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Introduction to Drug Safety – US and EU Requirements

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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Introduction to Drug Safety – US and EU Requirements by Steve Jolley

About the training

#drug safety essentials   #global regulatory requirements

Product safety makes headlines every day -- and the impact on a company’s image, consumer confidence, and Wall Street’s opinion are profound.  Are you confident your current pharmacovigilance operations will meet the latest US and EU expectations for compliance and keep your products on the market?  Do you understand the processes needed to perform adequate risk assessment? 

Not knowing which systems and processes you must have in place for your own safety reporting could mean you miss an important issue with significant consequences for your product. You must be sure you have the understanding you need to avoid product recall, are able to work to international standards and have implemented regulatory requirements for signaling and risk management.

This training course is designed to give pharmaceutical and biologic companies operating in the US and EU an introduction to the fundamentals of product safety and regulatory compliance. The course will include case studies of adverse events to illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities.

Learning outcomes

Drug Safety

An understanding of regulatory requirements for drug safety; Requirements for quality oversight of drug safety


Contents of the PV System Master File (PSMF)

Regulatory Framework

Overview of US and EU regulatory framework, including details of EU GVP modules

Gain Knowledge

Knowledge of how to collect, assess, report and analyze adverse events; An engaging and experienced instructor; Requirements for signal management


  • Module 1 – Drug Safety Essentials

  • Learning Objectives for this Session

  • History of Pharmacovigilance

  • Pre-Marketed AEs

  • Post-Marketed AEs

  • Pre- and Post-marketing: Basic Differences

  • The Importance of Adverse Event Reporting

  • Pharmacovigilance Definitions

  • ICH Definition of Adverse Event

  • ...

  • Module 2 - Global Regulatory Requirements

  • Legalities - EU

  • FDA Regulations

  • New FDA Regulation for IND safety reporting

  • IND Annual Report

  • Literature Reporting

  • International Conference on Harmonisation (ICH)

  • ICH Topic Codes and Reports


  • ...

Main benefits

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