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.
- 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
Drug Safety Professionals
Regulatory Affairs Professionals
Clinical Development Staff
The course will be led by one of the following instructors:
Click here for complete trainer biographies
Day 1: 8:30 a.m. – 5:00 p.m.
- Session 1 - Overview of Pharmacovigilance: Thalidomide and 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’s Responsibilities; Sponsor’s Responsibilities; Monitor Responsibilities; Principal Investigator Responsibilities; Adverse Reaction Types; Safety Signal Generation.
Day 2: 8:30 a.m. – 5:00 p.m.
- Session 2 – 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.
- Session 3 - 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.
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 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 Elizabeth Andrews 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 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.