A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!
The European Pharmacovigilance Legislation
Upcoming Courses
In July 2012, pharmacovigilance legislation went into effect across the European Union (EU) as a result of changes set out in Regulation (EU) No1235/2010: and Directive 2010/84/EU. The legislation is underpinned by a European Commission (EC) Implementing Measures Regulation and a series of modules on Good Pharmacovigilance Practice. Are you confident your pharmacovigilance operations will meet the EU’s latest expectations for compliance? Do you understand the processes needed to perform adequate risk assessment?
Not knowing which systems and processes you must have in place for the European pharmacovigilance requirements could have significant consequences for your product. You must be sure you have the understanding you need to be able to work to EU standards and have implemented regulatory requirements for signaling and risk management. This web seminar is designed to give pharmaceutical and biologic companies operating in the EU an introduction to the European pharmacovigilance requirements. We will address: Audits and inspections; ADR reporting and signal management; Periodic Safety Update Reports; risk minimization; Risk Management Plans; and post authorization studies.
- Navigate the EU regulatory requirements for drug safety
- Process Adverse Events to meet EU requirements
- Prepare for an European pharmacovigilance inspection
- Drug Safety and Pharmacovigilance Personnel
- Regulatory Affairs Professionals
- Clinical Development Staff
- Executives (including C-Level) with any legal responsibility for drug safety
Steve Jolley
Click here for complete trainer biographies
$695
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 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#: 0778-0000-12-067-L01-P. Released: 7/12.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.
