Assessment and Medical Evaluation of Individual Case Safety Reports2019-10-16T10:06:36+00:00

Project Description

Assessment and Medical Evaluation of Individual Case Safety Reports

Course overview

Venue: Novotel London West Hotel, Hammersmith, London

Date: 21 – 22 Oct 2020*

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 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

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
  • Small class size allows for one-to-one interaction with expert tutors
  • A combination of short lectures, practical workshops and interactive discussion sessions
  • Taught by a panel of expert speakers (minimum of four speakers per course) from industry, regulatory authorities and academia
  • Course materials including presentations, workshop material and suggested reading documents are made available electronically during the course
  • The agenda provides ample opportunity to network with expert speakers and your fellow delegates

Lunch, refreshments and all course materials are included in the registration fee.

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

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

Fees

Cost Per Delegate:

£775 + VAT Academic

(Academic Units, Public Sector Organisations, Registered Charities)

Or

£1190 + VAT Standard

(Standard Registration)

Registration fee includes lunch, refreshments and electronic access to all course materials.

Download Course Programme

Click here to download the programme

DOWNLOAD PROGRAMME

Booking options

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TESTIMONIALS

Great examples and practical sessions. The vigorous discussions were a highlight for me.

Case Reports Delegate 2018

“Great course, great speakers and great content. Lots of good discussion during the presentations.”

Case Reports Delegate 2017

“Very interactive and interesting course. Lots of practice questions which helped give more clarity of topics. All speakers were very engaging. Super course!”

Case Reports Delegate 2017

“Good mix of people attending the course, was able to exchange knowledge and ideas.”

Case Reports Delegate 2016

“Knowledgeable and approachable speakers. The practical sessions were very good and made easy to understand.”

Case Reports Delegate 2016

Individual Case Safety Reports Course Leader

Zeshan Iqbal – Associate Director in Pharmacovigilance Operations, Kinapse

  • Zeshan has an MSci in Medicinal Chemistry and a Ph.D in Bioelectrochemistry from University College London
  • After completing his Ph.D, Zeshan joined GlaxoSmithKline in their Pharmacovigilance Case Management Group in 2007 where he was involved in ensuring regulatory obligations for expedited reports were met as well as leading the safety data exchange agreement initiative
  • In 2010, Zeshan joined Johnson & Johnson in the Pharmacovigilance Aggregate Reports group where he was involved in producing post-marketing safety aggregate reports for assigned pharmaceutical and consumer products across a range of therapeutic areas
  • He was promoted to Manager in the Pharmacovigilance Evaluation and Reporting team responsible for performing continuous pharmacovigilance evaluation of products and he was also appointed the Lead for the Global Medical Organisation Innovation Team
  • Now Associate Director in Pharmacovigilance Operations at Kinapse, Zeshan has previously worked for over two years in the capacity of Program Lead and Program Director for large global outsourcing projects for clients

Contact Info

Drug Safety Research Unit Bursledon Hall, Blundell Lane, Southampton, SO31 1AA, U.K.

Phone: +44 (0)23 80 40 86 00

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