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Advice Pool - German Memories - Germans Against Roman Rule
In 7 A.D. a new governor became commander-in-chief over Germania: 55-year old Publius Varus who had married a niece of the Roman Emperor Augustus. He had 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
arlier served as governor in Syria, which led the first century Roman historian Velleius Paterculus to say, 'He came to the rich land poor and left a poor
; 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
and rich.'
He wanted to civilize the Germanic tribes by consistently introducing Roman laws. He tried to overcome with the sword those he couldn’t subdue
He wanted to civilize the Germanic tribes by consistently introducing Roman laws. He tried to overcome with the sword those he couldn’t subdue
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
y law. He came to central Germania and spent the summer time with jurisdiction and law-abiding proceedings before his bench among the people who were enjoy
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ng the sweetness of peace.
Yet the Germanic tribes had a different understanding of law than what Romans imposed on them. The tribes - used to liberty and
Yet the Germanic tribes had a different understanding of law than what Romans imposed on them. The tribes - used to liberty and
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
savageness - felt that the modern Roman state was enslaving and burdening them: In former times, dues had to be paid only by slaves.
Now with the Romans r
Now with the Romans r
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
quiring taxes from them, the Germanic tribes felt humiliated. What also filled them with bitterness was the fact that matters of dispute were decided by a
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
oman official - and not by an assembly of all free men. It was as if a slave master mediated disputes among his slaves.
In part, the dues were too high. T
In part, the dues were too high. T
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e Roman officials were accustomed to high revenues from other provinces. But for the Germanic tribes who were barely able to feed themselves, such tax dema
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
ds necessarily resulted in hardships.
Even the Germanic aristocrats were discontent. Over the last couple of years, they had ruled their tribes with Roman
Even the Germanic aristocrats were discontent. Over the last couple of years, they had ruled their tribes with Roman
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
assistance according to the Romans' wishes. Now they feared Varus' policy of a faster Romanization: If the Romans ruled Germania directly and extended thei
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
control to local matters, they would no longer need any indigenous stooges or collaborators. They feared that they would very soon lose their power, wealt
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
and privileges.
Apart from these general objections, most Germanic people were probably irked by the many small everyday humiliations, conflicts and quar
Apart from these general objections, most Germanic people were probably irked by the many small everyday humiliations, conflicts and quar
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
els. Roman officials objected to the insufficient size of the cattle skins delivered as tribute. But the race of cattle bred by the Germanic tribes was com
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
aratively small at that time. They knowingly ignored the fact and demanded additional payments. The corrupt officials were not indicted when they demanded
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
ribes, customs and taxes which appeared too high to the locals.
When soldiers of the occupying forces raped indigenous women, they were not punished or th
When soldiers of the occupying forces raped indigenous women, they were not punished or th
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
ir punishment was not severe enough by the Roman authorities.
All of these may have raised people's nostalgia for the 'good old time', when they were thei
All of these may have raised people's nostalgia for the 'good old time', when they were thei
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
own masters, when they could fight for themselves when faced with injustice, when they had to obey no one at all, and when their tribe's fate was still 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
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
ided by free voting of their own popular assembly - and not by the often unreasonable commands of subaltern Roman officials, who sometimes had arrived in G
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
rmania only a few weeks ago, who knew nothing about the previous customs of the people they governed and didn't care to know about the Germanic traditions
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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