Product safety makes headlines every day -- and the impact on a company’s image, consumer confidence, and Wall Street’s opinion is 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.
- Gain an understanding of regulatory requirements for drug safety
- Describe how to collect, assess, report, and analyze adverse events
- Explain how to create signaling analyses based on FDA Good Pharmacovigilance Practices
- Describe the basic elements required for performing adequate risk assessment
Almost everyone involved in drug development and marketing needs to know the basics of FDA’s regulations regarding drug safety. Staff who will benefit include:
- Drug safety and pharmacovigilance
- Regulatory Affairs
- Clinical Development
- Executives (including C-Level) with any legal responsibility for drug safety
Click here for complete trainer biographies
Day 1: 8:30 a.m. – 5:00 p.m.
- 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; Expedited and Aggregate Reports; Reporting to IRB/ECs; Minimum Criteria for Reporting; Managing Blinded Therapy Cases; Adverse Reaction Types; Safety Signal Generation; Quiz
- Global Regulatory Requirements: Matrix of Safety Regulations; FDA 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; New EU PV Legislation; Quiz
Day 2: 8:30 a.m. – 5:00
- PV Audits: Preparing for a Pharmacovigilance Audit; Achieving Best Practices; Scope; PV Checklist; Case Studies; Eight Domains of PV; Key Inspection Findings by FDA &MHRA; Quiz
- Signaling & Risk Assessment: Need for Signal Detection; the Cost of Failure; Regulatory Requirements for Signaling; EMA Signaling Legislation; MHRA & Signal Detection; Approach to Signal Detection; Sample Signaling Analyses; Methodologies: MGPS, BCPNN, PRR; Signaling Process; Quiz
- Communicating Safety Issues: Pharmacovigilance process; Product Safety Profile; Risk Management Plan-ning; EU RMP vs FDA REMS, EU RMP format, FDA REMS Elements
- Case assessment: seriousness, severity and causality
- Signaling Exercises: Analysis of AE 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.
Click here for our seminar cancellation policy
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.