Life Science Items of Interest: HTA

Showing posts with label HTA. Show all posts

Wednesday, September 25, 2013

第10回DIA 日本年会では

第10回 DIA日本年会　日本発の創薬革命～革新的創薬・育薬に向けたアカデミア・行政・企業の果たすべき役割～【日時】2013年11月6日（水）～8日（金）【場所】TFT東京ファッションタウンビル（有明）

DIA日本年会は、医薬品を始めとする医療用製品の開発やライフサイクルマネジメントに関するグローバルな最新のトピックを取り上げ、国内外の企業・アカデミア・規制当局が一堂に会し、オープンに意見交換・議論を行うする国内最大規模の会議です。

第10回DIA 日本年会では、委員長に千葉大学学長　齋藤康先生をお迎えし、「日本発の創薬革命～革新的創薬・育薬に向けたアカデミア・行政・企業の果たすべき役割～」をテーマに、創薬・育薬に果たす企業・アカデミア・行政の役割をさまざまな角度から議論します。プログラムは3日間６トラックで進行し、薬事、臨床開発、安全性、統計・DM、PM、CMC、シックスシグマ、HTA、患者会などの領域に関連した数多くのセッションが企画されています。

http://www.diajapan.org/meetings/13303/

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Monday, April 22, 2013

How are comparative effectiveness research and HTA applicable to the biopharmaceutical industry?

Understanding Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA) inthe Biopharmaceutical Industry

June 23 from 1:00PM – 4:30PM in Boston

Health care reform has amplified interest in Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA). CER/HTA may sound threatening without a realistic context for what it is, how it has evolved, what it is intended to do and its limitations. A brief introduction and overview of CER/HTA will be presented through lecture, interactive discussions and case study. This tutorial will present a perspective of CER/HTA in the context of clinical trials and health care policy and provide timely insights for today’s biopharmaceutical professionals.

Instructor(s):
Nancie E. Celini, DrPH,MPH
Chief Learning Consultant
CAB Inc., United States

Vadim Tantsyura, DrPH,MA,MS
Director, Data Management
Cincinnati Children's Hospital Medical Center, United States

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

Thursday, April 18, 2013

Speak at the EuroMeeting 2014

26th Annual EuroMeeting 2014
March 25-27 | Vienna, Austria
Abstract submission deadline: May 29

Submit your presentation, session or tutorial abstracts for DIA’s Annual EuroMeeting and share your research with more than 3,000 professionals from around the world.

Session Abstract
A session abstract is a 90-minute session concept delivered lecture-style from the podium. The abstract author is considered the session chair and will coordinate efforts in recruiting speakers and manage the session. PowerPoint presentations are required. We welcome innovative ideas for session formats that will enhance interaction between stakeholders.

Presentation Abstract
A presentation abstract is for a 20-minute presentation in a specific topic area. The abstract author is considered the speaker and a PowerPoint presentation is required.

Tutorial Abstract
A tutorial is a ‘hands-on’, interactive learning experience. A tutorial consists of three hours of instruction with a 30-minute break halfway through. The abstract author is considered the instructor. One co-instructor may be recruited but cannot be from the same company/organization as the author.

To give your session, presentation or tutorial abstract the best chance of being accepted focus on the programme themes.

Hot-Topic/Stand-Alone Sessions
Each year, there are a number of sessions that do not fit directly under the programme themes. If your abstract clearly does not fit with any of the themes/topics outlined, you may submit it for consideration as a hot-topic/stand-alone presentation/session.

Find Out More | Submit Your Abstract

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Monday, April 8, 2013

Health Economic Outcomes/Comparative Effectiveness Research/Health Technology Assessment Track at DIA's 49th Annual Meeting

TRACK 13: HEALTH ECONOMICS AND OUTCOMES (HEO)/COMPARATIVE EFFECTIVENESS RESEARCH (CER)/HEALTH TECHNOLOGY ASSESSMENT (HTA)
Learning Objectives: Describe current issues in measuring and communicating the medical need, health impact, and economic value associated with medical products

How can clinical trial design impact reimbursement potential?

How are comparative effectiveness research and HTA applicable to the biopharmaceutical industry?

What are the pharma, safety, and patient perspectives on big data methodology?

2012 US Payer Landscape survey looks at CER and EBM use in coverage decision making.

What are benefits and outcomes of collaborations between payers and pharmaceutical companies?

How can we utilize EMRs as an innovative methodology for evaluating Therapeutic Effectiveness?

What are different ways for incorporating patient-centered approaches in model development?

What are pros/cons of using observational methods to support comparative effectiveness research?

How can information sharing be facilitated across Sponsors, Regulatory and HTA Agencies?

How do Public and Private Payers translate CER into Medical Payment Policy?

Saturday, April 6, 2013

Project/Portfolio Management Track at DIA's 49th Annual Meeting

Tuesday, March 5, 2013

What's on tap for final day of EuroMeeting2013? March 6, Amsterdam

EuroMeeting2013
RAI
Amsterdam

Title: FOCUS ON MANAGED ENTRY AGREEMENTS (AND REAL WORLD DATA)
Event Type: SESSION
Tracks: Theme 01 - HTA/Sustainability of Health Systems in Europe Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM
Title: HOW TO OPTIMISE CLINICAL DEVELOPMENT IN THE ELDERLY: SOME PRACTICAL EXAMPLES
Event Type: SESSION
Tracks: Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM
Title: FROM VOLUNTARY HARMONISATION TO CLINICAL TRIAL REGULATION L TRIALS
Event Type: SESSION
Tracks: Theme 03 - Legal/Transparency-Risk Assessment Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM
Title: NEW OPPORTUNITIES FOR INFORMATION TECHNOLOGY IN PHARMACOVIGILANCE
Event Type: SESSION
Tracks: Theme 04 - Pharmacovigilance Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM
Title: QUALITY UPDATE - CURRENT DEVELOPMENTS
Event Type: SESSION
Tracks: Theme 06 - Quality (including Falsified Medicines) Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM
Title: LATEST US REGULATORY MOVES TOWARDS FOSTERING INNOVATION: UPDATE ON MAIN NEW AND REVISED REGULATIONS AND GUIDANCE
Event Type: SESSION
Tracks: Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM
Title: KNOWN ACTIVE SUBSTANCES FOR THE SELF-CARE SECTOR
Event Type: SESSION
Tracks: Theme 10 - Known Active Substances Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM
Title: INNOVATIVE APPROACHES TO PRODUCT INFORMATION FOR PHYSICIANS AND PATIENTS
Event Type: SESSION
Tracks: Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work? Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM
Title: MNC’S EXPANSION IN EMERGING MARKETS: OPPORTUNITIES AND CHALLENGES
Event Type: SESSION
Tracks: Theme 13 - Globalisation Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM
Title: A CASE STUDY USING THE FRAMEWORK SUPPORTED BY QUANTATATIVE METHODS FOR BENEFIT/RISK ASSESSMENT
Event Type: SESSION
Tracks: Theme 15 - Growing Demand for Quantitative Approaches in Drug Development Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM
Title: NON-CLINICAL TESTING FOR ADVANCED THERAPY
Event Type: SESSION
Tracks: Theme 16 - Non-Clinical Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM
Title: FOCUS ON MEDICINES EFFICACY, SAFETY AND USAGE IN EDUCATION AND TRAINING
Event Type: SESSION
Tracks: Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM
Title: EMA ROUNDTABLE- SCIENTIFIC COMMITTEES UNITED IN DIVERSITY
Event Type: SESSION
Tracks: Theme 18 - Stand-Alone Sessions Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM
Title: SOCIAL MEDIA/USE OF TABLETS AND SMARTPHONES
Event Type: SESSION
Tracks: Theme 08 - eTools and Data Management Day: Wednesday, Mar, 06
Time: 9:00AM - 10:30AM
Title: THE IMPACT OF THE NEW PHARMACOVIGILANCE LEGISLATION INSTRUMENTS ON HTAS
Event Type: SESSION
Tracks: Theme 01 - HTA/Sustainability of Health Systems in Europe Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM
Title: PAEDIATRIC CLINICAL TRIALS – TRIAL BY DESIGN
Event Type: SESSION
Tracks: Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM
Title: TRANSPARENCY ON DOSSIER AND DECISION MAKING – HAS PUBLIC TRUST INCREASED?
Event Type: SESSION
Tracks: Theme 03 - Legal/Transparency-Risk Assessment Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM
Title: RISK COMMUNICATION AND TRANSPARENCY
Event Type: SESSION
Tracks: Theme 04 - Pharmacovigilance Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM
Title: ADOPTION OF GAME CHANGING TECHNOLOGIES
Event Type: SESSION
Tracks: Theme 05 - Clinical Research and Development Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM
Title: INTERNATIONAL HARMONISATION: GLOBAL REGULATORS’ PROGRESS FROM GHTF TO IMDRF - ARE WE ANY NEARER TO REGULATORY CONVERGENCE?
Event Type: SESSION
Tracks: Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM
Title: ATTRIBUTING SAFETY REPORTS TO MEDICINAL PRODUCTS
Event Type: SESSION
Tracks: Theme 08 - eTools and Data Management Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM
Title: BIOSIMILARS: DEVELOPING A MORE THOROUGH UNDERSTANDING OF A KNOWN ACTIVE SUBSTANCE
Event Type: SESSION
Tracks: Theme 10 - Known Active Substances Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM
Title: ENVIRONMENTAL CONSIDERATIONS IN PRODUCTION OF MEDICINAL PRODUCTS
Event Type: SESSION
Tracks: Theme 13 - Globalisation Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM
Title: EQUIVALENCE OF ORALLY INHALED PRODUCTS
Event Type: SESSION
Tracks: Theme 15 - Growing Demand for Quantitative Approaches in Drug Development Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM
Title: NEW TRENDS IN INVITRO NON-CLINICAL TESTING
Event Type: SESSION
Tracks: Theme 16 - Non-Clinical Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM
Title: QUALITY CAREER DEVELOPMENT IN GLOBAL MEDICINES DEVELOPMENT
Event Type: SESSION
Tracks: Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM
Title: JAPANESE REGULATORY SESSION – PMDA UPDATE
Event Type: SESSION
Tracks: Theme 18 - Stand-Alone Sessions Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM
Title: QUALITY RISK MANAGEMENT WORKSHOP
Event Type: WORKSHOP
Tracks: Theme 18 - Stand-Alone Sessions Day: Wednesday, Mar, 06
Time: 11:00AM - 12:30PM
Title: THE PATIENTS’ PERSPECTIVE ON HTA
Event Type: SESSION
Tracks: Theme 01 - HTA/Sustainability of Health Systems in Europe Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM
Title: LEGAL AND PRACTICAL ASPECTS OF OFF-LABEL USE
Event Type: SESSION
Tracks: Theme 03 - Legal/Transparency-Risk Assessment Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM
Title: IMPACT OF ICH E2C (R2) AND GVP MODULE VII
Event Type: SESSION
Tracks: Theme 04 - Pharmacovigilance Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM
Title: PATIENT RECRUITMENT AND RETENTION
Event Type: SESSION
Tracks: Theme 05 - Clinical Research and Development Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM
Title: PHARMACOPOEIAL HARMONISATION- A NEVER ENDING STORY
Event Type: SESSION
Tracks: Theme 06 - Quality (including Falsified Medicines) Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM
Title: HOW SYNERGY BETWEEN DATA MANAGEMENT AND TECHNOLOGY WILL DRIVE CLINICAL DEVELOPMENT IN THE NEXT DECADE
Event Type: SESSION
Tracks: Theme 08 - eTools and Data Management Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM
Title: COMBINATION MEDICINAL DRUG PRODUCTS OF KNOWN ACTIVE SUBSTANCES
Event Type: SESSION
Tracks: Theme 10 - Known Active Substances Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM
Title: REGULATORY TOWN HALL MEETING
Event Type: SESSION
Tracks: Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work? Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM
Title: SUBGROUP ANALYSES
Event Type: SESSION
Tracks: Theme 15 - Growing Demand for Quantitative Approaches in Drug Development Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM
Title: NEW ICH INITIATIVES IN SAFETY TESTING
Event Type: SESSION
Tracks: Theme 16 - Non-Clinical Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM
Title: EUPATI - THE EUROPEAN PATIENTS ACADEMY ON THERAPEUTIC INNOVATION – AN UNPRECEDENTED PUBLIC PRIVATE PARTNERSHIP TO EMPOWER PATIENTS TO ENGAGE AS REAL PARTNERS IN THE DRUG DEVELOPMENT PROCESS
Event Type: SESSION
Tracks: Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM
Title: ASIAN STRATEGY OF THE USA, EUROPE AND JAPAN
Event Type: SESSION
Tracks: Theme 13 - Globalisation Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM
Title: PERSPECTIVES AND COLLABORATION BETWEEN PATIENTS AND STUDENTS
Event Type: SESSION
Tracks: Theme 18 - Stand-Alone Sessions Day: Wednesday, Mar, 06
Time: 2:00PM - 3:30PM
Title: HTA AND OFF-LABEL USE
Event Type: SESSION
Tracks: Theme 01 - HTA/Sustainability of Health Systems in Europe Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM
Title: PAEDIATRIC REQUIREMENTS – DO THEY DELIVER AND AT WHICH COST?
Event Type: SESSION
Tracks: Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM
Title: DEVELOPMENT OF PHARMACOVIGILANCE METHODOLOGY
Event Type: SESSION
Tracks: Theme 04 - Pharmacovigilance Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM
Title: COLLECTING RELEVANT HEALTH OUTCOME DATA
Event Type: SESSION
Tracks: Theme 05 - Clinical Research and Development Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM
Title: HARMONISATION – PITFALLS AND HOW CAN WE SPEED IT UP?
Event Type: SESSION
Tracks: Theme 06 - Quality (including Falsified Medicines) Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM
Title: WHICH EU REGULATORY RULES FOR TELEMEDICINE, EHEALTH AND MHEALTH? HOW CAN INNOVATION BE ENCOURAGED?
Event Type: SESSION
Tracks: Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM
Title: CLINICAL TRIALS IN EUROPE: WILL THE REVISED LEGISLATION MEET THE DEMANDS OF TOMORROW?
Event Type: SESSION
Tracks: Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work? Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM
Title: STATISTICAL HOT TOPICS IN SCIENTIFIC ADVICE
Event Type: SESSION
Tracks: Theme 15 - Growing Demand for Quantitative Approaches in Drug Development Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM
Title: OVERVIEW OF CURRENT DISCUSSIONS IN ICH
Event Type: SESSION
Tracks: Theme 16 - Non-Clinical Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM
Title: TOWARDS A EUROPEAN FRAMEWORK FOR CONTINUING PROFESSIONAL DEVELOPMENT IN A LIFE-LONG LEARNING PERSPECTIVE
Event Type: SESSION
Tracks: Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients Day: Wednesday, Mar, 06
Time: 4:00PM - 5:30PM

Life Science Items of Interest