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US Drug Safety and FDA Inspection Readiness

by Steve Jolley

Languages: English

Price (from): €6,000

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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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US Drug Safety and FDA Inspection Readiness by Steve Jolley

About the training

#inspections   #audit   #quality management   #clinical oversight   #FDA regulatory

This training course is designed to give pharmaceutical and biologic companies operating in the US an introduction to the fundamentals of product safety and regulatory compliance.  It will also give you a jump-start on how to prevent common problems that are found during regulatory inspections for drug safety and pharmacovigilance.  It will include examples based on the top ten findings by FDA pharmacovigilance inspectors.  You will be able to use this information straight away to make the changes you need to address these common failings and avoid the findings.

You can be sure regulatory authorities will inspect your drug safety operations - and there is no excuse for poor preparation.

This training course is designed to give pharmaceutical firms operating in the US practical information, best practices and insight to help ensure compliance with the most recent drug safety and pharmacovigilance regulations.

Learning outcomes

FDA Regulatory

An understanding of FDA regulatory requirements for drug safety; Knowledge of how to collect, assess, report and analyze adverse events to meet FDA requirements

US Regulatory Framework

Overview of the US regulatory framework

FDA Inspections and Audit

The top ten findings from FDA pharmacovigilance inspections; The objectives and components of a pharmacovigilance audit

Practical Steps

Practical steps to help you begin and implement your audit; Examples of what NOT to do

Program

  • Whether you're planning an internal audit of your processes, anticipating an audit from a business partner, or preparing for your FDA inspection, this course will give both old hands and new staff the insights needed to be ready for regulatory scrutiny of

Main benefits

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