Drug Safety Literature Searching Training Course | Explore Best Practices and Enhance Reporting Abilities (ONLINE EVENT: September 11-12, 2025) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Literature Searching in Drug Safety Training Course" training has been added to ResearchAndMarkets.com's offering.

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.

Benefits of attending

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

Certifications:

• CPD: 12 hours for your records
• Certificate of completion

Who Should Attend:

• Clinical
• Pharmacovigilance
• Regulatory

Key Topics Covered:

Day 1

The regulations concerning literature searching

• 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'

Day 2

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

Speakers:

Graeme Ladds

Director

PharSafer Associates Ltd.

Graeme Ladds, Director of PharSafer, has over 30 years' experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.

For more information about this training visit https://www.researchandmarkets.com/r/3rwqw2

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