Pre-conference Tutorials - Monday, 4 March 2013 Amsterdam

View in Programme [PDF]

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

Tutorial 2 - Analysis of Safety Data from Clinical Trials

Tutorial 3 - Update on Practical Work with Variations Under the Revised Regulation

Tutorial 4 - Introduction to EU Mecical Device Regulation

Tutorial 5 - Recent and Current Developments in Pharmaceutical Law

Tutorial 6 - CANCELLED - Incentives for Drug Development
NEW!Tutorial 7 - The Dialogue and Negotiation Process Between Applying Company and the Paediatric Committee of the European Medicines Agency

Tutorial 8 - Health Technology Assessment (HTA) of Drugs and Medical Devices

Tutorial 9 - The European Qualified Person for Pharmacovigilance; Everything you ever wanted to know but were afraid to ask

Tutorial 10 - Non-Clinical Safety Assessment in Global Pharmaceutical Development

Tutorial 11 - Interactions Between Regulatory and Intellectual Property, Privacy and Product Liability

Tutorial 12 - Development Safety Update Report (DSUR) Kick-Off in 2011 - And now in practice

Tutorial 13 - Technology Transfer for Biopharmaceuticals

Tutorial 14 - Pharmacovigilance Audits and Inspections

Tutorial 15 - Coding with Confidence

Tutorial 16 - Understanding Translational Medicine

Tutorial 17 - Creating Compliant Clinical Study Reports (CSRS) for the EU and US

Tutorial 18 - Roundtable Discussion (Special Fee €200 + VAT): GCP Inspection and Audit Findings

HTA/Sustainability of Health Systems in Europe sessons at EuroMeeting2013 - 4-6 March in Amsterdam

Theme 01 - HTA/Sustainability of Health Systems in Europe (7)

• Title: THE EUROPEAN LANDSCAPE ON HTA - THE EUnetHTA JOINT ACTION
  Event Type: SESSIONDay: Tuesday, Mar, 05
  Time: 11:00AM - 12:30PM
• Title: COMPARATIVE EFFECTIVENESS AS PART OF THE PUBLIC ASSESSMENT REPORT (PAR)
  Event Type: SESSIONDay: Tuesday, Mar, 05
  Time: 2:00PM - 3:30PM
• Title: HTA AND PRICING POLICIES IN EU AFTER THE TRANSPARENCY DIRECTIVE
  Event Type: SESSIONDay: Tuesday, Mar, 05
  Time: 4:00PM - 5:30PM
• Title: FOCUS ON MANAGED ENTRY AGREEMENTS (AND REAL WORLD DATA)
  Event Type: SESSIONDay: Wednesday, Mar, 06
  Time: 9:00AM - 10:30AM
• Title: THE IMPACT OF THE NEW PHARMACOVIGILANCE LEGISLATION INSTRUMENTS ON HTAS
  Event Type: SESSIONDay: Wednesday, Mar, 06
  Time: 11:00AM - 12:30PM
• Title: THE PATIENTS’ PERSPECTIVE ON HTA
  Event Type: SESSIONDay: Wednesday, Mar, 06
  Time: 2:00PM - 3:30PM
• Title: HTA AND OFF-LABEL USE
  Event Type: SESSIONDay: Wednesday, Mar, 06
  Time: 4:00PM - 5:30PM

25th Annual EuroMeeting - 4-6 March 2013 - Amsterdam

Welcome from the EuroMeeting Co-Chairs

Dear Colleague,

We are delighted to welcome you to the 25th DIA Annual EuroMeeting to be held in Amsterdam, 4-6 March 2013. Amsterdam is the ultimate “small big city” and combines all the advantages of a cosmopolitan capital with a compact, easy-to-navigate size which translates in less time spent in commuting and more time enjoying what the city has to offer.

The city has a rich cultural heritage and 2013 is a year to celebrate important events there. Besides the 400-year anniversary of the Canal Ring, Amsterdam will be celebrating the re-opening of the fully renovated Rijksmuseum, the 125th anniversary of the Concertgebouw (concert hall) and the Royal Concertgebouw Orchestra, the 225th anniversary of Felix Meritis conference and event centre, and the 175th anniversary of Artis Royal Zoo.

With a focus on better public health protection, greater transparency of the processes and the rational use of medicinal products, the proposed areas for discussion for the Euromeeting 2013 are classified into general disciplines including Pharmacovigilance and Regulatory Affairs for medicinal products and medical devices, R&D and Clinical Trials. The scope of the presentations will cover the experience gathered after the implementation of the new Pharmacovigilance legislative framework, as well as from the patients’ and Health Technology Assessment (HTA) perspective. Experts and authorities in the fields will be presenting their considerations for debate.

By 2013, the new Pharmacovigilance Directive will have been in place for almost a year; knowing what still needs to be done - or improved, and most importantly: are we getting what was initially expected? These are some of the key areas that the professionals attending the meeting will be able to learn about and debate. Other important topics to be covered include the Falsified Medicines Directive, the Information to Patients – what is the status? - the role played by scientific societies as experts, and considerations over an ageing population and the potential impact on hospitalisations.

With such an appealing outline of topics, we look forward to fruitful and engaging discussions that serve to improve further our healthcare systems. Join us in Amsterdam, bring your ideas and simply: Enjoy!

Beatriz Vicén Banzo and Peter Bachman

About the EuroMeeting

The DIA’s Annual EuroMeeting is global in scope and attracts well over 3,000 professionals from more than 50 countries. It brings together professionals from the biopharmaceutical industry, contract research and service organisations, academic research centres, regulatory agencies and health ministries as well as delegates from patient organisations. This convergence affords participants the opportunity to network with professional colleagues from around the world.

Highlights

• Speakers from the European Medicines Agency, the European Commission, the FDA and other regulatory agencies from European countries and other regions of the world
• Unparalleled multi-disciplinary networking opportunities
• Student and professional poster sessions
• Active involvement of patient organisations
• Pre-conference tutorials led by expert faculty
• Hot topic sessions
• More than 200 exhibitors on one of the largest exhibition floors in Europe

Meeting Programme

Stakeholders and professionals of healthcare and life sciences innovation will gather from all over the world for the EuroMeeting 2013. You will experience a neutral, global forum for knowledge exchange that fosters innovation to raise the level of health and wellbeing worldwide. It is our vision that the EuroMeeting 2013 offers you a multidisciplinary, relevant and unforgettable learning experience and expands your personal and professional network.

With a focus on better public health protection, greater transparency of the processes and the rational use of medicinal products, the proposed areas for discussion for the Euromeeting 2013 are classified into general disciplines including Pharmacovigilance and Regulatory Affairs for medicinal products and medical devices, R&D and Clinical Trials. The scope of the presentations will cover the experience gathered after the implementation of the new Pharmacovigilance legislative framework, as well as from the patients’ and Health Technology Assessment (HTA) perspective. Experts and authorities in the fields will be presenting their considerations for debate.

The EuroMeeting 2013 transcends borders and boosts international relations by drawing attention to contemporary issues outside Europe such as in the USA, Brazil, China, Japan and India; and focusing on contemporary issues in the interface between those countries and Europe.

Download the Advance Programme [PDF]