Presented by
Management Forum
Literature Searching in Drug Safety In-house Training
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.
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
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
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Gain a clear understanding of global and local literature searching regulatory requirements
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Learn how assessments help refine literature evaluation and reporting abilities
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Explore how to assess safety data to identify potential risks and compliance needs
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Develop critical analysis skills for interpreting safety data from literature
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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
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
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.
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:
