Introduction to Drug Safety – US and EU Requirements
by Steve JolleyLanguages: English
Price (from): €6,000 / day
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.
Please login to send a message
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
(PSMF)
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
Program
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
CIOMS
...
Main benefits
- #Wide collection of the biggest experts
- #Filters for all kinds of needs
- #User friendly platform
- #Fast and cheap
- #Highest level of proficiency