The Increasing PV Obligations of Scientific Literature

Scientific literature is a significant source of information for the monitoring of the safety profile of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues.

With global regulations constantly shifting and with the level of scientific literature progressively increasing, pharmacovigilance teams are under continued pressure to create literature strategies that are both comprehensive and flexible. Therefore, establishing the right process from the outset is fundamental to ensure that compliance deliverables are met.

5 points to consider when developing a literature review process:

1. Where to look for scientific literature?

The type of medicinal product (drug, medical device) should determine what type of database to use however, most well-known databases such as Medline or Embase cover most scientific and medical journals.

2. How to develop a scientific literature strategy?

Author abstracts are not always consistent in the choice of words relating to pharmacovigilance concepts thus, applying a search strategy will help to eliminate background noise, giving focus to scientific publications that are most relevant to pharmacovigilance. It is important to know your product and what you are trying to achieve; the highest recall for a search would be to enter the medicinal product name and active substance name (in all their variants) only. In practice, additional text can be added to increase precision. It is always good practice to retain a record of the search construction, the database used and the date the search was run.

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About the author
Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects. You can read more articles by Gemma by clicking the link below.
Other articles by Gemma Robinson PhD