Assessment and Medical Evaluation of Individual Case Safety Reports2018-10-24T16:51:21+00:00

Project Description

Assessment and Medical Evaluation of Individual Case Safety Reports

Course overview

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

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)

Download Course Programme

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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

Course Leader

Maria Diedrick – PV Process Development Leader

Maria joined the Scientific Enablement and Processes Team at Roche as a Process Development Leader for case handling in 2015.

Maria has over 18 years’ experience in pharmacovigilance and strong expertise in case handling process ownership, the ongoing delivery of key areas of business outsourcing and regulatory inspections.

A native of Venezuela, Maria moved to the UK after completing her Law degree and started her career in Drug Safety at AstraZeneca.  Maria also completed a post-graduate Certificate in Pharmacovigilance from Hertfordshire University in 2009.

Maria started her career in the AstraZeneca case handling operations team.  She also worked as Patient Safety Scientist in the Surveillance teams where she supported the Safety Management Teams, contributed to health authority responses, risk management plans and submission preparation activities.

In her latest position as the Global Process Owner for case handling and Safety Outsourcing Lead at AstraZeneca, Maria was responsible for the design, maintenance/improvement of global processes and the primary interface lead for various compliance-critical safety processes outsourced to external vendors. As a member of the Patient Safety Governance team, Maria lead and participated in overall process governance and stakeholder management activities, by providing subject matter expertise to influence and implement governance decisions.  Maria also represented the company at many pharmacovigilance regulatory inspections around the world.

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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