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?


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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?

Professional development - Tutorials at EuroMeeting2013 4 March in Amsterdam

TUTORIAL (17)

• Title: Tutorial 01: Highlights on the Implementation of the New Pharmacovigilance Legislation with regards to Adverse Reaction Reporting Rules, Use of New International Standards and Signal Management in Eudravigilance
  Event Type: TUTORIAL

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 02: Analysis of Safety Data from Clinical Trials
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 03: Update on Practical Work with Variation Regulation
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 04: Introduction to Medical Device Regulation
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 05: Recent and Current developments in Pharmaceutical Law
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 7: THE DIALOGUE AND NEGOTIATION PROCESS BETWEEN APPLYING COMPANY AND THE PAEDIATRIC COMMITTEE OF THE EUROPEAN MEDICINES AGENCY 
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 08: Health Technology Assessment of Drugs and Medical Devices
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 09: The European QP for Pharmacovigilance: Everything you ever Wanted to know but were afraid to ask
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 10: Non-Clinical Safety Assessment in Global Pharmaceutical Development 
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 11: Interactions between Regulatory and Intellectual Property, Privacy and Product Liability
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 12: Development Safety Update Report (DSUR) Kick-off in 2011: Then and Know
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 13: Technology Transfer for Biopharmaceuticals Workshop
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 14: Pharmacovigilance Audits and Inspections
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 15: Coding with Confidence
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 16: Understanding Translational Medicine: Benefits and Innovative Approaches 
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 17: Creating Compliant Clinical Study Reports for the EU and US
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Roundtable 01: GCP Inspections and Audit Findings
  Event Type: TUTORIAL

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM

Upcoming Life Sciences/Professional Development opportunites with DIA- India, Canada, Japan, and Singapore

From DIA

Upcoming DIA Meetings: INDIA Final Days to Register! DIA India 7th Annual Meeting November 1-4 | Hyderabad With 2 Tutorials: Bioinformatics and Personalized Medicine Join colleagues in new avenues in clinical operations, data management, highlighting systems biology paradigm as well as networking with the largest gathering of International and Indian Regulators and Industry professionals in India. On Twitter: #DIAIndiaAM2012 To exhibit & showcase your products and services call +91.98.1977.7493 NORTH AMERICA: DIA’s Annual Canadian Meeting: Evolutions in Risk Thinking November 6-7 | Ottawa This meeting will explore the challenges that industry, regulators, policy makers and those involved in health product lifecycle face in understanding and defining acceptable levels of risk across disciplines and through the drug development and lifecycle management. JAPAN: 9th DIA Japan Annual Meeting November 19-21 | Tokyo, Japan Patient safety will be the primary focus in this year’s meeting; our key words will be “Patient Benefit.” We will expand the scope of our meeting to cover global development with a special 3-day, 6-track workshop. 1st Clinical Operation & Monitoring Workshop in Japan January 24-25 | Tokyo, Japan This workshop is a first in clinical operations and monitoring. Better reach your colleagues and gain new perspectives on industry challenges. Don't miss interactive sessions and networking, too. Save the Date for DIA's 2013 Meetings Asia Regulatory Conference 2013 January 28-30, 2013 | Singapore This three-day conference offers a unique opportunity for key stakeholders from health authorities, local and multinational pharmaceutical companies, and clinical research to meet and exchange views, discuss topics of interest and identify focus areas for ongoing efforts to increase patient access to new and improved medicines.   16th Annual Workshop in Japan for Clinical Data Management: SMART CDM February 7-8 | Tokyo, Japan This meeting focuses on SMART CDM, to further teach all attendees, from beginners to experts, to take advantage of sophisticated technology and information, provide new perspectives on international clinical data management and create better solutions for smarter CDM, as well as opportunities to network with colleagues in global Clinical Data Management.

BIO Investor Forum – Raring to Go: The Race to Treat Ultra-Rare Diseases

from BIOtechNow by biotechnow@bio.org (Biotechnology Industry Organization)

 

The signing of FDASIA by President Obama in July reinforces the country’s commitment to fostering innovation for rare diseases. With a record 460 medicines in late-stage clinical trials, biopharmaceutical companies have embraced rare disease medicine and are rapidly developing the pipeline. In anticipation of an even more compelling opportunity, many companies are taking a step beyond and focusing on ultra rare diseases.

Last week’s 11th Annual BIO Investor Forum in San Francisco hosted a panel, Raring to Go: The Race to Treat Ultra-Rare Diseases, which provided an in-depth analysis of this thriving market opportunity by featuring companies specializing in the ultra rare disease market alongside clinical and policy / regulatory experts in the field.

Moderated by Ellen Licking, Senior Writer & Analyst, Real Endpoints, the panel opened with a focus on the legislation and the regulatory environment. Licking pointed out that there has been a recent uptick in interest on rare diseases which has led to an increase in deal-making. With the recent passage of FDASIA, there have been new opportunities identified for expediting review and approval of rare disease drugs, including accelerated approval, expanded reviewer training and priority review voucher programs to include pediatric rare diseases.

for complete article: BIO Investor Forum – Raring to Go: The Race to Treat Ultra-Rare Diseases

Discovery through Commercialization - 7th Annual Conference - Hyderabad, India

Discovery through Commercialization The 7th Annual Conference will include multiple tracks focusing upon the confluence of discovery,  development, manufacturing and commercialization towards the development of innovative, path-breaking strategies in the realm of personalised health care. Here are a few of the sessions at this year's conference. Target Discovery This session chaired by V. N. Balaji, Consultant, Discovery Research will discuss Applications of Next Generation Sequencing and Genomics—from Target Discovery to Clinical Trials and Beyond by Raja Mugasimangalam, CEO, Genotypic Technology Distilling Omics Data for Drug Discovery by Kalpana Krishnaswamy, CEO, Metaome Science Informatics Homology Modeling of Proteins and Ligand Docking: How close are we to drug discovery? by R. Sowdhamini, Associate Professor, National Centre for Biological Sciences Processes   Register Online      Read More Public Knowledge and Perceptions as Drivers or Barriers to the Future of Clinical Research in India This session chaired by Tal Burt, Scientific Director, Duke Global Proof-of-Concept (POC), Research Network will discuss PARTAKE Program and Survey of Public Knowledge and Perceptions of Clinical Research by Tal Burt, Scientific Director, Duke Global Proof-of-Concept (POC) Research Network Challenges of Drug Development in India – The Relevance of Public Awareness and Partnership by Krathish Bopanna, President and CEO, Semler Research The Role of Stakeholder Collaborations in the Ethical Conduct of Clinical Research by Nandini Kumar, Former Deputy Director General, Senior Grade Investigator NIH project, National Institute of Epidemiology   Register Online      Read More Health Economics and Valuation This session chaired by Shashidhar Rao, Head Global Medical Affairs and HEOR, India Operations, Novartis Healthcare will discuss New Molecules: Paths to their Development and Commercialization in India by Nidhi Saxena, Founder and CEO, Karmic Lifesciences Personalization and Regulatory Framework by Arun Bhatt, President, Clininvent Research Approach to Early Phase Health Economics Evaluations by Adrian McKemey, Practice Leader, Product Development & Commercialization, Quintiles   Register Online      Read More 7th Annual Conference Registration Fees Reduced Registration fees at the 7th Annual Conference have been reduced by nearly 20% to as low as Rs. 9,000 + taxes to help the industry participate in large numbers and gain immensely through this unique networking opportunity. Click here to view the conference program with over 75 International & India industry leaders. For more information and group registrations please contact Rhean.DSouza@diaindia.org or call +91.98.2058.7798. Follow us and tweet on the 7th Annual Conference with #DIAIndiaAM2012   Register Online      Read More Email Preferences    |    My DIA    |    Forward to a Friend    |

Enhance Efficiency and Decision Making During Research and Development

DIA/FDA: Revitalizing Productivity in Drug Development October 23-24 | Bethesda, MD Review the status quo of the pharmaceutical industry and explore the initiatives that champion the continued revitalization of R&D productivity in drug development. This two-day conference will provide a forum for industry, regulators, and academia to come together to discuss challenges and opportunities, share visions, experiences, and lessons learned, as well as successes and failures in the challenging journey of drug development. Hotel Discount ends October 1. Hurry, Space is Limited!   Program Overview | Register Today Stay Connected with DIA Formulate Innovative Thinking for Revitalizing R&D Productivity Keynote Speakers: Keynote Address I - Revitalizing R&D: What Could We Be Doing Differently? Robert J. Temple, MD Deputy Center Director for Clinical Science CDER, FDA Keynote Address II - An Overview of the Future for Drug Development Under the New Imperatives Delivered by Both Commercial and Regulatory Pressures Stephen A. Arlington, PhD Partner, Global Pharmaceutical and Life Sciences Advisory Services Leader PricewaterhouseCoopers LLP Keynote Address III - How Do We Revitalize R&D in New Drug Development? Frank W. Rockhold, PhD Senior Vice President, Global Clinical Safety and Pharmacovigilance GlaxoSmithKline Keynote Address IV - Collaborative Approaches to Advancing Clinical Development Charles G. Beever, MBA Vice President Booz and Company Get Perspective from these CDER, FDA Speakers: Ni Khin, MD Medical Officer, Division of Scientific Investigations Sumathi Nambiar, MD, MPH Deputy Director for Safety, Division of Anti-Infective Products Robert T. O'Neill, PhD Senior Statistical Advisor, Office of Translational Sciences H.M. James Hung, PhD Division Director, Office of Translational Science Freda W. Cooner, PhD Mathematical Statistician, Office of Translational Science Rajeshwari Sridhara, PhD Director, Division of Biometric V, OB/OTS Geoffrey Kim Medical Officer, Division of Oncology Products Office of Hematology and Oncology Leslie Ball, MD Acting Director, Office of Scientific Investigations Shakuntala M. Malik, MD Medical Office, Division Office of Hematology Oncology Drug products (OHOP) Peiling Yang, PhD Math Statistician Team Lead, OTS Sue-Jane Wang, PhD, MA, MS Associate Director, Adaptive Design and Pharmacogenomics, OB, OTS In collaboration with

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