Pharmacovigilance in Europe: Impact of Regulatory Changes on Investigational & Marketed Products

Upcoming Courses

Course #: SPVA1116
November 16-17, 2016
The Hub Meeting Center - CityView
Philadelphia, PA
Take advantage of our $1,595.00 price by registering early!
* After October 14, costs are $1,795.00.

Course Description

The ICH process has resulted in multiple initiatives aimed at harmonizing global regulatory requirements for the approval and marketing of pharmaceuticals.  The EU has faced the additional challenge of harmonizing disparate regulations and practices across multiple cultures and languages. This course will cover the essential ICH pharmacovigilance guidelines for investigational and marketed products, as they have been being implemented in Europe.    The current Volume 9A and Volume 10 nd the implications of the new EU marketed product guidelines will be discussed in detail, including:

  • Expedited and periodic reporting of safety information
  • Pharmacovigilance and risk mitigation plans
  • The role of the Qualified Person for Pharmacovigilance (QPPV)
  • EU PV inspection requirements
  • Use of the EudraCT and Eudravigilance databases
  • Safety data exchange within licensing agreements
  • Representation of safety information in the Summary of Product Characteristics

Differences from US regulatory requirements and additional local requirements will also be discussed. This course will give US pharmacovigilance personnel a working knowledge of exisiting and evolving EU pharmacovigilance requirements and an overview of the processes and procedures needed to ensure compliance with them.

Learning Objectives

  • Review the regulatory reporting requirements of the EU Clinical Trials Directive (Volume 10) and Volume 9A for companies which develop or market products in Europe
  • Utilize the tools and mechanisms set up by the EU to enable and assist regulatory compliance
  • Review the extensive pharmacovigilance inspections now being conducted by Competent Authorities, their findings, and the sanctions that can be imposed upon companies and individuals
  • Recognize the challenges facing European pharmacovigilance employees of non-EU companies
Who Should Attend

  • Clinical trial safety personnel responsible for multinational clinical trials, as well as safety personnel involved with global post-marketing safety responsibilities
  • Pharmacovigilance personnel involved in auditing of company compliance
  • Safety personnel responsible for safety data analysis, and for updating safety in the company labels

The course will be led by one of the following instructors:

Sidney N. Kahn, M.D., Ph.D.

Click here for complete trainer biographies

Course Outline

Day 1: 8:30 a.m. – 5:00 p.m.

  • Understanding the EU Pharmacovigilance Requirements and Current Interpretation

Day 2: 8:30 a.m. – 5:00 p.m.

  • Developing the Processes and Procedures Necessary for Compliance

Interactive Activities

  • Shared experiences
  • Group discussions

Registration Fees

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.

Click here for our seminar cancellation policy

Accreditation Information

ACPE LogoBarnett 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# 0778-0000-12-004-L01-P. Released: 4/12.

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471.