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| home > white papers > Biosimilars In Emerging Markets: Is It A Level Playing Field? - PRA Health Sciences (PRA) |
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 WHITE PAPERS |
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PRA Health Sciences (PRA)
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Biosimilars In Emerging Markets: Is It A Level Playing Field?
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Governments, healthcare payers, and social and health reforms, combined
with the increased incidence of conditions such as cancer and diabetes
are paving the way for increased uptake of biologic medicines in
emerging markets. However, expensive biologic medicines can be
prohibitive to many patients, creating a high level of unmet clinical
need. At its best, the global expansion of biosimilars can mean a robust
and steady supply of existing and new drugs reaching far-flung patient
populations, but localized biosimilar drug developments, especially in
China and India, combined with a lack of robust pharmacovigilance
systems, threaten to derail the industry by putting patient health at
risk.
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White Papers |
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Cleaning Validation: What do you need to consider to ensure a successful outcome?
RSSL
Cross contamination must be avoided in the Pharmaceutical industry at all costs and successful cleaning validation ensures that patients are not put at risk due to cross contamination.
The process can be divided into a number of sections each of which must be fully understood and areas of concern addressed to ensure a successful outcome across the entire process. This spans both the manufacturing and subsequent analytical and microbological support.
The data used to confirm a positive/successful cleaning validation is underpinned by the results of validated analytical methods. It is essential that these results are truly representative as patient safety is based upon the absence of equipment residues.
So what are those areas of concern, what affects your ability to get a successful outcome and what do you need to consider when carrying out a Cleaning Validation exercise?
More info >> |
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Industry Events |
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Pharma Packaging and Labelling East Coast 2019
20-21 February 2019, Phildaelphia, USA
Now
in its 11th year, Pharma Packaging and Labeling is back to deliver key,
actionable insights into very latest regulatory requirements, technological
innovations, strategic developments, and how to implement them into your
packaging and labeling chain with both maximum efficiency and minimal cost.
More info >> |
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