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 lang=3DEN-GB style=3D'font-size:62%;color:yellow'>R.Ph, RAC, FTOPRA&#13;</=
span></div>
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 lang=3DEN-GB style=3D'font-size:65%;color:yellow'>Jarosz Regulatory Servic=
es, Inc
 (</span><span lang=3DEN-GB style=3D'font-size:65%;color:yellow'><p:onmouse=
click
  hyperlinktype=3D"url" href=3D"http://www.jrsweb.com/"/><a
 href=3D"http://www.jrsweb.com/" target=3D"_parent"
 onclick=3D"window.event.cancelBubble=3Dtrue;">www.jrsweb.com</a></span><sp=
an
 lang=3DEN-GB style=3D'font-size:65%;color:yellow'>) &#13;</span></div>
 <span style=3D'position:absolute;top:72.5%;left:33.52%;width:64.23%;height=
:3.0%'><span
 lang=3DEN-GB style=3D'font-size:50%;color:yellow'>AAPS Chicagoland Pharmac=
eutical
 Discussion Group (CPDG) </span></span><span style=3D'position:absolute;
 top:75.5%;left:33.52%;width:61.42%;height:3.0%'><span lang=3DEN-GB
 style=3D'font-size:50%;color:yellow'>symposium &#13;</span></span>
 <div style=3D'position:absolute;top:79.0%;left:33.52%;width:61.42%;height:=
3.0%'><span
 lang=3DEN-GB style=3D'font-size:50%;color:yellow'>April 11, 2008, Skokie, =
IL</span></div>
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r-index:
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</div>
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GB>To
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bsolute;
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n the
 EU and the US FDA CMC </span></span><span style=3D'position:absolute;top:4=
2.25%;
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span><span
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'><span
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><span
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'><span
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ay:none'>&#13;</span></span></div>
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 font-size:50%;color:white;mso-color-index:3;mso-special-format:lastCR;
 display:none'>&#13;</span></div>
 <![endif]><p:shaperange href=3D"master13.xml#_x0000_m421890"/><v:shape id=
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 <div v:shape=3D"_x0000_s522242" class=3DT style=3D'position:absolute;top:1=
2.25%;
 left:19.28%;width:74.9%;height:8.25%'>EU and FDA</div>
 <div v:shape=3D"_x0000_s522243">
 <div class=3DB style=3D'position:absolute;top:30.0%;left:19.28%;width:74.9=
%;
 height:6.0%'><span style=3D'position:absolute;top:0%;left:5.0%;width:95.0%;
 height:100.0%'><span class=3DBB style=3D'position:absolute;left:-5.26%;top=
:.16em'>o</span>EU
 &#8211; multiple agencies&#13;</span></div>
 <div class=3DB1><span style=3D'position:absolute;top:37.25%;left:27.52%;
 width:73.78%;height:5.5%'><span class=3DB1B style=3D'position:absolute;lef=
t:-4.31%;
 top:.39em'>n</span>European Medicines Evaluation Agency </span><span
 style=3D'position:absolute;top:42.75%;left:27.52%;width:68.91%;height:5.5%=
'>(EMEA)
 &#8211; administrative organization&#13;</span></div>
 <div class=3DB1><span style=3D'position:absolute;top:49.5%;left:27.52%;wid=
th:68.72%;
 height:5.5%'><span class=3DB1B style=3D'position:absolute;left:-4.63%;top:=
.39em'>n</span>Committee
 for Medicinal Products for </span><span style=3D'position:absolute;top:55.=
0%;
 left:27.52%;width:66.66%;height:5.5%'>Human Use (CHMP) of the EMEA &#8211;=
 </span><span
 style=3D'position:absolute;top:60.5%;left:27.52%;width:66.66%;height:5.5%'=
>scientific
 input&#13;</span></div>
 <div class=3DB1 style=3D'position:absolute;top:67.25%;left:24.34%;width:69=
.85%;
 height:5.5%'><span style=3D'position:absolute;top:0%;left:4.55%;width:95.4=
4%;
 height:100.0%'><span class=3DB1B style=3D'position:absolute;left:-4.77%;
 top:.39em'>n</span>National Health Agencies&#13;</span></div>
 <div class=3DB style=3D'position:absolute;top:74.0%;left:19.28%;width:74.9=
%;
 height:6.0%'><span style=3D'position:absolute;top:0%;left:5.0%;width:95.0%;
 height:100.0%'><span class=3DBB style=3D'position:absolute;left:-5.26%;top=
:.16em'>o</span>FDA
 &#8211; one agency</span></div>
 </div>
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52%;
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 mso-color-index:3;mso-field-code:meta15'>AAPS - CPDG Meeting April 11, 200=
8</span><span
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soku-overflow:
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r-index:
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2.25%;
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 <div v:shape=3D"_x0000_s523267">
 <div class=3DB style=3D'position:absolute;top:30.0%;left:19.28%;width:80.8=
9%;
 height:6.0%'><span style=3D'position:absolute;top:0%;left:4.62%;width:95.3=
7%;
 height:100.0%'><span class=3DBB style=3D'position:absolute;left:-4.85%;top=
:.16em'>o</span>EU
 &#8211; multiple registration procedures&#13;</span></div>
 <div class=3DB1 style=3D'position:absolute;top:37.25%;left:24.34%;width:69=
.85%;
 height:5.5%'><span style=3D'position:absolute;top:0%;left:4.55%;width:95.4=
4%;
 height:100.0%'><span class=3DB1B style=3D'position:absolute;left:-4.77%;
 top:.39em'>n</span>Centralized&#13;</span></div>
 <div class=3DB2 style=3D'position:absolute;top:43.75%;left:29.4%;width:64.=
79%;
 height:4.75%'><span style=3D'position:absolute;top:0%;left:3.75%;width:96.=
24%;
 height:100.0%'><span class=3DB2B style=3D'position:absolute;left:-3.9%;top=
:.39em'>p</span>European
 Community&#13;</span></div>
 <div class=3DB1 style=3D'position:absolute;top:49.75%;left:24.34%;width:69=
.85%;
 height:5.5%'><span style=3D'position:absolute;top:0%;left:4.55%;width:95.4=
4%;
 height:100.0%'><span class=3DB1B style=3D'position:absolute;left:-4.77%;
 top:.39em'>n</span>Decentralized/Mutual Recognition &#13;</span></div>
 <div class=3DB2 style=3D'position:absolute;top:56.25%;left:29.4%;width:64.=
79%;
 height:4.75%'><span style=3D'position:absolute;top:0%;left:3.75%;width:96.=
24%;
 height:100.0%'><span class=3DB2B style=3D'position:absolute;left:-3.9%;top=
:.39em'>p</span>At
 least 2 Member States&#13;</span></div>
 <div class=3DB1 style=3D'position:absolute;top:62.25%;left:24.34%;width:69=
.85%;
 height:5.5%'><span style=3D'position:absolute;top:0%;left:4.55%;width:95.4=
4%;
 height:100.0%'><span class=3DB1B style=3D'position:absolute;left:-4.77%;
 top:.39em'>n</span>National&#13;</span></div>
 <div class=3DB2 style=3D'position:absolute;top:68.75%;left:29.4%;width:64.=
79%;
 height:4.75%'><span style=3D'position:absolute;top:0%;left:3.75%;width:96.=
24%;
 height:100.0%'><span class=3DB2B style=3D'position:absolute;left:-3.9%;top=
:.39em'>p</span>1
 Member State&#13;</span></div>
 <div class=3DB style=3D'position:absolute;top:75.0%;left:19.28%;width:74.9=
%;
 height:6.0%'><span style=3D'position:absolute;top:0%;left:5.0%;width:95.0%;
 height:100.0%'><span class=3DBB style=3D'position:absolute;left:-5.26%;top=
:.16em'>o</span>FDA
 &#8211; one registration procedure</span></div>
 </div>
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52%;
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 mso-color-index:3;mso-field-code:meta15'>AAPS - CPDG Meeting April 11, 200=
8</span><span
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  href=3D"master13.xml#_x0000_m421891"/><v:shape id=3D"_x0000_s527363" type=
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2.25%;
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 <div v:shape=3D"_x0000_s527363">
 <div class=3DB style=3D'position:absolute;top:30.0%;left:19.28%;width:74.9=
%;
 height:6.0%'><span style=3D'position:absolute;top:0%;left:5.0%;width:95.0%;
 height:100.0%'><span class=3DBB style=3D'position:absolute;left:-5.26%;top=
:.16em'>o</span>CTD&#13;</span></div>
 <div class=3DB1 style=3D'position:absolute;top:37.25%;left:24.34%;width:69=
.85%;
 height:5.5%'><span style=3D'position:absolute;top:0%;left:4.55%;width:95.4=
4%;
 height:100.0%'><span class=3DB1B style=3D'position:absolute;left:-4.77%;
 top:.39em'>n</span>More similar than different&#13;</span></div>
 <div class=3DB><span style=3D'position:absolute;top:44.0%;left:23.03%;widt=
h:79.4%;
 height:6.0%'><span class=3DBB style=3D'position:absolute;left:-4.71%;top:.=
16em'>o</span>Bulk
 of the CMC data will be the same </span><span style=3D'position:absolute;
 top:50.24%;left:23.03%;width:71.16%;height:6.0%'>for both agencies</span><=
/div>
 </div>
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52%;
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8</span><span
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50%;
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 font-size:50%;color:white;mso-color-index:3;mso-special-format:lastCR;
 display:none'>&#13;</span></div>
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=3D"_x0000_s532482"
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  <o:lock v:ext=3D"edit" text=3D"f"/>
  <p:placeholder type=3D"title"/></v:shape><p:shaperange
  href=3D"master13.xml#_x0000_m421891"/><v:shape id=3D"_x0000_s532483" type=
=3D"#_x0000_m421891"
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  o:userdrawn=3D"f">
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2.25%;
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 <div v:shape=3D"_x0000_s532483">
 <div class=3DB><span style=3D'position:absolute;top:30.0%;left:23.03%;widt=
h:80.71%;
 height:6.0%'><span class=3DBB style=3D'position:absolute;left:-4.64%;top:.=
16em'>o</span>It
 is a harmonized format (template) for </span><span style=3D'position:absol=
ute;
 top:36.25%;left:23.03%;width:71.16%;height:6.0%'>presenting data in the ICH
 regions&#13;</span></div>
 <div class=3DB><span style=3D'position:absolute;top:43.5%;left:23.03%;widt=
h:77.15%;
 height:6.0%'><span class=3DBB style=3D'position:absolute;left:-4.85%;top:.=
16em'>o</span>It
 is <u>not</u> a list of data requirements for </span><span style=3D'positi=
on:
 absolute;top:49.75%;left:23.03%;width:71.16%;height:6.0%'>applications&#13=
;</span></div>
 <div class=3DB1 style=3D'position:absolute;top:56.75%;left:24.34%;width:69=
.85%;
 height:6.0%'><span style=3D'position:absolute;top:0%;left:4.55%;width:95.4=
4%;
 height:100.0%'><span class=3DB1B style=3D'position:absolute;left:-4.77%;
 top:.39em'>n</span>Result <span style=3D'font-family:Symbol;mso-char-type:=
symbol'>&THORN;</span>
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52%;
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 mso-color-index:3;mso-field-code:meta15'>AAPS - CPDG Meeting April 11, 200=
8</span><span
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50%;
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0000_s421905,_x0000_s421906,_x0000_s421907,_x0000_s421908,_x0000_s421909"
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43%;
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soku-overflow:
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 lang=3DEN-US style=3D'font-family:Arial;font-size:50%;color:white;mso-colo=
r-index:
 3;mso-field-code:meta0'>8/26/2008</span><span style=3D'font-family:Arial;
 font-size:50%;color:white;mso-color-index:3;mso-special-format:lastCR;
 display:none'>&#13;</span></div>
 <![endif]><p:shaperange href=3D"master13.xml#_x0000_m421890"/><v:shape id=
=3D"_x0000_s481282"
  type=3D"#_x0000_m421890" style=3D'position:absolute;left:132pt;top:36pt;w=
idth:552pt;
  height:102pt' o:userdrawn=3D"f">
  <v:fill o:detectmouseclick=3D"f"/>
  <v:stroke o:forcedash=3D"f"/>
  <o:lock v:ext=3D"edit" text=3D"f"/>
  <p:placeholder type=3D"title"/></v:shape><p:shaperange
  href=3D"master13.xml#_x0000_m421891"/><v:shape id=3D"_x0000_s481283" type=
=3D"#_x0000_m421891"
  style=3D'position:absolute;left:132pt;top:156pt;width:552pt;height:324pt'
  o:userdrawn=3D"f">
  <v:fill o:detectmouseclick=3D"f"/>
  <v:stroke o:forcedash=3D"f"/>
  <o:lock v:ext=3D"edit" text=3D"f"/>
  <p:placeholder type=3D"body" position=3D"1"/></v:shape>
 <div v:shape=3D"_x0000_s481282" class=3DT style=3D'position:absolute;top:1=
2.25%;
 left:19.28%;width:74.9%;height:8.25%'>CTD CMC Structure</div>
 <div v:shape=3D"_x0000_s481283">
 <div class=3DB style=3D'position:absolute;top:29.75%;left:19.28%;width:74.=
9%;
 height:5.25%'><span style=3D'position:absolute;top:0%;left:5.0%;width:95.0=
%;
 height:100.0%'><span style=3D'font-size:86%'><span class=3DBB style=3D'pos=
ition:
 absolute;left:-5.26%;top:.16em'>o</span></span><span style=3D'font-size:86=
%'>ICH
 M4Q Quality&#13;</span></span></div>
 <div class=3DB1 style=3D'position:absolute;top:36.0%;left:24.34%;width:69.=
85%;
 height:4.5%'><span style=3D'position:absolute;top:0%;left:4.55%;width:95.4=
4%;
 height:100.0%'><span style=3D'font-size:84%'><span class=3DB1B style=3D'po=
sition:
 absolute;left:-4.77%;top:.39em'>n</span></span><span style=3D'font-size:84=
%'>EU
 (CPMP/ICH/2887/99)&#13;</span></span></div>
 <div class=3DB1 style=3D'position:absolute;top:41.75%;left:24.34%;width:69=
.85%;
 height:4.5%'><span style=3D'position:absolute;top:0%;left:4.55%;width:95.4=
4%;
 height:100.0%'><span style=3D'font-size:84%'><span class=3DB1B style=3D'po=
sition:
 absolute;left:-4.77%;top:.39em'>n</span></span><span style=3D'font-size:84=
%'>FDA
 (M4 Q&amp;A guidance June 2004)&#13;</span></span></div>
 <div class=3DB style=3D'position:absolute;top:47.5%;left:19.28%;width:80.5=
2%;
 height:5.25%'><span style=3D'position:absolute;top:0%;left:4.65%;width:95.=
34%;
 height:100.0%'><span style=3D'font-size:86%'><span class=3DBB style=3D'pos=
ition:
 absolute;left:-4.87%;top:.16em'>o</span></span><span style=3D'font-size:86=
%'>2.3
 QOS<span style=3D'mso-tab-count:1;width:4.29%'> </span>Quality Overall Sum=
mary
 (QOS)&#13;</span></span></div>
 <div class=3DB style=3D'position:absolute;top:53.75%;left:19.28%;width:74.=
9%;
 height:5.25%'><span style=3D'position:absolute;top:0%;left:5.0%;width:95.0=
%;
 height:100.0%'><span style=3D'font-size:86%'><span class=3DBB style=3D'pos=
ition:
 absolute;left:-5.26%;top:.16em'>o</span></span><span style=3D'font-size:86=
%'>3.2.S<span
 style=3D'mso-tab-count:1;width:11.9%'> </span>Drug Substance (DS)&#13;</sp=
an></span></div>
 <div class=3DB style=3D'position:absolute;top:60.25%;left:19.28%;width:74.=
9%;
 height:5.25%'><span style=3D'position:absolute;top:0%;left:5.0%;width:95.0=
%;
 height:100.0%'><span style=3D'font-size:86%'><span class=3DBB style=3D'pos=
ition:
 absolute;left:-5.26%;top:.16em'>o</span></span><span style=3D'font-size:86=
%'>3.2.P<span
 style=3D'mso-tab-count:1;width:11.9%'> </span>Drug Product (DP)&#13;</span=
></span></div>
 <div class=3DB style=3D'position:absolute;top:66.5%;left:19.28%;width:74.9=
%;
 height:5.25%'><span style=3D'position:absolute;top:0%;left:5.0%;width:95.0=
%;
 height:100.0%'><span style=3D'font-size:86%'><span class=3DBB style=3D'pos=
ition:
 absolute;left:-5.26%;top:.16em'>o</span></span><span style=3D'font-size:86=
%'>3.2.A
 <span style=3D'mso-tab-count:1;width:10.61%'> </span>Appendices &#13;</spa=
n></span></div>
 <div class=3DB style=3D'position:absolute;top:73.0%;left:19.28%;width:74.9=
%;
 height:5.25%'><span style=3D'position:absolute;top:0%;left:5.0%;width:95.0=
%;
 height:100.0%'><span style=3D'font-size:86%'><span class=3DBB style=3D'pos=
ition:
 absolute;left:-5.26%;top:.16em'>o</span></span><span style=3D'font-size:86=
%'>3.2.R
 <span style=3D'mso-tab-count:1;width:10.34%'> </span>Regional&#13;</span><=
/span></div>
 <div class=3DB style=3D'position:absolute;top:79.5%;left:19.28%;width:74.9=
%;
 height:5.25%'><span style=3D'position:absolute;top:0%;left:5.0%;width:95.0=
%;
 height:100.0%'><span style=3D'font-size:86%'><span class=3DBB style=3D'pos=
ition:
 absolute;left:-5.26%;top:.16em'>o</span></span><span style=3D'font-size:86=
%'>3.3
 <span style=3D'mso-tab-count:2;width:15.02%'> </span>Literature References=
</span></span></div>
 </div>
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52%;
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 mso-color-index:3;mso-field-code:meta15'>AAPS - CPDG Meeting April 11, 200=
8</span><span
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r-index:
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2.25%;
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 <div class=3DB2 style=3D'mso-margin-left-alt:840'></div>
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 <div class=3DB style=3D'mso-margin-left-alt:336;position:absolute;top:30.0=
%;
 left:19.28%;width:74.9%;height:6.0%'><span style=3D'mso-special-format:nob=
ullet;
 display:none;color:#0078F0;mso-color-index:4;font-family:Wingdings;font-si=
ze:
 85%'>o</span>CTD can accommodate:&#13;</div>
 <div class=3DB style=3D'mso-margin-left-alt:336;position:absolute;top:37.5=
%;
 left:19.28%;width:74.9%;height:6.0%'><span style=3D'position:absolute;
 top:0%;left:7.75%;width:92.0%;height:100.0%'><span style=3D'mso-special-fo=
rmat:
 "numbullet3\,1";color:#0078F0;mso-color-index:4;position:absolute;left:-8.=
42%;
 top:.16em;font-size:85%'>1.</span>Differences in content&#13;</span></div>
 <div class=3DB style=3D'mso-margin-left-alt:336;position:absolute;top:44.7=
5%;
 left:19.28%;width:74.9%;height:6.0%'><span style=3D'position:absolute;
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rmat:
 "numbullet3\,1";color:#0078F0;mso-color-index:4;position:absolute;left:-8.=
42%;
 top:.16em;font-size:85%'>2.</span>Differences in review styles&#13;</span>=
</div>
 <div class=3DB style=3D'mso-margin-left-alt:336;position:absolute;top:52.2=
5%;
 left:19.28%;width:74.9%;height:6.0%'><span style=3D'position:absolute;
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rmat:
 "numbullet3\,1";color:#0078F0;mso-color-index:4;position:absolute;left:-8.=
42%;
 top:.16em;font-size:85%'>3.</span>Local particulars&#13;</span></div>
 <div class=3DB1 style=3D'mso-margin-left-alt:588;position:absolute;top:59.=
75%;
 left:24.34%;width:69.85%;height:5.5%'><span style=3D'position:absolute;
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rmat:
 bullet;color:#0078F0;mso-color-index:4;position:absolute;left:-8.11%;
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</span></div>
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25%;
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rmat:
 bullet;color:#0078F0;mso-color-index:4;position:absolute;left:-8.11%;
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ons</span></div>
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52%;
 height:2.75%'><span style=3D'font-family:Arial;font-size:50%;color:white;
 mso-color-index:3;mso-field-code:meta15'>AAPS - CPDG Meeting April 11, 200=
8</span><span
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2.25%;
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 <div v:shape=3D"_x0000_s484355">
 <div class=3DB style=3D'mso-line-spacing:"90 20 0";position:absolute;top:2=
9.5%;
 left:19.28%;width:85.39%;height:6.0%'><span style=3D'mso-special-format:no=
bullet;
 display:none;color:#0078F0;mso-color-index:4;font-family:Wingdings;font-si=
ze:
 85%'>o</span>ICH Q4A:<span style=3D'mso-spacerun:yes'>&nbsp;
 </span>Pharmacopeial Harmonization &#13;</div>
 <div class=3DB style=3D'mso-line-spacing:"90 20 0";position:absolute;top:3=
6.25%;
 left:19.28%;width:79.77%;height:6.0%'><span style=3D'position:absolute;
 top:0%;left:4.69%;width:95.3%;height:100.0%'><span style=3D'mso-special-fo=
rmat:
 bullet;color:#0078F0;mso-color-index:4;position:absolute;left:-4.92%;
 top:.16em;font-family:Wingdings;font-size:85%'>o</span>Harmonize compendial
 test chapters&#13;</span></div>
 <div class=3DB1 style=3D'mso-line-spacing:"90 20 0";position:absolute;top:=
43.0%;
 left:24.34%;width:71.16%;height:5.5%'><span style=3D'position:absolute;
 top:0%;left:4.47%;width:95.52%;height:100.0%'><span style=3D'mso-special-f=
ormat:
 bullet;color:#0078F0;mso-color-index:4;position:absolute;left:-4.68%;
 top:.39em;font-family:Wingdings;font-size:70%'>n</span>Interchangeable in =
the
 3 ICH regions &#13;</span></div>
 <div class=3DB style=3D'mso-line-spacing:"90 20 0"'><span style=3D'positio=
n:absolute;
 top:49.25%;left:23.03%;width:84.08%;height:6.0%'><span style=3D'mso-specia=
l-format:
 bullet;color:#0078F0;mso-color-index:4;position:absolute;left:-4.45%;
 top:.16em;font-family:Wingdings;font-size:85%'>o</span>Pharmacopeial
 Discussion Group (PDG) </span><span style=3D'position:absolute;top:54.5%;
 left:23.03%;width:71.16%;height:6.5%'><span style=3D'font-family:Symbol;
 mso-char-type:symbol'>&THORN;</span> USP, JP, EP (PhEur) &#13;</span></div>
 <div class=3DB style=3D'mso-line-spacing:"90 20 0";position:absolute;top:6=
1.75%;
 left:19.28%;width:82.58%;height:6.0%'><span style=3D'position:absolute;
 top:0%;left:4.53%;width:95.46%;height:100.0%'><span style=3D'mso-special-f=
ormat:
 bullet;color:#0078F0;mso-color-index:4;position:absolute;left:-4.75%;
 top:.16em;font-family:Wingdings;font-size:85%'>o</span>11 General Test
 Chapters in ICH Q6A&#13;</span></div>
 <div class=3DB style=3D'mso-line-spacing:"90 20 0"'><span style=3D'positio=
n:absolute;
 top:68.5%;left:23.03%;width:71.16%;height:6.0%'><span style=3D'mso-special=
-format:
 bullet;color:#0078F0;mso-color-index:4;position:absolute;left:-5.26%;
 top:.16em;font-family:Wingdings;font-size:85%'>o</span>PDG submits
 pharmacopeial text </span><span style=3D'position:absolute;top:74.0%;left:=
23.03%;
 width:78.83%;height:6.0%'>proposals to ICH Q4B Expert Working </span><span
 style=3D'position:absolute;top:79.75%;left:23.03%;width:71.16%;height:6.0%=
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 (EWG)</span></div>
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52%;
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2.25%;
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 <div style=3D'position:absolute;top:30.0%;left:19.28%;width:85.58%;height:=
6.0%'><span
 style=3D'mso-special-format:nobullet;display:none;color:#0078F0;mso-color-=
index:
 4;font-family:Wingdings;font-size:85%'>o</span>ICH Q4B: Evaluation &amp;
 Recommendation&#13;</div>
 <span style=3D'position:absolute;top:37.5%;left:23.03%;width:81.83%;height=
:6.0%'><span
 class=3DBB style=3D'position:absolute;left:-4.57%;top:.16em'>o</span>Expert
 Working Group (ICH Q4B EWG) </span><span style=3D'position:absolute;top:43=
.5%;
 left:23.03%;width:82.58%;height:6.0%'>evaluates pharmacopeial text proposa=
ls </span><span
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'>from
 PDG and assesses regulatory </span><span style=3D'position:absolute;top:56=
.0%;
 left:23.03%;width:71.16%;height:6.0%'>impact&#13;</span>
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pan
 class=3DBB style=3D'position:absolute;left:-4.6%;top:.16em'>o</span>Dialog=
ue
 between PDG and Q4B EWG&#13;</span></div>
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:6.0%'><span
 class=3DBB style=3D'position:absolute;left:-5.2%;top:.16em'>o</span>Q4B EW=
G makes
 conclusions and </span><span style=3D'position:absolute;top:77.25%;left:23=
.03%;
 width:76.02%;height:6.0%'>recommendations in the ICH regions</span></div>
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52%;
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0000_s495664,_x0000_s495663,_x0000_s495662,_x0000_s495661,_x0000_s495652,_x=
0000_s495651,_x0000_s495650,_x0000_s495649,_x0000_s495648,_x0000_s495647,_x=
0000_s495646,_x0000_s495645,_x0000_s495644,_x0000_s495643,_x0000_s495642,_x=
0000_s495641,_x0000_s495640,_x0000_s495639,_x0000_s495638,_x0000_s495637,_x=
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2.25%;
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 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
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 top:81.0%;left:69.28%;width:11.42%;height:3.25%'><span style=3D'font-size:=
58%'>No</span></div>
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:absolute;
 top:81.0%;left:53.55%;width:14.04%;height:3.25%'><span style=3D'font-size:=
58%'>No</span></div>
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 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'mso-margin-left-alt:0;position:absolute;top:81.0=
%;
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span></div>
 </div>
 <div v:shape=3D"_x0000_s495668">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolute;
 top:76.0%;left:82.58%;width:11.42%;height:3.25%'><span style=3D'font-size:=
58%'><b>Yes</b></span></div>
 </div>
 <div v:shape=3D"_x0000_s495667">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolute;
 top:76.0%;left:69.28%;width:11.42%;height:3.25%'><span style=3D'font-size:=
58%'><b>Yes</b></span></div>
 </div>
 <div v:shape=3D"_x0000_s495666">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolute;
 top:76.0%;left:53.55%;width:14.04%;height:3.25%'><span style=3D'font-size:=
58%'><b>Yes</b></span></div>
 </div>
 <div v:shape=3D"_x0000_s495665">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'mso-margin-left-alt:0;position:absolute;top:76.0=
%;
 left:7.67%;width:44.0%;height:3.25%'><span style=3D'font-size:58%'>Residue=
 on
 Ignition/Sulphated ash(rev. 2)</span></div>
 </div>
 <div v:shape=3D"_x0000_s495664">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolute;
 top:71.0%;left:82.58%;width:11.42%;height:3.25%'><span style=3D'font-size:=
58%'><b>Yes</b></span></div>
 </div>
 <div v:shape=3D"_x0000_s495663">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolute;
 top:71.0%;left:69.28%;width:11.42%;height:3.25%'><span style=3D'font-size:=
58%'><b>Yes</b></span></div>
 </div>
 <div v:shape=3D"_x0000_s495662">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolute;
 top:71.0%;left:53.55%;width:14.04%;height:3.25%'><span style=3D'font-size:=
58%'><b>Yes</b></span></div>
 </div>
 <div v:shape=3D"_x0000_s495661">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'mso-margin-left-alt:0;position:absolute;top:71.0=
%;
 left:7.67%;width:44.0%;height:3.25%'><span style=3D'font-size:58%'>Bacteri=
al
 Endotoxins</span></div>
 </div>
 <div v:shape=3D"_x0000_s495652">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolute;
 top:63.5%;left:82.58%;width:11.42%;height:3.25%'><span style=3D'font-size:=
58%'><b>Yes</b></span></div>
 </div>
 <div v:shape=3D"_x0000_s495651">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolute;
 top:63.5%;left:69.28%;width:11.42%;height:3.25%'><span style=3D'font-size:=
58%'><b>Yes</b></span></div>
 </div>
 <div v:shape=3D"_x0000_s495650">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolute;
 top:63.5%;left:53.55%;width:14.04%;height:3.25%'><span style=3D'font-size:=
58%'><b>Yes</b></span></div>
 </div>
 <div v:shape=3D"_x0000_s495649">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'mso-margin-left-alt:0'><span style=3D'position:a=
bsolute;
 top:63.5%;left:7.67%;width:51.68%;height:3.25%'><span style=3D'font-size:5=
8%'>Microbiological
 Quality (specific microorganisms + </span></span><span style=3D'position:a=
bsolute;
 top:66.75%;left:7.67%;width:45.88%;height:3.25%'><span style=3D'font-size:=
58%'>enumeration
 + contamination for non-sterile)</span></span></div>
 </div>
 <div v:shape=3D"_x0000_s495648">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolute;
 top:58.5%;left:82.58%;width:11.42%;height:3.25%'><span style=3D'font-size:=
58%'>No</span></div>
 </div>
 <div v:shape=3D"_x0000_s495647">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolute;
 top:58.5%;left:69.28%;width:11.42%;height:3.25%'><span style=3D'font-size:=
58%'><b>Yes</b></span></div>
 </div>
 <div v:shape=3D"_x0000_s495646">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolute;
 top:58.5%;left:53.55%;width:14.04%;height:3.25%'><span style=3D'font-size:=
58%'><b>Yes</b></span></div>
 </div>
 <div v:shape=3D"_x0000_s495645">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'mso-margin-left-alt:0;position:absolute;top:58.5=
%;
 left:7.67%;width:44.0%;height:3.25%'><span style=3D'font-size:58%'>Sterili=
ty
 (rev. 1)</span></div>
 </div>
 <div v:shape=3D"_x0000_s495644">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolute;
 top:53.75%;left:82.58%;width:11.42%;height:3.25%'><span style=3D'font-size=
:58%'>No</span></div>
 </div>
 <div v:shape=3D"_x0000_s495643">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolute;
 top:53.75%;left:69.28%;width:11.42%;height:3.25%'><span style=3D'font-size=
:58%'><b>Yes</b></span></div>
 </div>
 <div v:shape=3D"_x0000_s495642">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolute;
 top:53.75%;left:53.55%;width:14.04%;height:3.25%'><span style=3D'font-size=
:58%'>No</span></div>
 </div>
 <div v:shape=3D"_x0000_s495641">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'mso-margin-left-alt:0;position:absolute;top:53.7=
5%;
 left:7.67%;width:44.0%;height:3.25%'><span style=3D'font-size:58%'>Particu=
late
 Matter (rev. 1)</span></div>
 </div>
 <div v:shape=3D"_x0000_s495640">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolute;
 top:48.75%;left:82.58%;width:11.42%;height:3.25%'><span style=3D'font-size=
:58%'><b>Yes</b></span></div>
 </div>
 <div v:shape=3D"_x0000_s495639">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolute;
 top:48.75%;left:69.28%;width:11.42%;height:3.25%'><span style=3D'font-size=
:58%'><b>Yes</b></span></div>
 </div>
 <div v:shape=3D"_x0000_s495638">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolute;
 top:48.75%;left:53.55%;width:14.04%;height:3.25%'><span style=3D'font-size=
:58%'>No</span></div>
 </div>
 <div v:shape=3D"_x0000_s495637">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'mso-margin-left-alt:0;position:absolute;top:48.7=
5%;
 left:7.67%;width:44.0%;height:3.25%'><span style=3D'font-size:58%'>Extract=
able
 Volume of Parenterals (rev. 1)</span></div>
 </div>
 <div v:shape=3D"_x0000_s495636">
 <div class=3DTbl1 style=3D'mso-margin-left-alt:288'></div>
 <div class=3DTbl2 style=3D'mso-margin-left-alt:576'></div>
 <div class=3DTbl3 style=3D'mso-margin-left-alt:864'></div>
 <div class=3DTbl4 style=3D'mso-margin-left-alt:1152'></div>
 <div class=3DTbl style=3D'text-align:center;mso-margin-left-alt:0;position=
:absolu
