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

More documents

Recommendations

Info

EuroMeeting Special Programmes Maureen McGahan is the Special Programmes Coordinator in the EuroMeeting team. Please contact Maureen for further information about any of the programmes detailed underneath: maureen.mcgahan@diaeurope.org or call +41 61 225 51 60. EuroMeeting Guidance Programme The DIA is committed to the active participation of students and emerging professionals in the EuroMeeting and to maximising the quality of their experience while attending the meeting. DIA will match students and young professionals with an experienced professional and coordinate a short meeting whilst in Monaco to share views, ideas and experience. • Benefits for the student/young professional include an opportunity to learn from an experienced professional • Benefits for the experienced professional include an opportunity to share experience and expertise Student Poster Abstracts: Deadline November 25, 2009 A maximum of 20 abstracts are selected for the student poster presentation and a total of € 1,800 in prize money will be awarded to student winners. Benefits include one fully supported registration for the EuroMeeting to include: return flight to Monaco, three nights’ hotel accommodation and complimentary registration for the EuroMeeting. Professional Poster Abstracts: Deadline November 25, 2009 A maximum of 40 abstracts from full-time professionals will be selected for the professional poster presentations. Selected professional poster presenters will be required to attend the meeting and pay the applicable registration fee and will be responsible for all other meeting expenses. Young Professional Fellowship: Deadline November 25, 2009 DIA welcomes the involvement of emerging professionals in the EuroMeeting and provides complimentary admission to the EuroMeeting for 15 young professionals under the age of 30 in full-time employment. Student Fellowship: Deadline November 25, 2009 DIA welcomes the involvement of students in the EuroMeeting and is providing complimentary admission to the EuroMeeting for 15 students in full-time education. Patient Fellowship: Deadline November 25, 2009 The DIA Patient Fellowship, now in its fifth successful year, is a programme to promote the participation of patients’ organisation representatives in the EuroMeeting. DIA fully supports 22 patient representatives covering travel, accommodation and complimentary meeting registration and is offering 25 additional patient representatives complimentary registration for the EuroMeeting. 10 Share your knowledge! Are you planning on attending the EuroMeeting in Monaco (March 8-10, 2010)? Are you an experienced professional? Are you willing to spare a couple of hours to offer guidance to a student or young professional during the EuroMeeting? If your answers are yes to all of the above, then the EuroMeeting team would love to hear from you. The EuroMeeting Guidance Programme puts students and young professionals in touch with experienced professionals at the EuroMeeting. The time commitment will be as much as you are able to offer, but a minimum of two hours’ contact with a student/young professional would be appreciated. It could involve activities such as attending the special networking lunchtime reception on Monday, March 8, 2010, spending some time reviewing the programme or perhaps attending a session together and discussing the content afterwards. This is a great opportunity to invest in the future of the pharmaceutical profession by sharing your expertise and experience. Please contact Maureen McGahan in the EuroMeeting team for further information about how you can get involved (email maureen.mcgahan@diaeurope.org or call +41 61 225 5160).
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
Page 1 and 2: 22nd Annual E UROM EETING Monaco 20
Page 3 and 4: Welcome from the EuroMeeting 2010 C
Page 5 and 6: Plan Your EuroMeeting Experience! S
Page 7 and 8: Special Sessions Student and Young
Page 9: Session Topics in Specific Interest
Page 13 and 14: This is a preliminary programme. Ne
Page 17 and 18: Greening the EuroMeeting: Towards a
Page 39 and 40: discovery and development. This is
Page 46 and 47: Exhibit at the EuroMeeting 2010 46
Page 48 and 49: Monaco - Surprisingly Affordable Ho
Page 50 and 51: 50 Networking Opportunities Network
Page 52 and 53: Monday, March 8, 2010 Session 1 16:
Page 54 and 55: heme 11 Theme 12 Theme 13 Health si
Page 56: REGISTRATION FORM ID# 10101 22nd An

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

Create successful ePaper yourself

Delete template?

Save as template?