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Just Other Articles - Managing Your Team (Part 1) - Is It Struggling?
I've lost count of the workshops in which Communication (internal or external) is the number one issue that groups and teams highlight.
The singular most effective way to deal with team problems is to talk about them.
BUT, how do we talk about them? What do we talk about?
It is not uncommon that teams struggle. It could be
The singular most effective way to deal with team problems is to talk about them.
BUT, how do we talk about them? What do we talk about?
It is not uncommon that teams struggle. It could be
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
...
Trying to start a new project
Trying to end a project
Trying to adapt to a new leader
Trying to adapt to a new member or members
Trying to deal with competing loyalties
Trying to implement new processes or procedures
If the team is newly formed and team members are still
If the team is newly formed and team members are still
; 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
at the stage of getting to know each other "as part of this unique team", I would like to suggest that article
Understanding Group Dynamics - Stages of Team Growth [2005-10-26], Article ID: 87167
should also be read to understand better the different (and sometimes difficult) stages that a new team will definitely go through.
Understanding Group Dynamics - Stages of Team Growth [2005-10-26], Article ID: 87167
should also be read to understand better the different (and sometimes difficult) stages that a new team will definitely go through.
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
>Suggested Causes Why The Team Is Struggling
Lack of Clear, Specific Objectives
The team or, at least, certain members may feel a little overwhelmed or uncertain as to their responsibilities, their key objectives and especially how they will be measured and held accountable. Moreover, there will be no real sense of Purpo
Lack of Clear, Specific Objectives
The team or, at least, certain members may feel a little overwhelmed or uncertain as to their responsibilities, their key objectives and especially how they will be measured and held accountable. Moreover, there will be no real sense of Purpo
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
se or Direction.
Left unmanaged, this can lead to wasted discussions and activities, no sense of working together, and objectives not being met.
Too Early
Teams can also struggle if the individual members are still unsure of their fellow team members. Some may feel that they still don't know others well enough to discuss is
Left unmanaged, this can lead to wasted discussions and activities, no sense of working together, and objectives not being met.
Too Early
Teams can also struggle if the individual members are still unsure of their fellow team members. Some may feel that they still don't know others well enough to discuss is
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ues or engage in real decision making. Some members may be reluctant to view their opinions, make suggestions especially if they are new to the team and are not (or feel they are not) encouraged to do so.
Lack of Consensus
Struggling to make decisions as a group may suggest a lack of consensus and, again, some members are re
Lack of Consensus
Struggling to make decisions as a group may suggest a lack of consensus and, again, some members are re
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
luctant, a little unsure to indicate that they don't agree and cannot support the team's decisions or conclusions.
Unable To Close
Different thoughts, feelings, fears may be at play here. At the end of a specific project, team members may be reluctant to 'officially' close the project. Maybe they are looking for something m
Unable To Close
Different thoughts, feelings, fears may be at play here. At the end of a specific project, team members may be reluctant to 'officially' close the project. Maybe they are looking for something m
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
ore, maybe the feel they are not ready to complete. This can result in decisions / conclusions being left open and the project being delayed.
This can also be the case when moving on from one phase to another. It may also be that team members are reluctant to move on because they feel unsure of what is required of them, there may a
This can also be the case when moving on from one phase to another. It may also be that team members are reluctant to move on because they feel unsure of what is required of them, there may a
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
lack of a clear plan or, again, objectives are not specific enough.
On a different slant, if the team has been together for some time, bonded well and achieved some significant results or improvements,closing can prove to be a tough time for the team members. In busy organizations, where mutiple deadlines have to be met, this trans
On a different slant, if the team has been together for some time, bonded well and achieved some significant results or improvements,closing can prove to be a tough time for the team members. In busy organizations, where mutiple deadlines have to be met, this trans
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
ition may be overlooked or not seen as all that important. Believe me, just as it takes individuals time to become a successful, cohesive unit, it also takes time for that team to separate. Please do not underestimate the importance of this. Sorry, no it doesn't fall into the 'Touchy Feely' category!!!
Fear of Failure
This
Fear of Failure
This
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
elates to either the inability to close the project off or even move from one phase to the next. It may be that presentations or reviews have to be made to senior management or groups outside the team and there is a reluctance to share the team's conclusions in case the results are not appreciated or are open to criticism, fair or un
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
fair.
All of these causes can be dealt with and, indeed, avoided. Much of this falls upon the shoulders of team leader but that is not to say that individual team members should not take their share of responsibility in making the team a successful one.
Team Problems and How We Should Talk About Them
Before highlighti
All of these causes can be dealt with and, indeed, avoided. Much of this falls upon the shoulders of team leader but that is not to say that individual team members should not take their share of responsibility in making the team a successful one.
Team Problems and How We Should Talk About Them
Before highlighti
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
ng some clues for dealing with the above causes, I would like to talk about Feedback. Giving and Receiving Feedback / Constructive Criticism is not easy and we shouldn't kid ourselves that it is.
The ONLY objective has to be successful problem resolution measured by the team making significant progress and moving forwa
The ONLY objective has to be successful problem resolution measured by the team making significant progress and moving forwa
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
rd as a cohesive unit.
If anyone uses 'feedback' as a means of delaying progress, revenge, upsetting people or any other less than positive motive, I suggest that the team would be more productive and a lot happier without that individual (no matter how successful that individual is).
Most of us understand the value of team buildin
If anyone uses 'feedback' as a means of delaying progress, revenge, upsetting people or any other less than positive motive, I suggest that the team would be more productive and a lot happier without that individual (no matter how successful that individual is).
Most of us understand the value of team buildin
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
g and interpersonal skills as well as technical skills especially in a leadership or team role. There are some excellent courses on Giving and Receiving Feedback and well worth the investment.
I will cover the basics in a later article.
Let's Not Struggle Any More
Although these clues are aimed at the team leader, again, in
I will cover the basics in a later article.
Let's Not Struggle Any More
Although these clues are aimed at the team leader, again, in
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
ividual team members have a key role to play in moving the team forward.
Objectives need to be clear, specific and measurable. If there is not true consensus, find out why and deal with it because without it, the team will definitely not achieve all it can achieve.
Part of reaching consensus is making sure everyone unde
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
rstands how these objectives relate to the overall Purpose and Direction of the team. What is the team's 'Mission'?
Being aware of and understanding any external influences and their relative importance helps the team to manage them. Remember, you may need the backing of these 'influences' at a later stage.
Identi
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
fy and articulate what is needed to move on if stuck. Do you need more information or data? Would additional support or assurances help? Identify and deal constructively with team member's feelings whether reasonable or unfounded.
With advance notice and 'Meetings Best Practice' facilitate a specific session with the obje
.
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
ctive of determining exactly how the team will move forward. Then make sure it does!
Make sure any review or presentation is the best it can be. All conclusions/recommendations are supported by hard data. Anticipate objections and determine how to deal with them. As team leader ALWAYS support your team players in an extern
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
al situation.
To help the group deal with the transition of separation at the end of a project, celebrate the team's success, communicate the team's success, publish their results. Be there for the team members after the team has separated, they were there for you!
The next article will look at Reluctant Team Members.
The next article will look at Reluctant Team Members.
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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