This 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 US 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 US and EU safety reporting standards.
- Meet regulatory requirements for product safety
- Perform signaling analysis and risk assessment and management functions
- 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 instructors:
Susan Gordon, R. N., M.S.N.
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Day 1: 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 efficacy; pharmacovigilance
- Global Regulatory References and Expectations: Global regulations addressing safety (ICH, CIOMS, FDA and EU)
- Quality Processes: Case metrics; quality assurance audit
- Clinical Trial Safety Data Collection: Audit trail; safety data management; statistical analysis; communication of safety information
Day 2: 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 actions
- 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 Signaling Reviews
- Analysis of PSUR data by MedDRA System Organ Class, Preferred Term, Age Range, Sex, Country, Time to Onset, and Concomitant Medications
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.
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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# 0778-0000-12-041-L04-P. Released: 9/12.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.