How does the Japanese regulatory system impact on local and global drug development strategies?

Japan's Regulatory Environment: Overview of the Organization, Processes, Systems and Changes Affecting Pharmaceutical Development:
June 23 from 8:30AM – 12:00PM in Boston

This tutorial is designed for professionals in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan. Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This tutorial will describe the major drivers of the regulatory system, including the PMDA and Ministry of Health, MHLW, regulatory procedures during drug development, the integration of Japan drug development with East Asian and global drug development, orphan drug regulation and J-NDA preparation and review.

Instructor:
Alberto Grignolo, PhD
Corporate Vice President, Global Strategy and Services
PAREXEL Consulting, 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.

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.

Global Regulatory Track at DIA's 49th Annual Meeting

CBER Town Hall: Ongoing initiatives, guidances, and regulations

CDER Town Hall: Hot topics in drug development and regulation (part 1)/(part 2)

PMDA Town Hall: Japanese regulation activities and initiatives

What are areas of convergence in regulatory science between CDE-China and CDE-Taiwan?

What is the current regulatory system and government R&D program?

European Town Hall: Implementation of New Safety Legislation

What do stakeholders need to know about the Canada-US #RCC?

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

What are Canadian approaches to Regulatory Modernization and Int'l Engagement?

Latin America Town Hall: How are LA regulations modeled after and differ from EMA and FDA regulations?

7th Annual Workshop in Japan for Asian New Drug Development ~Register by April 1 to Save

Limited seating available 7th Annual Conference for Asian New Drug Development in Japan – last chance to register. Day 1 Highlights The conference, to be held at Nakano Sunplaza in Tokyo from April 15-16, will provide a forum for exchange of opinions among the regulatory agencies in East Asia, including the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, the Korea Food and Drug Administration (KFDA) and the Center for Drug Evaluation (CDE) in Taiwan. Constructive discussions will be held on how to overcome the hurdles still remaining in new drug development using case studies of drugs that obtained approvals in Japan based upon East Asia multiregional clinical trial (MRCT) data. Day 2 Highlights Day two of the conference starts with a session that will discuss one of the key factors influencing development strategy –Market Access. The attendees will particularly focus on differences in practice among countries. An interactive workshop will follow, lead by instructors who have day-to-day experience in new drug development in East Asia. The workshop will be valuable to participants who are planning to file IND/NDA in China, Korea, and Taiwan, who are interested in regulations and clinical development operations in East Asia, or who are working on the front line of clinical development. Overview Download Program Register Online Upcoming events Register online or download an application form and forward to: DIA Japan, Nisso 22 Building, 7F, 1-11-10 Azabudai, Minato-ku, Tokyo 106-0041 Japan Tel: +81-3-5575-2130 Fax: +81-3-3583-1200 DIAJapan@diajapan.org Tabletop exhibit opportunity Please contact DIA Japan for details about tabletop exhibits. Tel: +81-3-5575-2130 Fax: +81-3-3583-1200 Email: DIAJapan@diajapan.org Overview Download Program Register Online

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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