Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance

Upcoming Courses

Course #: SSVA0614
June 24-25, 2014
The Hub Meeting Center - CityView
Philadelphia, PA
Take advantage of our $1,595.00 price by registering early!
* After May 23, costs are $1,795.00.

Course Description 

This course will deliver an introduction to the basics of drug safety and pharmacovigilance, including regulatory requirements, adverse event reporting, signaling and risk management. This course addresses the regulatory issues across global government agencies that improve safety, but slow down the product approval process. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence, and regulatory compliance. This course will provide learners with the regulatory references, processes, best practices, and analysis and investigation techniques to minimize risk, avoid product recall, and meet international safety and reporting standards. 

Learning Objectives 

  • Work to international standards by meeting regulatory requirements for product safety 
  • Perform signaling and risk management functions 
  • Collect, assess, report, and analyze adverse events 
  • Create signaling analyses based on FDA Good Pharmacovigilance Practices 
  • Identify differences between US and European legal requirements 
Who Should Attend

  • Drug Safety Professionals 
  • Pharmacovigilance Staff 
  • Regulatory Affairs Professionals 
  • Clinical Development Staff 

Steve Jolley 

Click here for complete trainer biographies

Course Outline 

Day 1: 8:30 a.m. – 5:00 p.m. 

  • Overview of Pharmacovigilance: Thalidomideand History of Pharmacovigilance; Limitations of Pre-approval Clinical Trials; Post-Marketed AEs; Pharmacovigilance Definitions; Assessing Adverse Events; Serious vs. Severe; Causality; Expectedness; SUSAR; Minimum Criteria for Reporting; Reporting Format; Managing Blinded Therapy Cases; Sponsor Responsibilities; Monitor Responsibilities; Principal Investigator Responsibilities; Adverse Reaction Types; Safety Signal Generation 

Day 2: 8:30 a.m. – 5:00

  • Pharmacovigilance Compliance: Matrix of Safety Regulations; International Conference on Harmonisation (ICH); CIOMS; Key EU Components; EU Member States; Eudravigilance; EU Clinical Trial
    Directive; Volume 10; Volume 9A; European Signaling Regulations; ASR, IND, DSUR reports
  • PV Audits - Preparing for a Pharmacovigilance Audit; Achieving Best Practices; Scope; PV Checklist; Case Studies; Eight Domains of PhV; Key Findings by MHRA; Quiz on Regulations & Compliance
  • Signaling & Risk Assessment: Need for Signal Detection; the Cost of Failure; Regulatory Requirements for Signaling; EMEA Signaling Legislation; MHRA & Signal Detection; Approach to Signal Detection; Sample Signaling Analyses; Methodologies: MGPS, BCPNN, PRR; Signaling Process; Product Safety Profile; Risk Management Planning; Quick Quiz for Signaling 

Interactive Activities 

  • Signaling Exercises: Analysis of PSUR data by MedDRA System Organ Class, Preferred Term, Age Range, Sex, Country, Time to Onset, and Concomitant Medications 
  • Quiz on "The Pharmacovigilance Audit" 


Registration Fees

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day. 

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings. 

Click here for our seminar cancellation policy 

Accreditation Information

ACPE LogoBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE# 0778-0000-12-041-L04-P. Released: 9/12. 

Hold this course at your company! 

For more information, contact Naila Ganatra at (215) 413-2471. 


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On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
For details on our scenario-based practical GCP application on-demand course, click here.

GCP for Investigators

Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

For more details on this scenario-based eGCP program for investigators please click here. 

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