Cooperation Among Regulators: Impact on Stakeholders

Hear Firsthand from FDA Commissioner Hamburg, EMA Executive Director Rasi, and Health Canada Assistant Deputy Minister Glover             View Commissioner Hamburg at Last Year's Annual Meeting Cooperation Among Regulators: Impact on Stakeholders Monday, June 24 Hear views on important issues from the leaders of three of the most influential drug regulatory agencies: The Health Products and Food Branch of Health Canada, the European Medicines Agency, and the U.S. Food and Drug Administration. Join the regulators as they discuss current actions in public policy resulting from interagency actions and strategic communication. Speakers: Chairpersons: Paul Glover, MBA Assistant Deputy Minister of the Health Products and Food Branch Health Canada Marie Allison Dray, MA, MBA President International Regulatory Affairs Group LLC Margaret A. Hamburg, MD Commissioner, FDA  Murray M. Lumpkin, MD, MSc Commissioner's Senior Advisor and Representative for Global Issues, OC, FDA Guido Rasi, MD Executive Director European Medicines Agency European Union Late Breaker Sessions Collaborating to Streamline Drug Development: Are We Making Progress? Wednesday, June 26 In this forum, leaders of two of the best known initiatives – TransCelerate Biopharma Inc (TransCelerate) and the Clinical Trials Transformation Initiative (CTTI) – will provide a status report on current projects, with additional perspectives provided by representatives of the FDA, CROs, and research sites. TransCelerate’s Collaborative Approach to Risk-based Monitoring: The Methodology Wednesday, June 26 TransCelerate BioPharma Inc. (TransCelerate) developed a methodology for monitoring that shifts monitoring processes from an excessive concentration on source data verification to comprehensive risk-driven monitoring. This philosophical shift in monitoring processes employs centralized and offsite mechanisms to identify and monitor important study parameters holistically and uses adaptive onsite monitoring to further support subject safety and data quality. White Paper Showcase features the following two opportunities... Stay Tuned, More to Come! Next Generation Medical Information Call Center Tuesday, June 25 This session will discuss best practices for building a next generation medical information call center that expediently and efficiently delivers medical information on a global scale. We will discuss how advanced technology can enable and enhance critical patient and provider relationships.   Learning to Share-Sharing To Learn: How an Industry Learns to Honor it’s Volunteers Monday, June 24 This session will discuss the potential value of data sharing initiatives and what hurdles need to addressed to successfully create one. Learn what components are needed and how best to support or participate in this next step in the evolution of clinical research.   Coming Soon! Innovation Theater Schedule to be Announced - Stay Tuned!   Overview | Agenda | Register Online Keynote Speaker Preconference Tutorials Hotel & Travel Exhibiting Daniel Kraft, MD Executive Director, FutureMed Register for 2 half-day or 1 full-day tutorial, save $100 on your registration Book within the DIA Room Block, get special perks! 90% of the hall is SOLD. Reserve your booth today!

EMA head Guido Rasi to speak at EuroMeeting

§  EMA head Guido Rasi to speak at EuroMeeting

§  Guido Rasi, head of the European Medicines Agency (EMA), is just one of the A-list participants set to speak at the EuroMeeting 2013 in Amsterdam, March 4 to 6. Professor Rasi joins more than 300 speakers, moderators and panelists who substantiate the meeting’s claim to being the most important event in the medicines development calendar. Find out about all the high-profile attendees – read the press release and download the Conference Programme.     

 

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Speaker Highlights at EuroMeeting 2013 and Pre-conference tutorials

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Speaker Highlights at EuroMeeting 2013 Guido Rasi, head of the European Medicines Agency (EMA), is just one of the A-list participants set to speak at the EuroMeeting 2013 in Amesterdam March 4-6. Professor Rasi joins more than 300 speakers, moderators and panelists who substantiate the meeting’s claim to being the most important event in the medicines development calendar. He will co-chair the event’s Regulatory Town Hall Meeting on March 6 from 2pm-3:30pm, together with Christa Wirthumer-Hoche, Member of the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), and Deputy Head, Austrian Medicines and Medical Devices Agency (AGES). This session will give attendees the chance to ask burning questions to experts about a broad range of current hot topics in the development of medicines. Top Pre-conference Tutorials Pre-conference Tutorials are a very effective way of getting the most out of the EuroMeeting 2013. Register for one of 16 Pre-conference Tutorials to be held on Monday, March 4, 9am-12:30pm. Two of the most popular tutorials are outlined below: Available with new instructors! Tutorial 1: Highlights of the Implementation of the new Pharmacovigilance Legislation With Regard to Adverse Reaction Reporting Rules, use of new International Standards and Signal Management in Eudravigilance Gro Laier, Deputy QPPV, Novo Nordisk A/S, Denmark Sarah Vaughan, Pharmacovigilance Information Unit Manager, Medicines and Healthcare Products Regulatory Agency (MHRA), UK This tutorial will focus on the impact of the changes in relation to the new reporting rules and requirements as set out in the Commission’s Implementing Measures and the GVP Modules. It will also highlight the strengthening of the EudraVigilance System to improve transparency and data quality, and to support signal detection and management activities in the EU. In addition, specific emphasis will be put on informing, explaining and helping stakeholders understand how to apply the new rules, taking into account international standardization and harmonization activities and data privacy challenges. NEW! Tutorial 7: The Dialogue and Negotiation Process Between Applying Company and the Paediatric Committee of the European Medicines Agency Klaus Rose, Chief Executive Officer, KlausRose Consulting, Basel, Switzerland No new drug or biological can be submitted for marketing authorization in the EU in adults without an agreed Pediatric Investigation Plan (PIP) or a waiver from the European Medicines Agency (EMA). The development of a pediatric strategy can be divided into three phases: · Strategic preparation and homework · The dialogue and negotiation procedure with the Pediatric Committee (PDCO) of the EMA · Follow-up activities including performing agreed studies and other measures, PIP modification(s), and compliance check by EMA This tutorial will focus on the dialogue and negotiation procedure during its different stages, from the submission of the initial letter of intent to the adoption of the final PDCO position. It will present key learnings on frequently encountered difficulties or misunderstandings from EMA/PDCO and applying companies. The tutorial will be as interactive as possible and should help attendees reduce avoidable misunderstandings in the future. Download the most current version of the Conference Programme and read about all the themes, sessions, exhibition and other activities the EuroMeeting has to offer. To find out more or to register visit the EuroMeeting 2013 website.

Session Highlights at EuroMeeting2013 - 4-6 March in Amsterdam

Session Highlights at the EuroMeeting 2013 Among the packed conference programme of the EuroMeeting are a few sessions, that you definitely don't want to miss. Hot topics, presentations delivered by high level speakers, and the opportunity to discuss current issues with fellow professionals and our special presenters. Opening Plenary: Public/Private Partnerships – Working Together in the Interest of Patients 4 March | 14:00-17:15Public-private partnerships (PPP) are collaborative relationships that transcend national boundaries. Each partnership brings together at least a corporation or an industry association and intergovernmental organisations to achieve a shared health-creating goal on the basis of a mutually agreed division of tasks. The positive aspects and concerns of these initiatives will be discussed. Moderator: Steffen Thirstrup, Head of Division, Medicines Assessment and Clinical Trials, Danish Health and Medicines Authority, Denmark Panelists: Jan Geissler, Director, EUPATI, Belgium Kemal Malik, Head of Global Development, Member of the Bayer HealthCare Executive Committee and Chief Medical Officer, Bayer HealthCare Pharmaceuticals, Germany Pat O’Mahony, Chief Executive, Irish Medicines Board, Ireland Luca Pani, Director General, Italian Medicines Agency (AIFA), Italy Andrzej Rys, Director of Health Systems and Products, European Commission, EU Harpreet Singh, Managing/CSO, Immamics Biotechnologies, Germany Sessions 1803/1804: GCP Hot Topics 5 March | 14:00-17:30 Session Chairs Gabriele Schwarz, Head, GCP Inspection Services, German Federal Institute for Drugs and Medical Devices (BfArM), Germany Beat Widler, Senior Partner, Widler & Schiemann, Switzerland The GCP Hot Topics Sessions that in recent editions of the EuroMeeting have been bringing together regulators, industry, CRO and academia professionals who want to get first hand information on newest trends, has by now become a EuroMeeting tradition. In 2013 the impact of changes and evolutions in technology on the conduct and quality management of clinical trials determine the programme of the GCP Hot Topic session. The focus will be on electronic health records (EHRs) when used as source documents or direct input source into clinical trial databases. As a second topic the session will deal with the challenges presented to sponsors and CROs when clinical trial activities are outsourced. This topic is not new but becomes increasingly a root cause of major and critical inspection findings. The program will be completed by the presentation of the White Paper on protocol violations that has been authored by the GCP SIAC. As in other years the roster of international speakers will involve senior representatives from health authorities, industry and CROs. The audience is invited to actively participate in the panel discussions by bringing examples or challenging statements. Delegates can anonymously submit topic-related questions or cases they would like to be discussed by the panel in advance to the session chairs via the DIA. Session 1805: EMA Roundtable – Scientific Committees United in Diversity 6 March | 9:00-10:30 Session Chair: Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU This roundtable will discuss how the EU Scientific Committees come together and interact at the European Medicines Agency to foster scientific excellence in the evaluation and supervision of medicines for the benefit of public health, while being enriched by the EU’s many different cultures and traditions. Session 1207: Regulatory Town Hall Meeting 6 March | 14:00-15:30 Session Co-Chairs: Guido Rasi, Executive Director, European Medicines Agency, EU and Christa Wirthumer-Hoche, Member CMDh, Deputy Head, Austrian Medicines and Medical Devices Agency (AGES), Austria. At the Town Hall Meeting attendees can put burning questions to experts about these topics: • Latest views on legislative changes • Implementation of the new pharmacovigilance legislation • Transparency • Drug shortages • Decision making • New approaches to licensing Download the full Conference Programme and read about these, and the 110+ other sessions, the exhibition and other activities the EuroMeeting has to offer. If you have any specific questions, please feel free to contact us. Make the most of your EuroMeeting Experience - register for a Pre-Conference Tutorial Monday, 4 March | 09:00-12:30 Read more... Download Advance Programme Register now Exhibiting Opportunities at the 25th Annual EuroMeeting Showcase your company’s products or services to key decision makers The exhibition hall is one of the busiest places at the meeting and provides a unique opportunity to interact with professionals from more than 50 countries working in pharma, devices, government, academia, healthcare delivery and other related occupations, together with representatives from patient organisations and much more. Apply for your Exhibition space today! More information... Download Application Form.... Exhibitor Prospectus Marketing & Hosting Information

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