2024-11-18 2024-11-18 , online online, 1,290 € zzgl. MwSt. Dr. Grit Lynch https://forum-institut.de/seminar/25032054-individual-case-safety-reports-icsrs/referenten/25/25_03/25032054-course-individual-case-safety-reports_lynch-grit.jpg Individual Case Safety Reports (ICSRs)

Reporting adverse drug reactions forms the foundation of drug safety. In this one-day online seminar, you will learn the regulatory requirements and best practices for ICSR reporting. Whether you are new to the topic or looking for a refresher, you will benefit from the extensive practical experience of our speakers from both Big Pharma and consulting!

Topics
  • GVP Module VI
  • Managing and reporting adverse events
  • Data management and quality assurance
  • Compliance requirements and audit readiness
  • Case studies: Best practices and common mistakes


Who should attend
This online course will be conducted in English.
This seminar is designed for employees of pharmaceutical companies involved in adverse event reporting or those who wish to enter this field. Additionally, service providers in pharmaceutical data processing are warmly invited to attend.
This online training is suitable both as an introduction and a refresher course.
Aims and objectives
This seminar aims to provide participants with comprehensive knowledge of Individual Case Safety Reporting (ICSRs) according to the guidelines of GVP Module VI. You can expect the following:
  • Compliance training within the framework of EU regulations
  • Good Pharmacovigilance Practices Module for adverse event reporting (GVP VI)
  • Global ICSR management
  • Hands-on explanations by two German experts
  • Interactive seminar with practical case reporting exercises
  • Up-to-date knowledge on automation possibilities and the use of AI
Your benefit

After the seminar, you will:

  • Be able to efficiently create and manage ICSRs
  • Understand the regulatory requirements for adverse event reporting and ensure compliance
  • Apply best practices in ICSR management
  • Identify and avoid potential sources of error

Online Course - Individual Case Safety Reports (ICSRs)

Individual Case Safety Reports (ICSRs)

Introduction and Refresher on GVP Module VI

Benefits
  • Established and new information
  • Best practices and automation possibilities
  • Interactive format with an included workshop
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25032054

Jetzt buchen

JETZT Buchen
Referenten

Dr. Grit Lynch

Biotest AG, Dreieich

Director CDS Operations, Corporate Drug Safety

Claudia Schaffer

Merck Healthcare KGaA, Darmstadt

Sr. Director, Head Case and Vendor Management Biopharma - Global Patient Safety - Operations

Alles auf einen Blick

Termin

10/03/2025

10/03/2025

Zeitraum

09:00-17:00 CET
You may dial in 30 min before the session

09:00-17:00 CET
You may dial in 30 min before the session
Veranstaltungsort

online

online

Downloads
Abbreviation list Pharmacovigilance/Drug Safety PROSPEKT
Abbreviation list Pharmacovigilance/Drug Safety PROSPEKT
Gebühr

Veranstaltung - 1,290 € zzgl. MwSt.
The fee includes high-quality course material for download, a participation certificate, access to the Learning Space as well as technical support including a test meeting.

Veranstaltung - 1,290 € zzgl. MwSt.
The fee includes high-quality course material for download, a participation certificate, access to the Learning Space as well as technical support including a test meeting.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Nadja Wolff
Conference Manager

+49 6221 500-696
n.wolff@forum-institut.de

Details

Reporting adverse drug reactions forms the foundation of drug safety. In this one-day online seminar, you will learn the regulatory requirements and best practices for ICSR reporting. Whether you are new to the topic or looking for a refresher, you will benefit from the extensive practical experience of our speakers from both Big Pharma and consulting!

Topics

  • GVP Module VI
  • Managing and reporting adverse events
  • Data management and quality assurance
  • Compliance requirements and audit readiness
  • Case studies: Best practices and common mistakes


Who should attend
This online course will be conducted in English.
This seminar is designed for employees of pharmaceutical companies involved in adverse event reporting or those who wish to enter this field. Additionally, service providers in pharmaceutical data processing are warmly invited to attend.
This online training is suitable both as an introduction and a refresher course.

Aims and objectives

This seminar aims to provide participants with comprehensive knowledge of Individual Case Safety Reporting (ICSRs) according to the guidelines of GVP Module VI. You can expect the following:

  • Compliance training within the framework of EU regulations
  • Good Pharmacovigilance Practices Module for adverse event reporting (GVP VI)
  • Global ICSR management
  • Hands-on explanations by two German experts
  • Interactive seminar with practical case reporting exercises
  • Up-to-date knowledge on automation possibilities and the use of AI

Your benefit

After the seminar, you will:

  • Be able to efficiently create and manage ICSRs
  • Understand the regulatory requirements for adverse event reporting and ensure compliance
  • Apply best practices in ICSR management
  • Identify and avoid potential sources of error

Detailed programme

09:00-17:00 CET
You may dial in 30 min before the session

Technical warm-up
You are welcome to log in a little earlier to test your audio and video equipment before the event begins.

Welcome and introduction

Dr Grit Lynch

Introduction to ICSR reporting
  • Laws, guidelines, and responsibilities
  • Reporting forms, templates, and tools
  • ICSR validation: 4 minimum criteria
  • E2B reporting formats and timelines
  • Documentation and archiving
  • Validated databases
  • Data protection and deletion

Coffee break


Dr Grit Lynch

Presentation & Workshop: How a case is reported
  • ICSR collection
  • Duplicate checks
  • Triage
  • Classification and special cases
  • Follow-up requests, reminders, and resubmissions
  • Medical case assessment
  • MedDRA coding
  • Reporting to and from the authorities

Lunch break


Claudia Schaffer

Quality assurance and compliance requirements
  • Standard Operating Procedures (SOPs)
  • Key Performance Indicators (KPIs)
  • Audit trail review: ICSR distribution, submission, and reconciliation
  • Corrective and preventive actions (CAPAs)
  • Common findings in audits and inspections

Claudia Schaffer

Automation in ICSR reporting
  • Automated data collection
  • Artificial Intelligence - opportunities and challenges
  • Development and use of bots
  • Discussion: New software and other digital tools

Coffee break


Claudia Schaffer, Dr Grit Lynch

Challenges for global companies
  • Key factors in collaboration for ICSR management: Headquarters, affiliates, distributors, and service providers
  • Differences in general PV requirements and their impact on ICSR management
  • Variability in reporting requirements and formats
  • Different reporting timelines and lines of communication
  • The challenge of "language requirements"

Dr Grit Lynch, Claudia Schaffer

Summary and discussion

End of Seminar


Ihr Nutzen

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

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