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Management Forum

Literature Searching in Drug Safety Training Course

This two-day course offers a thorough understanding of literature searching in drug safety, covering regulatory requirements, search criteria, and the interpretation of safety data, while also providing practical assessments to apply knowledge to real-world pharmacovigilance cases.

11-12 September 2025
+ 12-13 January 2026, 19-20 May 2026 »

from £1299

Need help?  Enrol/reserve

Course overview

This comprehensive two-day course provides an in-depth understanding of literature searching in drug safety, focusing on regulatory requirements, literature search criteria, and the interpretation of safety data from published sources. Participants will explore best practices for conducting literature searches, identifying relevant safety information, and prioritising articles for review. Practical assessments will enable attendees to apply their knowledge to real-world case studies, ensuring they are equipped with the necessary skills to effectively manage literature searches in pharmacovigilance.

This course is part of our Vigilance training course collection; for information on the basics of PhV, consider taking a look at our beginner-friendly Pharmacovigilance training course.

Benefits of attending

  • Gain a clear understanding of global and local literature searching regulatory requirements

  • Learn how assessments help refine literature evaluation and reporting abilities

  • Explore how to assess safety data to identify potential risks and compliance needs

  • Develop critical analysis skills for interpreting safety data from literature

  • Discover how to effectively manage literature searches within pharmacovigilance processes

Who should attend?

Professionals working within these industries, who want a comprehensive introduction, will benefit from this engaging course:

  • Clinical
  • Pharmacovigilance
  • Regulatory

Enrol/reserve

This course will cover:

The regulations concerning literature searchin

  • What needs to be searched
  • Individual safety data and ‘group’ data
  • The literature search engine requirements – regulatory expectations
  • Local literature searching versus global – regulatory expectations

The literature search criteria

  • Regulatory expectations
  • Setting up the literature search
  • Excipients and literature searching
  • Literature search ‘hits’ and reviews

What literature articles need to be reviewed

  • Individual Case Safety Reports (ICSRs)
  • Medical literature monitoring (MLMs)
  • Meta-analyses
  • Class effect reports
  • Clinical studies
  • Pharmacoepidemiological studies
  • Foreign reports in the literature involving the active ingredient

Prioritisation of literature articles

  • ICSRs including abstracts
  • Study reports – clinical studies
  • Pharmacoepidemiological studies
  • Off-label studies

Literature article reviews

  • Literature articles and ICSRs
  • Literature articles and Periodic Benefit-Risk Evaluation Report (PBRERs)
  • Literature articles in signal detection
  • Literature articles and ‘special situations’

Practical assessment of literature article and ICSRs

  • What needs to happen with a literature article report that contains an ICSR
  • What needs to happen with the article, timelines and reporting

Practical assessment of a pre-clinical finding in the literature

  • Review a literature article containing information from a pre-clinical study in the literature that contains safety information that is not included in the SPC/Product Monograph and what to do next
  • Delegates will be asked what needs to be done with such an article

Practical assessment of a clinical study

  • Delegates will be given a clinical study from the literature conducted by academics for an off-label indication for the company product
  • Delegates will be asked what needs to happen with such a report

Practical assessment of a study involving the company

  • Delegates will look at a study involving the company product and asked whether and what should be looked at in the study and where such information should be discussed and reported

Practical assessment of a pharmacoepidemiological study

  • Delegates will be provided with a pharmacoepidemiological study involving the company product
  • They will be asked to interpret the information, including what needs to happen next and what if any influence this would have on current labelling or signalling

Enrol/reserve

Graeme Ladds
PharSafer Associates Ltd

Graeme is Director of PharSafer and has over 30 years’ experience working in the pharmaceutical industry, having started his career at Ashbourne Pharmaceuticals as Head of Drug Safety and Medical Information. Graham has a wealth of experience establishing pharmacovigilance within companies.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

11-12 September 2025

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 15681

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,087 2,399

Until 07 Aug

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Not ready to book yet?

for 7 days, no obligation

12-13 January 2026

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 15682

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,087 2,399

Until 08 Dec

View basket 

 
Not ready to book yet?

for 7 days, no obligation

19-20 May 2026

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 15683

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,087 2,399

Until 14 Apr

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Run Literature Searching in Drug Safety Live online for your team

Pricing from:

  • GBP 1,000
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipiacademy.com