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Impact of the European Pharmacovigilance Legislation on International Companies

by Steve Jolley

Languages: English

Price (from): €6,000 / day

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About the trainer:

•    Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection and is a frequent speaker at leading industry events with FDA, EMA, and MHRA on the topics of auditing and signaling
•    Steve has 30 years’ experience in drug safety & pharmacovigilance and has worked with over 200 clients worldwide. He holds degrees in mathematics and computer science from Cambridge University, England. 
•    He is an Adjunct Professor at Rutgers University and teaches part of their Master's degree in Drug Safety and Pharmacovigilance. 
•    Steve has conducted over 200 audits for pharmaceutical companies in the US, EU, India, and Japan in order to prepare for both FDA and EU pharmacovigilance inspections.
•    Steve was elected chairperson of the DIA Clinical Safety and Pharmacovigilance steering committee for North America.  He is a member of DIA’s training faculty and instructs as part of DIA’s Clinical Safety and Pharmacovigilance Certificate Program.


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Impact of the European Pharmacovigilance Legislation on International Companies by Steve Jolley

About the training

#safety   #EU requirements   #PV inspection

In July 2012, pharmacovigilance legislation came into effect across the EU as a result of changes set out in:

The legislation was underpinned by a series of modules on Good Pharmacovigilance Practice.

Are you confident your pharmacovigilance operations will meet the EU’s expectations for compliance?  Does your company understand the processes needed to perform adequate risk assessment? 

Your product could suffer significant consequences if your company does not have the proper systems and processes in place.  Attendees of this course will gain a better understanding of how to work to meet EU standards and will be better prepared to implement regulatory requirements for signaling and risk management.

This course is designed to give pharmaceutical and biologic companies operating in the EU an introduction to European pharmacovigilance requirements and provide important updates.

Learning outcomes

Drug Safety

Discuss the new EU regulatory requirements for drug safety

Adverse Events

Describe how to process adverse events to meet EU requirements

PV Inspection

Explain what to expect in a European PV inspection


  • What is Europe? EU, EEA, EFTA

  • EU regulatory framework

  • Ongoing time frame for implementation of the new legislation

  • Transition from Volume 9A

  • GVP modules and implementing measures

  • Pharmacovigilance Risk Assessment Committee (PRAC)

  • Quality systems

  • Audit and inspection

  • PV System Master File (PSMF)

  • ADR reporting

  • Periodic Safety Update Report/ Periodic Benefit-Risk Evaluation Report

  • Signal management

  • Risk Management Plans: risk assessment and risk minimization

Main benefits

  • #Wide collection of the biggest experts
  • #Filters for all kinds of needs
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  • #Fast and cheap
  • #Highest level of proficiency