Useful Advices - Business

Working in an intercultural environment is becoming increasingly common. One of the results of such set-ups is an experience of more communication difficulties. Different approaches to areas such management, c

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

ommunication, time, meetings, conflict resolution and the sharing of information are all culturally relative. When cultures come together and differ in their approaches, misunderstandings can and do occur. It

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

Examples of combination products may in

s these that can often lead to poor team performance or morale.

The intercultural team is by no means a straightforward environment. People need to be aware and sensitive to the dynamics of the group. However

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

consider the extra challenges when this team is virtual. By their very definition, virtual teams bring together people from different time zones, cultures, geographies and mind-sets making it highly unlikely

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

hat much team work will happen face-to-face, if at all. Consequently communication takes on a whole new dimension making it even more of a challenge.

In order to operate effectively any team needs trust. Buil

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

Combination pro

ing trust is critical. Yet in the virtual team this is very difficult to achieve. Without spending much time together can a team really gel? Some cultures such as the U.S. or Germany may find it easy, i.e. the

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

come from cultures where the relationship is not crucial. Other, more relationship driven cultures such as the Middle East or South America, may however struggle to ever feel totally at ease working with some

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

ne they do not know on a personal level.

Cultures have different ways of communicating; some are comfortable expressing opinions and discussing things openly and directly; others look for more subtle ways of

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

xpressing themselves. Some may have no issues raising delicate subjects in front of others; many cultures would not even contemplate doing so in an open arena. Some cultures use a lot of non-vernal communicati

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

n such body language and eye-contact to convey meaning; others rely almost completely on the spoken word. Some cultures are comfortable getting right down to business while others need a little time to make di

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

logue comfortable.

Working “blind”, i.e. not being in each others presence, increases the chances of misunderstandings. Throw in the cultural complexities and managing this is twice as problematic. Team mem

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

Following aspects would a

ers who are quieter (whether due to cultural or personal leanings) will make less of a contribution on telephone conference calls. Language proficiency will also play a significant role in the ability of peopl

dd to the challenges in developing combination products:

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

to contribute. Imagine how challenging it is for someone to join a spirited conversation on the telephone if they are either uncomfortable interrupting or not fluent in the language being used.

These are but

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

a few of the many intercultural complexities that make virtual teams very challenging.

For those working in an intercultural virtual team, the following ten tips are good guidelines to keep in mind to ensure

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

ommunication is kept clear:

1. If possible it is beneficial to bring all team members together physically. This can be at the birth of the team or at regular intervals.
2. The manager or team together s

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

ould establish clear ground rules of engagement covering issues such as:
a. How meetings are to be structured
b. How decisions will be made
c. How written communications will be used
d. Ho

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

Professional from academic institutions, pharmaceutical industries, health care indust

responses should be processed or given
e. How conflicts will be resolved
f. Whether interrupting a speaker will be acceptable
3. Written agendas for team meetings are important to give structur

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

.
4. Clear, easy-to-understand objectives that are communicated frequently must be created.
5. Carefully monitor how comfortable all team members are with the technology used in virtual meetings or c

.

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

mmunication. Support those that may be struggling.
6. Develop clear guidelines for email regarding formality and timeliness of response.
7. Solicit feedback from all participants.
8. Be careful

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

Companies that provide selfless information through particip

not to always interpret silence as agreement or incomprehension.
9. Follow-up meetings with written communication to be sure everyone understands.
10. Create an atmosphere that tolerates differences

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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