Guiding Principles for Medical Writers - PowerPoint PPT Presentation

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Guiding Principles for Medical Writers

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Medical writers are the professionals who write the content related to the medical field. Medical writers have detailed information about the area of medicine or pharmaceuticals that they are dealing with. – PowerPoint PPT presentation

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Title: Guiding Principles for Medical Writers


1
Guiding Principles for Medical Writers
2
Who are Medical Writers?
3
  • Medical writers are the professionals who write
    the content related to the medical field. Medical
    writers have detailed information about the area
    of medicine or pharmaceuticals that they are
    dealing with.
  • They are responsible for providing accurate,
    detailed and relevant information to the reader.
    They not only write fresh articles but also
    proofread and review the articles written by
    other medical writers. Medical writers deal with
    writing the following documents

4
  • General article Medical writers write general
    information related to therapeutic diseases,
    treatments, and the latest researches.
  • Research article Manuscript writing is another
    field for medical writers. The manuscript writers
    are experienced in writing the research article
    in a universal format that is globally accepted.
  • Regulatory documents Medical writers are also
    involved in writing regulatory documents. The
    regulatory documents are submitted for obtaining
    the approval of either drugs or medical devices
    from the concerned regulatory authority.

5
  • Continuing Medical Education The doctors
    generally present continuing Medical Education.
    For this, the writer prepares the presentation
    and writes the noted for the audience.
  • Company Newsletter Various companies have their
    own newsletters that incorporate the latest
    research or development. Medical writers write
    the newsletters.
  • Medical case-studies Doctors experience various
    unique cases during their medical practice. These
    cases are written to enhance the medical
    knowledge of medical fraternity.

6
What is Good Publication Practice Guideline?
7
  • Pharmaceutical companies act as sponsors in
    clinical trials. The reports of the clinical
    trials are submitted to the regulatory authority
    for obtaining approval. In various cases, the
    clinical trial reporting is not transparent and
    the data may lose its authenticity.
  • Good publication practice guidelines are the
    guidelines provided to the regulatory medical
    writers. These guidelines ensure that the
    clinical trial reporting is done in a responsible
    and ethical manner. Good publication practice
    guidelines were developed for the first time in
    2003 and from now they have been frequently
    revised. 

8
  • In 2015, a new version of Good publication
    practice guidelines was developed. This version
    was known as GPP3. GPP3 expands the basic values
    incorporated in GPP and GPP2. The evidence base
    information for medical writers was also
    explained in detail in the new version.
  • The steering committee is responsible for
    revising the GPP. The steering committee
    responsible for revising GPP 2 was diverse and
    includes representatives of medical writers, the
    pharmaceutical industry, biomedical devices,
    medical communication companies, and editors and
    publishers.

9
How Good Publication Practice Guideline 3 Helps
in Maintaining Standards for Medical Writers?
10
  • Prior to the good medical practice guidelines,
    there was a risk of inaccurate and incomplete
    information. International Committee of Medical
    Journal Editors states that medical writers are
    responsible for the publications done under their
    name.
  • Due to increased work and less time for writing
    by the Key opinion leaders, medical writers role
    becomes important. They provide data in simple
    and lucid language for publication and arrange
    the data from cross-functional teams.

11
What are the Salient Features of Good Publishing
Practice Guidelines?
12
  • Transparency There should be transparency in
    performing the research and writing the article.
  • Completeness The article should be complete and
    does not create confusion in the mind of the
    reader.
  • Accountability The guarantor can be assigned for
    the research article. The authors and presenters
    should be accountable for their work.
  • Responsibility The author or the medical writer
    should have respect for various intellectual
    property rights such as copyright.
  • Integrity There should be considerable integrity
    in article writing.

13
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