Agenda at a Glance

This tutorial will provide an in-depth overview of the clinical safety and postmarketing pharmacovigilance inspectional approaches of the US FDA and EU Member State regulatory agencies (e.g., MHRA) who serve as lead inspectorates for EMEA. How to craft effective, inspection-ready procedural documents, the relationship between quality processes and compliance, and how companies can prepare for inspections from regulators of both regions will be addressed.

At the conclusion of this tutorial, participants should be able to:

• Compare and contrast US and EMEA inspectional approaches in clinical safety and postmarketing pharmacovigilance
• Describe the attributes of effective procedural documents
• Explain how companies can be prepared for safety-related regulatory inspections

Workshop Leaders
Elliot G. Brown, MB, ChB, BMedSci, MRC GP, FFPM, Managing Director, Elliot
Brown Consulting Ltd., Director, PrimeVigilance Ltd., Former Member, Pharmacovigilance Working Party, EMEA

This tutorial will examine the challenges in performing effective premarketing clinical safety, postmarketing pharmacovigilance and risk management for those who have joined a safety department in a global company, particularly one with many national affiliates. Issues such as coordinating local and international procedures, safety databases, language barriers, diverse regulatory requirements, cultural differences and contractual variations among regions will be addressed.

At the conclusion of this tutorial, participants should be able to:

• Define roles and responsibilities within local and international safetyrelated processes and procedures in a global company without losing sight of the “big picture”
• Understand issues involved in effective and compliant use of a global safety database
• Discuss the importance of ongoing education and training in a global company, and why it’s needed as part of continuous improvement and motivation
• Discover techniques for ensuring quality management and compliance.

Workshop Leaders
Brian Edwards, MB MD, MRCP, Scientific Advisor, Pharmacovigilance and Drug Safety, NDA Regulatory Science Limited, UK, Former Deputy EU Qualified Person for Pharmacovigilance, Janssen-Cilag UK
L. Paul Starkey, MD, FAAFP, Executive Director , Medical Affairs - Americas, PRA International

Shinya Yamauchi, Operating Officer, Otsuka Pharmaceutical Co.
Asia/Pacific Rim Presenter TBD

Moderator: Brian Edwards, MB MD, MRCP, Scientific Advisor, Pharmacovigilance and Drug Safety, NDA Regulatory Science Limited, UK
Panelists: Stephen A. Goldman, MD, FAPM, DFAPA • Maria Grazia Zurlo, MD • Shinya Yamauchi • Jeffrey Shuren, MD, JD (invited)

Marcia Gelber, Pharmacist, Division of Compliance Risk Management and Surveillance, Surveillance and Data Analysis Branch, Office of Compliance, CDER, FDA
Maria Grazia Zurlo, MD,

Shinya Yamauchi

Moderator: Stephen A. Goldman, MD, FAPM, DFAPA

Panelists:

Elliot G. Brown, MB, ChB, BMedSci, MRC GP, FFPM

Brian Edwards, MB MD, MRCP

Terry Crowley, RN, MS

Andrew Bate, PhD, MA