BEGIN:VCALENDAR
VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240328T164839Z
UID:174cfa25-175b-44ea-bb8a-90dee9ae9bfe
DTSTART:20210610T130000
DTEND:20210611T130000
CLASS:PRIVATE
DESCRIPTION:Overview
\nThe primary difference between
biopharmaceuticals and traditional pharmaceuticals is the method by which
the drugs are produced: Biopharmaceuticals are manufactured in living org
anisms such as bacteria\, yeast and mammalian cells\, whereas traditional
pharmaceuticals are manufactured through a series of chemical synthesis.\nBiopharmaceutical products make up an increasing share of new approv
als from the US Food and Drug Administration. Today\, biopharmaceuticals g
enerate global revenues of $163 billion\, making up about 20 percent of th
e pharma market. It&rsquo\;s by far the fastest-growing part of the indust
ry.
\nQuality functions are struggling to keep up with the rising dem
ands of regulators\, primarily the US Food and Drug Administration. The in
dustry has received an unprecedented number of warning letters and remedia
tion programs in the last five years\, and scrutiny is unlikely to decreas
e. Furthermore\, the increasing relevance of global markets (beyond the Un
ited States\, European Union\, and Japan) is adding the complexity of mult
iple quality standards and regulatory regimes.\n