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Joint MHRA/DIA Excellence in Pharmacovigilance: Clinical Trials and Post-Marketing

The 5 days of training include a comprehensive overview of the core processes and systems in place and the latest news on the international harmonisation and standardisation activities in pharmacovigilance. Now available in individual Modules.


Agenda

Day 1

  • REGISTRATION
  • INTRODUCTION
  • KEYNOTE PRESENTATION
  • Basic Definitions and Tools in Pharmacovigilance
  • COFFEE BREAK
  • Basic Definitions and Tools in Pharmacovigilance continued
  • LUNCH
  • Classical Methods in Pharmacovigilance
  • COFFEE BREAK
  • Epidemiological Methods and Pharmacovigilance
  • NETWORKING RECEPTION

Day 2

  • SUSAR Reporting in Clinical Trials and Case Studies
  • COFFEE BREAK
  • SUSAR Reporting in Clinical Trials and Case Studies continued
  • LUNCH
  • The Role of the Qualified Person Responsible for Pharmacovigilance
  • Preparation of Development Safety Update Reports (DSURs)
  • COFFEE BREAK
  • Preparation of Periodic Safety Update Reports (PSURs)
  • Expedited Reporting Requirements in the Postauthorisation Phase and Case Studies
  • COFFEE BREAK
  • Expedited Reporting Requirements in the Postauthorisation Phase and Case Studies continued

Day 3

  • Expedited Reporting Requirements in the Postauthorisation Phase and Case Studies continued
  • COFFEE BREAK
  • Reporting Requirements in Special Situations in the Post-authorisation Phase and Case Studies
  • LUNCH
  • Pharmacovigilance System Master File (PSMF)
  • MedDRA and Standardised MedDRA Queries (SMQs)
  • COFFEE BREAK
  • Audits and Inspections in Pharmacovigilance - Regulatory Perspective
  • COFFEE BREAK
  • Audits and Inspections in Pharmacovigilance - Industry Perspective

Day 4

  • Medical Evaluation of Adverse Drug Reactions
  • Introduction to Signal Detection
  • Mobile Technologies and Social Media in Signal Management
  • COFFEE BREAK
  • Signal Management in the European Union: Industry Perspective
  • LUNCH
  • Signal Management – Workshop

Day 5

  • Risk Communication in EU – Challenges and Possibilities
  • COFFEE BREAK
  • An Overview of the Risk Management Process & the PRAC. The main components of the RMP
  • LUNCH
  • Risk Management Plans: An Industry Perspective
  • COFFEE BREAK
  • Effectiveness of Risk Minimisation Measures

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+41 61 225 51 51


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+41 61 225 51 55