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Advice You - How To Make An Inflexible Bureaucrat See You As A Person
Inflexible Bureaucrats Are Characterized by:
1. Cares little about your happiness in life
2. Sees people as numbers rather than faces
3. Pushed for time
4. Handles each person the same i.e. scripted procedure
1. Cares little about your happiness in life
2. Sees people as numbers rather than faces
3. Pushed for time
4. Handles each person the same i.e. scripted procedure
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
5. Hides behind policies and rules
6. Cannot look outside of the box
7. May have trouble remembering who you are due to a large volume of contacts
8. May not want to reveal anything about their interests
Descri
6. Cannot look outside of the box
7. May have trouble remembering who you are due to a large volume of contacts
8. May not want to reveal anything about their interests
Descri
; 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
ption
The bureaucrat is the grunt of an organization, originally meant for government institutions, but has been broadened to encompass any large organization or company. Bureaucrats include customer service representatives, insur
The bureaucrat is the grunt of an organization, originally meant for government institutions, but has been broadened to encompass any large organization or company. Bureaucrats include customer service representatives, insur
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ance claims filers, civil servants, social workers, airport employees etc. The bureaucrat typically views his clients as numbers rather than faces and is usually overworked and underpaid and underappreciated. Because of the large
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
volume of contacts that the bureaucrat handles on any given day, they often forget who they are dealing with and you become just another number.
How To Deal With The Bureaucrat
1. Be polite and respectful of their position. Too
How To Deal With The Bureaucrat
1. Be polite and respectful of their position. Too
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
often, the first things out of a customer’s mouth is some type of accusatory complain such as, “You people screwed up again.” While your anger might be justified, remember that the bureaucrat might not know who you are and will be
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
less inclined to help you if you are verbally abusive towards them.
2. Make sure that they have the authority to negotiate. Make sure you don’t waste your time dealing with someone who does not have the authority to negotiate wit
2. Make sure that they have the authority to negotiate. Make sure you don’t waste your time dealing with someone who does not have the authority to negotiate wit
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
h you. For example, if I was at a restaurant and wanted to order a dessert from the menu, then I would ask for a waiter or a waitress to help me rather than going to the chef or dishwasher. On the same note, make sure you don’t au
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
tomatically demand to speak to their superior because the subordinate will perceive that as a threat and react defensively against your favor. Also, their boss does not usually have the sufficient background information necessary t
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
o make a decision on your particular situation and many supervisors do not like overruling the decisions of their subordinates. They are more interested in the level of service that the subordinate provided you with because their e
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
xpertise is in management.
3. Make sure that they fully understand your situation. Explain your situation in detail and make sure that they understand the problem you are facing before moving on to solutions. The bureaucrat need
3. Make sure that they fully understand your situation. Explain your situation in detail and make sure that they understand the problem you are facing before moving on to solutions. The bureaucrat need
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
s to have a firm understanding of your problem in order for them to feel comfortable helping you with anything, so ask them rhetorical questions like, “Do you understand?” “Do you see where I’m coming from?” “Do you have any quest
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
ions?”
4. Acknowledge their expertise and ask for help. Treat the bureaucrat as an expert in their subject and ask them for advice. Bureaucrats constantly get verbally attacked everyday about being ignorant or not knowing enough
4. Acknowledge their expertise and ask for help. Treat the bureaucrat as an expert in their subject and ask them for advice. Bureaucrats constantly get verbally attacked everyday about being ignorant or not knowing enough
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
, so make yourself stand out and treat them like they had a PhD in their subject. This type of ego-stroking will persuade them to come up with options that you might not have thought of before.
5. Discuss the spirit versus the le
5. Discuss the spirit versus the le
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
tter of the law or policy. Often to prove their point, bureaucrats will open up a 900 page company bible or law book and quote to you section, chapter, paragraph, and line of the company policy on why they can’t help you. As with
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
any law or policy, there is some leeway for interpretation. There is the letter of the law—the specific words in that policy or law that dictate enforcement, and there is the spirit of the law—the specific intent of the authors who
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
wrote that law or policy. You might want to point out that the policy is good and purposeful, but it does not apply in your case because of your situation does not conform to the original spirit of that law or policy.
6. Determi
6. Determi
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ne a fair standard. Discuss with them what is a fair standard for your particular situation. If you are calling them because of a product defect, then what is the fair standard of getting that replaced or refunded? Agree on what
.
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
is an objective criteria to filter your options through.
7. Have your plan B ready. There is no formula for a 100% successful negotiation, but there is a formula for moving forward regardless of the outcome—and that is your plan
7. Have your plan B ready. There is no formula for a 100% successful negotiation, but there is a formula for moving forward regardless of the outcome—and that is your plan
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
B. Have your plan B fully developed and ready to go before dealing with a bureaucrat and you will not only have more confidence negotiating with them, but you will also be able to move forward regardless of the negotiating outcome.
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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