Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

Pre-Conference Tutorials, Monday, March 8, 2010, 09:00 - 12:30
ROUNDTABLE DISCUSSION 1 *
This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.
GCP INSPECTION AND AUDIT FINDINGS
Beat Widler, Global Head of Clinical Quality Assurance, F. Hoffmann-La Roche
Ltd., Switzerland
Fergus Sweeney, Head of Compliance and Inspection, European Medicines
Agency, EU
During the course of GCP Inspections some important themes are identified by
the inspectors as being common to multiple inspections. In a similar way GCP
auditors working for industry identify key issues of concern. This roundtable
provides an opportunity to identify and discuss some of these key findings with
a panel of GCP inspection experts from regulatory authorities and GCP audit
experts from industry/academia. The topics selected for discussion will be
chosen, by the panel, from responses to a short questionnaire circulated to
registered participants.
Discussion Objectives
The purpose of this roundtable is to provide an opportunity for open, timely
discussion of key GCP issues arising from inspection and audits:
• Establish a common understanding of inspection and audit findings and their
basis in regulation, guidance and quality principles
• Build consensus on the priority issues for resolution
• Better evaluate audit and inspection findings and their impact on GCP
compliance and the ethical and scientific validity of clinical trials
• Update on new issues/initiatives of regulators and of auditors
Target Audience
GCP compliance auditors and management, and staff with GCP-related QC
responsibilities from both industry and academia; clinical research management
and project leaders from both industry and academia; GCP inspectors
* special roundtable price € 75.00 + VAT
TUTORIAL 2
HOT TOPICS IN PHARMACOVIGILANCE IN THE EU: EUDRAVIGILANCE
ACCESS POLICY, INTERNATIONAL STANDARDISATION WORK E2B AND
IDENTIFICATION OF MEDICINAL PRODUCTS, SIGNAL DETECTION,
DUPLICATE MANAGEMENT
Sabine Brosch, Scientific Administrator, Pharmacovigilance and Risk
Management, European Medicines Agency, EU
Gaby Danan, Expert in Pharmacovigilance, Senior Director, Global
Pharmacovigilance and Epidemiology, sanofi-aventis, France
This tutorial has been prepared to provide attendees with an overview on
current hot topics in pharmacovigilance in the EU. The attendees will be offered
the opportunity to discuss the latest developments related to the
implementation of the new EudraVigilance Access Policy, the finalisation of the
new international standards related to Individual Case Safety Reports (ICSR)
and the Identification of Medicinal Products (IDMP), practical approaches in
signal detection and duplicate management in the light of recent inspection
findings.
Learning Objectives
At the conclusion of this tutorial, attendees will be able to:
• Recognise the latest developments in obtaining access to EudraVigilance
• Identify the main changes related to E2B and the reporting of medicinal
product information
• Discuss approaches in signal detection and duplicate management
Target Audience
EU QPPV; people responsible for pharmacovigilance; people responsible for
regulatory affairs; people responsible for Quality Assurance (clinical); people
responsible for data management and systems operation in pharmacovigilance
TUTORIAL 3
GOOD VIGILANCE PRACTICES – HOW DO CONTINUOUS IMPROVEMENT,
AUDITS AND INSPECTIONS CONTRIBUTE?
Monika Pietrek, Managing Director, Pietrek Associates GmbH, Germany
In view of the pharmaceutical package and existing obligations, this tutorial will
review core safety processes and the associated quality management system
including key performance metrics and regulatory feedback today and in the
future. Regulatory authorities are increasingly enforcing work-intensive
regulatory requirements in drug safety, while in parallel other initiatives strive
for good pharmacovigilance practices. At the same time the pharmaceutical
industry and their service providers are undergoing tremendous change and
consolidation. Given the complexity of these tasks, the individual responsible
for safety in pharmaceutical and biotech companies is overwhelmed by the
need to adjust working practices to ensure compliance. Subject matter experts
from both industry and regulatory will advise on the development of a frame
work for best working practices from a pragmatic and cost-efficient
perspective. Key elements will include process design and review, quality
management, metrics, usefulness of audits and practical considerations for
inspections. Options for organisational solutions will be presented and assessed
for their implications on pharmacovigilance, including whether or not the
concept of quality control and quality assurance supports the safety and wellbeing
of patients as well as the transformation of the work environment into a
collaborative, transparent and proactive entity.
Learning Objectives
At the conclusion of this tutorial, attendees will be able to:
• Recognise the interaction and balance between drug safety processes and
quality management
• Discuss the validity of performance metrics
• Analyse regulatory feedback
Target Audience
Personnel working in drug safety /pharmacovigilance, QA and regulatory affairs
in industry and at regulatory agencies
TUTORIAL 4
FROM PRESENT TO FUTURE: PSUR REGULATORY AND SCIENTIFIC
CHALLENGES
Giovanni Furlan, Head, Global Product Safety Analysis & Evaluation, Bracco
Imaging SpA, Italy
Carol Markwell, Director, Drug Safety Solutions, UK
According to the European Commission, PSURs are currently only “line listings
of adverse reactions”. An integrated “holistic” approach is needed for preparing
PSURs: these are regulatory documents having a scientific scope. Therefore, the
main PSUR regulatory and scientific challenges such as signal detection and
evaluation, benefit/risk balance, cross links with other regulatory documents
and PSUR planning will be discussed. Since multiple departments contribute in
PSURs, it will also be illustrated how to streamline their preparation by applying
human factor principles.
Learning Objectives
At the conclusion of this tutorial, attendees will be able to:
• Recognise PSUR limits and scope
• Adapt and comply with new PSUR requirements
• Plan and streamline PSUR preparation
• Perform benefit-risk evaluation in the context of a PSUR
Target Audience
Medical writers; drug safety personnel involved in PSUR preparation, signal
detection and benefit/risk evaluation. People from other departments involved
in PSUR preparation may benefit from this tutorial.
11