Assessment and Medical Evaluation of Individual Case Safety Reports (Hybrid Event)

Course Overview

Our Assessment and Medical Evaluation of Individual Case Safety Reports (ICSRs) is an interactive course designed to provide you with the necessary skills and knowledge required to assess ICSRs. You will review reports from various sources both from a regulatory and clinical perspective as well as understand medical review of Individual Case Safety Reports for causality and seriousness purposes. Evaluation of a cluster of reports or case series will be discussed, in addition to guidance regarding MedDRA coding of certain types of events and special situations such as off label use, as well as reports from literature and management of third parties.

The course covers the current and future requirements for the production of case narratives, at an individual level and within regulatory submissions such as periodic benefit risk evaluation reports. Importantly, the course provides a detailed view of the journey of an individual case safety report from receipt to submission. Practical coaching takes place in small groups where delegates have the opportunity to discuss individual scenarios and receive feedback from expert tutors from Regulators and Industry.

As well as being suitable for those new to ICSRs, the course will cover up-to-date information making it a good refresher for those with more experience.

Please note, the course dates and programme may be subject to change.
The in-person session of this course will only proceed when a minimum number of participants is met. Should this number not be reached, the registered participants will be notified at least three weeks prior to the course.

Our courses are recognised by PharmaTrain.

Who should attend

This course is aimed at:

• Pharmaceutical industry personnel from areas including pharmacovigilance, clinical research, medical affairs, medical writing, regulatory affairs and medical information
• Staff from regulatory authorities

As well as being suitable for those new to ICSRs, the course will cover up-to-date information making it a good refresher for those with more experience.

How our courses work

• Taught over two days
• A combination of lectures and interactive workshops
• Network with other delegates and speakers via scheduled discussion sessions (virtual delegates), and during coffee and lunch breaks (in-person delegates)
• Full access to PDFs of the presentations afterwards
• Use this course as part of your Continuing Professional Development (CPD)
• Refreshments and lunch provided (in-person delegates)
• Virtual delegates will be sent a link in advance to enable you to join the live course at the stated time

Aims of the course

• To enable delegates to acquire and practice the skills necessary for producing well written case narratives for reporting to regulatory authorities and for research reports
• To introduce delegates to the relevant regulatory requirements and the need to clear definitions and procedures for the reports of Adverse Drug Reactions

Learning outcomes

On successful completion of this course delegates should be able to:

• Relate the complexity of medical history taking into account challenges faced in producing good quality case narratives
• Define and appraise the critical data elements needed from reporting sources to complete a safety report
• Critically analyse an individual adverse event as to whether it is reportable and provide recommendations as to whether reporting should be expedited

Key topics

Programmed features:

• Assessment of reports from various sources both from a regulatory and a clinical perspective
• Evaluation of a cluster of reports/ case series
• Coding of atypical events
• Current and future requirements for the production of case narratives

Our fees

Please note, VAT is only applicable for delegates based in the UK.

Cost Per Delegate:

• Academic

  £620 + VAT

  (Academic Units, Public Sector Organisations, Registered Charities) - Virtual

• Academic

  £775 + VAT

  (Academic Units, Public Sector Organisations, Registered Charities - In-Person

• Standard

  £952 + VAT

  Virtual

• Standard

  £1190 + VAT

  In-Person

Registration fees include electronic access to all course materials. Lunch and refreshments are provided for those attending in-person.

Book now

• 18 October 2023 - 19 October 2023

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  UK Based International

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