Pre-Conference Tutorials, Monday, March 8, 2010, 09:00
Pre-Conference Tutorials, Monday, March 8, 2010, 09:00
Pre-Conference Tutorials, Monday, March 8, 2010, 09:00
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This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.<br />
to the Agency’s Road Maps, the Heads of Agencies released their Strategy<br />
Paper setting out the ambition for National Competent Authorities in the future.<br />
Stakeholders are interested in the resources that are available to support the<br />
Decentralised and Mutual Recognition Procedure and how they will be<br />
allocated. Industry sees much to gain in a dialogue with regulators. Ways that<br />
dialogue may be enhanced to the benefit of both industry and Agencies will be<br />
explored so that creative suggestions can be offered for further discussion.<br />
Recognising that the approval of a marketing application is the first step to the<br />
availability to patients of a medicine, the vital role and contribution of Health<br />
Technology Assessment bodies will be presented so that the interaction<br />
between the two organisations can be understood by stakeholders.<br />
Europe is one of the three major pharmaceutical markets in the world and<br />
cooperation between regulatory agencies in these countries and others are<br />
important for public health.<br />
<strong>Monday</strong>, <strong>March</strong> 08, <strong>2010</strong><br />
16:30 Session 0801<br />
PHARMACEUTICAL PACKAGE - THE LATEST INFORMATION<br />
Session Chair:<br />
Truus Janse-de Hoog, Staff member MEB, European Cluster, Chair CMD(h),<br />
Medicines Evaluation Board, The Netherlands<br />
The European Commission adopted three legislative proposals in December<br />
2<strong>00</strong>8: “The Pharmaceutical Package”.<br />
The aim of the package:<br />
• to tackle the growing issue of counterfeiting and illegal distribution of<br />
medicines<br />
• to better protect patients by strengthening the EU system for safety<br />
monitoring of medicines<br />
• to enable citizens to get high quality information on prescription-only<br />
medicines.<br />
The legal proposals are being discussed at the Council Working Party on<br />
Pharmaceuticals and Medical Devices and also in the European Parliament (EP).<br />
A representative from the European Commission and the Council Working Party<br />
will give an update on the current status. What are the main points for<br />
discussion and what is the expected timeframe for discussion? A representative<br />
from industry will present their view on the legislative proposals.<br />
European Commission Perspective<br />
Martin Terberger, Head of Pharmaceuticals Unit, DG Enterprise and Industry,<br />
European Commission, EU<br />
The Pharmaceutical Package: An update from discussions in the Council<br />
Working Party<br />
Johan Lindberg, Deputy Director, Ministry of Health and Social Affairs, Sweden<br />
The Pharmaceutical Package: A view from the industry<br />
Meni Styliadou, Head, European Public Affairs, Novartis, Belgium<br />
Tuesday, <strong>March</strong> <strong>09</strong>, <strong>2010</strong><br />
<strong>09</strong>:<strong>00</strong> Session 0802<br />
INTERNATIONAL COOPERATION AMONG REGULATORY AGENCIES<br />
Session Chair:<br />
Marie A. Dray, <strong>Pre</strong>sident, International Regulatory Affairs Group LLC, USA<br />
For the last few years, reports on privileged discussions among regulators on<br />
topics such as Regulatory Simplification under the auspices of the Transatlantic<br />
Dialogue, have been provided publicly at DIA Annual and EuroMeetings.<br />
This session will update the audience, to the extent not limited by<br />
confidentiality, on the current status of bilateral discussions between the EU/<br />
European Medicines Agency and the US FDA on Regulatory Simplification and<br />
Theme 8<br />
other current topics. In addition, a spokesperson for the ICH (International<br />
<strong>Conference</strong> on Harmonisation) will be invited to report on the status of<br />
communications under the ICH umbrella and the future of ICH. Finally, each<br />
speaker will be invited to answer candid questions from the audience on topics<br />
presented, as well as on related regulatory topics which might have been<br />
reported, elsewhere.<br />
European Medicines Agency Perspectives on Regulatory Cooperation and<br />
Communications<br />
Thomas Lönngren, Executive Director, European Medicines Agency, EU<br />
FDA’s Views on Continued Cooperation among Regulatory Authorities, under<br />
the New US Administration<br />
Murray Lumpkin, Deputy Commissioner, International and Special Programs,<br />
OC, FDA, USA<br />
The Value and Benefit of the ICH to Regulators—The CTD, the Common<br />
Regulatory Language<br />
Justina A. Molzon, Associate Director for International Programs, CDER, FDA,<br />
USA<br />
11:<strong>00</strong> Session 0803<br />
HEADS OF MEDICINES AGENCIES<br />
Session Chair:<br />
Craig McCarthy, Managing Director, CAMPHARM, France<br />
This session will focus on the HMA strategy paper and some topical regulatory<br />
challenges and initiatives that the HMA are pursuing as part of their strategy.<br />
The speakers in this session, who are key leaders of their respective national<br />
regulatory agencies, will outline some of the challenges from this decade and<br />
initiatives for the next decade in the development of this strategy.<br />
HMA Strategy Paper<br />
Kent Woods, Chief Executive, MHRA, UK<br />
HMA Initiatives on Clinical Trials<br />
Jean Marimbert, Director General, Afssaps, France<br />
HMA Initiatives on Resourcing<br />
Jytte Lyngvig, Chief Executive Officer, Danish Medicines Agency, Denmark<br />
14:<strong>00</strong> Session 0804<br />
CHANGES IN REGULATORY AGENCIES TO MEET FUTURE CHALLENGES<br />
Session Chair:<br />
Thomas Kühler, Regulatory Affairs Specialist, Sweden<br />
The regulatory landscape is under constant change as agency workload is ever<br />
increasing and new scientific committees are created. Additional pieces of<br />
legislation are put in place, the different marketing authorisation procedures are<br />
extensively used and new work-bits, funded or not, are emerging. This session<br />
will focus on the relationship between the different scientific committees, how<br />
the work content is transformed and measures taken by regulatory agencies to<br />
cope with these changes. The session will also explore what Industry’s<br />
expectations on the agencies in those resource-demanding times are.<br />
Architecture of European Medicines Agency Scientific Committees and their<br />
relationship with National Agencies – the Commission Perspective<br />
Martin Terberger, Head of Pharmaceuticals Unit, European Commission, EU<br />
Swissmedic’s Reorganisation: Mission Accomplished?<br />
Cordula Landgraf, Head of Networking, Swissmedic, Switzerland<br />
What Industry Wants from Regulatory Authorities<br />
Julian Thompson, Vice <strong>Pre</strong>sident, Worldwide Regulatory Strategy, Pfizer Ltd.,<br />
UK<br />
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