no vested interest in the outcome. And it is important t
Who? Interventions are most successful when they are led by a neutral third-party who has no vested interest in the outcome. And it is important t
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
at the intervener is seen as trustworthy, knowledgeable, and can develop a positive rapport with all parties.
Is there conflict in your workplace that is about to explode? Consider the five W's and intervene
Is there conflict in your workplace that is about to explode? Consider the five W's and intervene
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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