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Signal Detection and Management in Pharmacovigilance
Signal Detection and Management in Pharmacovigilance

Course Description

Robust signal detection and management is the backbone of any pharmacovigilance system. Marketing authorisation holders are expected to continuously monitor all available data for safety signals and are required to have processes in place to evaluate such signals and take appropriate action. The ways by which companies may meet these expectations vary; what is suitable for one company may be hugely unrealistic or unnecessary for another. This course covers the regulatory expectations of signal detection and management and provides guidance for a structured, scientific approach to signal detection, validation, prioritisation and assessment. Through presentations, case studies, discussions and exercises, participants will obtain a critical understanding of the potential sources and methods for signal detection, ranging from single ICSRs and case series to data mining and AI-supported approaches. Methods for signal evaluation, including tools for assessment of causality and benefit-risk impact will be examined. Options and requirements for communication of confirmed signals and mitigation of new risks will be discussed. Finally, participants will learn about the interfaces of signal management with other PV system components such as PBRERs and RMPs, gain a quality system perspective of signal management, and explore how effective and compliant signal management can be implemented in their own organisation.

The course is in line with relevant regulatory guidelines such as EMA GVP, FDA Guidance for Industry, ICH and CIOMS.

  • Purpose and importance of signal management
  • Regulatory requirements, stakeholders, terminology and definitions
  • Overview of the signal management process: signal detection, validation, prioritisation and assessment; taking action
  • Signal detection: sources, methods, and pitfalls
  • Measures of disproportionality, data mining and
    signal detection in EVDAS
  • Signal validation and assessment: evaluation of
    data quality, causal relationship, frequency, and benefit-risk impact
  • Taking action: overview of requirements and options for further evaluation, communication and mitigation
  • Signal detection and management in clinical
    development
  • Interfaces of signal management with other PV
    processes: RMPs, PBRERs and PASS
  • Compliance, governance and quality assurance in
    signal management
  • RWD/RWE and AI in signal detection and management
  • Implementation of signal management in your
    organisation
  • Understand the regulatory requirements for signal management in major regions worldwide
  • Appreciate the strengths and limitations of different sources and methods for signal detection
  • Be able to query EVDAS and understand the outputs
  • Know how to validate and adequately prioritise signals for further assessment
  • Know how to systematically approach signal assessment to confirm or refute new potential associations and new aspects of known associations
  • Discuss requirements and options for communication of signals and management of associated risks
  • Understand the links between signal management and other PV system components such as PBRERs, RMPs and PASS
  • Realise the place of signal management within the pharmacovigilance system and understand expectations in regard to quality assurance in signal management
  • Understand how the signal management system and its outputs are documented, including in the PSMF
  • Have a critical understanding of the developing role of AI in signal detection and management
  • Design a system for signal detection and management in your organisation that is commensurate to your needs and compliant with regulatory expectations

Signal Detection and Management in Pharmacovigilance

New Dates TBA, Live Online Training
Regular price €1.850,00
Unit price
per 
Dr Mark Waring

Dr. Waring is a licensed physician, epidemiologist and senior pharmacovigilance expert with 25 years of full-time industry and consulting experience in clinical drug safety and post-marketing pharmacovigilance. His key areas of expertise include pharmacovigilance system and process consulting, safety data assessments and safety risk management planning.

START TIMES

9:00 AM Vienna time

8:00 AM London time

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Course Description

Robust signal detection and management is the backbone of any pharmacovigilance system. Marketing authorisation holders are expected to continuously monitor all available data for safety signals and are required to have processes in place to evaluate such signals and take appropriate action. The ways by which companies may meet these expectations vary; what is suitable for one company may be hugely unrealistic or unnecessary for another. This course covers the regulatory expectations of signal detection and management and provides guidance for a structured, scientific approach to signal detection, validation, prioritisation and assessment. Through presentations, case studies, discussions and exercises, participants will obtain a critical understanding of the potential sources and methods for signal detection, ranging from single ICSRs and case series to data mining and AI-supported approaches. Methods for signal evaluation, including tools for assessment of causality and benefit-risk impact will be examined. Options and requirements for communication of confirmed signals and mitigation of new risks will be discussed. Finally, participants will learn about the interfaces of signal management with other PV system components such as PBRERs and RMPs, gain a quality system perspective of signal management, and explore how effective and compliant signal management can be implemented in their own organisation.

The course is in line with relevant regulatory guidelines such as EMA GVP, FDA Guidance for Industry, ICH and CIOMS.

  • Purpose and importance of signal management
  • Regulatory requirements, stakeholders, terminology and definitions
  • Overview of the signal management process: signal detection, validation, prioritisation and assessment; taking action
  • Signal detection: sources, methods, and pitfalls
  • Measures of disproportionality, data mining and
    signal detection in EVDAS
  • Signal validation and assessment: evaluation of
    data quality, causal relationship, frequency, and benefit-risk impact
  • Taking action: overview of requirements and options for further evaluation, communication and mitigation
  • Signal detection and management in clinical
    development
  • Interfaces of signal management with other PV
    processes: RMPs, PBRERs and PASS
  • Compliance, governance and quality assurance in
    signal management
  • RWD/RWE and AI in signal detection and management
  • Implementation of signal management in your
    organisation
  • Understand the regulatory requirements for signal management in major regions worldwide
  • Appreciate the strengths and limitations of different sources and methods for signal detection
  • Be able to query EVDAS and understand the outputs
  • Know how to validate and adequately prioritise signals for further assessment
  • Know how to systematically approach signal assessment to confirm or refute new potential associations and new aspects of known associations
  • Discuss requirements and options for communication of signals and management of associated risks
  • Understand the links between signal management and other PV system components such as PBRERs, RMPs and PASS
  • Realise the place of signal management within the pharmacovigilance system and understand expectations in regard to quality assurance in signal management
  • Understand how the signal management system and its outputs are documented, including in the PSMF
  • Have a critical understanding of the developing role of AI in signal detection and management
  • Design a system for signal detection and management in your organisation that is commensurate to your needs and compliant with regulatory expectations

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Signal Detection and Management in Pharmacovigilance

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Medical-Devices-Certificate-Course

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