For our friends in China, we kindly suggest the following sessions at #DIA2013 in Boston, MA.

For our friends in China, we kindly suggest the following sessions at this year's annual meeting in Boston, MA.

Global Clinical Trials: The Role of Emerging Markets         
What are the areas of potential risks when undertaking global clinical trials in emerging markets?
Convergence in Regulatory Science Across the Strait
What are areas of convergence in regulatory science between CDE-China and CDE-Taiwan?
GCPs in Emerging Countries
What are the GCP quality trends in US and emerging countries?
Pharmacovigilance Update for Japan, Developing Asia and Latin America
What are latest developments in pharmacovigilance in the developing countries of Asia and Latin America?
A Regulatory Perspective of Biosimilars in Emerging Markets
What are similarities/differences in biosimilar regulatory requirements in APAC and Latin America?

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

For our friends in India, we kindly suggest the following sessions at #DIA2013 in Boston, MA.

For our friends in India, we kindly suggest the following sessions at this year's annual meeting in Boston, MA.

Global Clinical Trials: The Role of Emerging Markets         

What are the areas of potential risks when undertaking global clinical trials in emerging markets?

GCPs in Emerging Countries

What are the GCP quality trends in US and emerging countries?
Partnering and Outsourcing Challenges in India: The New Paradigm Shifts
Partnering and #outsourcing in India: Strategies for integrating diverse skills around operational deliverables.
A Regulatory Perspective of Biosimilars in Emerging Markets
What are similarities/differences in biosimilar regulatory requirements in APAC and Latin America?


Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

For our friends in Japan, we kindly suggest the following sessions at #DIA2013 in Boston, MA.

 

For our friends in Japan, we kindly suggest the following sessions at this year's annual meeting in Boston, MA.

Global Clinical Trials: The Role of Emerging Markets         

What are the areas of potential risks when undertaking global clinical trials in emerging markets?
GCPs in Emerging Countries
What are the GCP quality trends in US and emerging countries?

Risk Management in the US, EU and Japan: The Challenges of Diversity

What are differences in legislation for risk management between the US, EU and Japan?
Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall
PMDA Town Hall: Japanese regulation activities and initiatives

Challenges for Stable Supply of Drugs and International Cooperation

What is the current drug supply situation in US, EU and Japan?

Pharmacovigilance Update for Japan, Developing Asia and Latin America

What are latest developments in pharmacovigilance in the developing countries of Asia and Latin America?

A Regulatory Perspective of Biosimilars in Emerging Markets

What are similarities/differences in Biosimilar regulatory requirements in APAC and Latin America?


Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

Clinical Operations Track at DIA's 49th Annual Meeting

 

• What are the emerging challenges with patient registries? 
• What do you need to know about statistics?  Variability~confidence intervals~hypothesis testing~p-values
• What are the best practices in patient recruitment, budgets and contracts, and FDA audit readiness?
• How do you ensure data integrity with reduced expenditures on traditional 100% on-site monitoring and SDV?
• How do different enrollment metrics/analyses benefit different stakeholders (site/sponsor/recruiter)? 
• Do you know how to shape your cost with hard and soft coverage analysis trends?
• How can investigator sites pave the way for running successful Clinical Trials?
• Is this trial worth it? Finding answers for Site and Project Managers.
• How should you tailor existing patient recruitment programs to engage parents for Pediatric Trials?  
• How do you establish metrics for Optimal Patient Recruitment and Retention?  
• What global requirements are needed in the Informed Consent Process? 
• What are the Domestic and Global trends in Clinical Trial budgeting?  
• How can we use Big Data to design smarter clinical studies? 
• Can a mathematical algorithm used in point-of-care risk assessment id and screen Clinical Trial subjects?  
• How do you build Patient engagement to make Clinical Research better for everyone?  
• Learn to apply innovation, avoid controversy and implement best practices in Clinical Trials 
• How can site metrics be used to improve enrollment timelines?
• Can you identify Pharmacy-directed outreach and Patient  Recruitment strategies for your Clinical Trial? 
• What do you need to maintain regulatory compliance with continuously evolving import/export processes? 
• How do you solve key challenges to running efficient investigator meetings during Clinical Study startup? 
• What impact will FDASIA have on your need to recruit diverse clinical subjects?  
• What 4 pillars support comprehensive operational feasibility assessment for Clinical Trial planning?  
• Fed Up with tracking pointless Metrics? Learn how to select and use Metrics that work.  
• What are the challenges and requirements of implementing Central Statistical Monitoring? 
• What unique challenges are associated with pediatric trial recruitment, retention and blood sample collection?  
• What are the Diverse Operational Approaches to generating evidence in the Late-phase Environment? 
• What are the areas of potential risks when undertaking Global Clinical Trials in Emerging Markets? 

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

EuroMeeting2013
RAI
Amsterdam

Final day: Wednesday, Mar, 06 (51)

• 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