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  <titleInfo>
    <title>Pharmacovigilance medical writing : a good practice guide</title>
  </titleInfo>
  <name type="personal">
    <namePart>Orleans-Lindsay, Justina.</namePart>
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  <genre authority="">Electronic books.</genre>
  <originInfo>
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    <place>
      <placeTerm type="text">Chichester, West Sussex, UK</placeTerm>
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    <publisher>Wiley Blackwell</publisher>
    <dateIssued>2012</dateIssued>
    <issuance>monographic</issuance>
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  <tableOfContents>Pharmacovigilance medical writing : an overview across the drug development process -- Pharmacovigilance medical writing for clinical trials -- Pharmacovigilance medical writing for CTD submissions -- Pharmacovigilance medical writing in risk evaluation &amp; management -- Pharmacovigilance medical writing for marketed products -- The Ad-Hoc safety review &amp; response to questions document -- The rest of the world.</tableOfContents>
  <note type="statement of responsibility">Justina Orleans-Lindsay.</note>
  <note>Includes bibliographical references and index.</note>
  <subject authority="lcsh">
    <topic>Pharmacoepidemiology</topic>
  </subject>
  <subject authority="lcsh">
    <topic>Writing</topic>
  </subject>
  <subject authority="lcsh">
    <topic>Drug monitoring</topic>
  </subject>
  <subject authority="lcsh">
    <topic>Communication in medicine</topic>
    <topic>Methodology</topic>
  </subject>
  <subject authority="mesh">
    <topic>Pharmacoepidemiology</topic>
  </subject>
  <subject authority="mesh">
    <topic>Writing</topic>
  </subject>
  <subject authority="mesh">
    <topic>Drug Monitoring</topic>
  </subject>
  <subject authority="mesh">
    <topic>Health Communication</topic>
    <topic>methods</topic>
  </subject>
  <subject authority="mesh">
    <topic>Pharmaceutical Preparations</topic>
    <topic>adverse effects</topic>
  </subject>
  <subject authority="mesh">
    <topic>Product Surveillance, Postmarketing</topic>
  </subject>
  <subject authority="bisacsh">
    <topic>MEDICAL</topic>
    <topic>Pharmacy</topic>
  </subject>
  <classification authority="lcc">RM301.25</classification>
  <classification authority="ddc" edition="23">615/.4</classification>
  <classification authority="nlm">QZ 42</classification>
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      <publisher>Chichester, West Sussex, UK : John Wiley &amp; Sons Inc., 2012</publisher>
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  <identifier type="uri">http://onlinelibrary.wiley.com/book/10.1002/9781118301906</identifier>
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