course covers the fundamentals of drug safety and pharmacovigilance, including
regulatory requirements, adverse event reporting, signaling and risk
management. The course addresses the regulatory issues across U.S. and EU
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
regulatory references, processes, best practices, and analysis and
investigation techniques to minimize risk, avoid product recall, and meet U.S.
and EU safety reporting standards.
- Describe regulatory requirements for product
- Perform signaling analysis and risk
assessment and management functions
- Define how to collect, assess,
report, and analyze adverse events
- Create signaling analyses based on
FDA Good Pharmacovigilance Practices
- Identify differences between U.S.
and European regulatory requirements
- Drug Safety and Pharmacovigilance Professionals
- Regulatory Affairs Professionals
- Senior Level Executives
- Clinical Development Staff
The course will be led by one of the following
Click here for complete trainer
Day One: 8:30 a.m. – 5:00 p.m.
- What is Pharmacovigilance?: Definition and history; corporate pharmacovigilance;
ADR system; critical elements
- What is an Adverse Event Drug Reaction?: Adverse Drug Reaction definition; sources of SADRs;
types of ADRs; ADR reports to FDA/EMEA; serious ADR; unlabeled or unexpected
ADR; expectedness “listed” vs. “unlisted”; severity/intensity; lack of
- Global Regulatory References and Expectations: Global regulations addressing safety (ICH, CIOMS, FDA
- Quality Processes: Case metrics; quality assurance audit
- Clinical Trial Safety Data Collection: Audit trial; safety data management; statistical analysis;
communication of safety information
Two: 8:30 a.m. – 5:00 p.m.
- Signaling: What is safety signal; safety signal generation;
definition; pharmacovigilance process; risk/benefit; situations for signal
detection; sources of signals; analysis and investigation of a signal;
understanding safety signals; suspected signals, risk assessment
- PV Audits and Audit Issues: Regulatory inspections; preparation, problems and issues;
checklists; ADR; inspection principles; inspection results; potential regulatory
- Characteristics of a Good Case Report: How to do a narrative evaluation for follow-up; active
query; investigator’s brochure; safety; interim update for investigators;
FDA time/report obligations; regulatory reporting and notification
- Case Study Reviews
- Exercises in Drug Safety and
- Analysis of PSUR data by MedDRA
System Organ Class, Preferred Term, Age Range, Sex, Country, Time to
Onset, and Concomitant Medications
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
Barnett 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
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-18-033-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1