Assessment and Medical Evaluation of Individual Case Safety Reports
Venue: Novotel London West Hotel, Hammersmith, London
Date: 16 Oct – 17 Oct 2019*
Our Assessment and Medical Evaluation of Individual Case Safety Reports is an interactive course designed to provide delegates with the necessary skills and knowledge required to assess individual case safety reports. You will assess reports from various sources both from a regulatory and a clinical perspective. Evaluation of a cluster of reports or case series will be discussed, in addition to guidance regarding the coding of certain types of events such as off label use. The course covers the current and future requirements for the production of case narratives, at an individual level and also within regulatory submissions such as periodic benefit risk evaluation reports. Practical coaching takes place in small groups where delegates have the opportunity to discuss individual cases and receive feedback from expert tutors.
*Please note that the course dates and programme may be subject to change.
|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
Aims of 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
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
- 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
Cost Per Delegate:
£775 + VAT Academic
(Academic Units, Public Sector Organisations, Registered Charities)
£1190 + VAT Standard
Download Course Programme
Click here to download the programme
Great examples and practical sessions. The vigorous discussions were a highlight for me.
“Great course, great speakers and great content. Lots of good discussion during the presentations.”
“Very interactive and interesting course. Lots of practice questions which helped give more clarity of topics. All speakers were very engaging. Super course!”
“Good mix of people attending the course, was able to exchange knowledge and ideas.”
“Knowledgeable and approachable speakers. The practical sessions were very good and made easy to understand.”