Pre-Conference Tutorials, Monday, March 8, 2010, 09:00
Pre-Conference Tutorials, Monday, March 8, 2010, 09:00
Pre-Conference Tutorials, Monday, March 8, 2010, 09:00
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This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.<br />
<strong>Pre</strong>-<strong>Conference</strong> <strong>Tutorials</strong>, <strong>Monday</strong>, <strong>March</strong> 8, <strong>2010</strong>, <strong>09</strong>:<strong>00</strong> - 12:30<br />
TUTORIAL 20<br />
eCTD SUBMISSION COMPILATIONS FOR THE EU<br />
Olaf Schoepke, Managing Director, Extedo Ltd. UK<br />
This tutorial will guide the participants through the process of creating and<br />
validating eCTD submissions for the EU. The process will focus on regional<br />
requirements and correlations between the different procedures. Relevant<br />
guidelines will be addressed and methods discussed preparing participants for<br />
successful eCTD submissions.<br />
Learning Objectives<br />
At the conclusion of this tutorial, attendees will be able to answer the following<br />
questions:<br />
• What are the basic requirements of eCTD submissions in Europe?<br />
• How do I handle the different procedures in Europe?<br />
• What approach to filing electronically can I recommend?<br />
• How can I build and validate a compliant eCTD?<br />
• What are common pitfalls during eCTD assembly?<br />
Target Audience<br />
Regulatory; IT; document management; medical writer; publisher: submission<br />
manager<br />
TUTORIAL 21<br />
HEALTH TECHNOLOGY ASSESSMENT: EVERYTHING YOU EVER WANTED TO<br />
KNOW BUT WERE TOO AFRAID TO ASK!<br />
Kym Alnwick, HTA Technical Lead, Heron Evidence Development, UK<br />
Using practical examples, this tutorial aims to provide a contextual overview of<br />
the basic concepts involved in global health technology assessment. An<br />
introductory description of the stakeholders, methods, and debates in the field<br />
will be provided. Participants will learn how the various components of HTA<br />
require expertise from various disciplines including clinical evidence review and<br />
synthesis, economic modelling, and medical writing.<br />
Learning Objectives<br />
At the conclusion of this tutorial, attendees will be able to:<br />
• Identify the key components of HTA<br />
• Describe the development and global context of HTA, including HTA as a ‘4th<br />
hurdle’ requirement<br />
• List the aims of HTA agencies and other stakeholders; describe how HTA<br />
guidance is used and list categories of guidance<br />
Accreditation and Credit Designation<br />
• Define the main methodological terms used in HTA<br />
• Compare and distinguish the requirements of 3/4 major HTA agencies<br />
Target Audience<br />
This tutorial is intended for those with an interest in global developments in the<br />
pharmaco-economic appraisal of new health technologies, including<br />
professionals in regulatory affairs, corporate or government affairs, and health<br />
policy, as well as academics and clinicians. In addition this tutorial will be<br />
relevant to those interested in understanding the place of comparative<br />
effectiveness research (CER) relative to HTA.<br />
The Drug Information Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical<br />
education for physicians.<br />
The American Medical Association has determined that physicians not licensed in the US who participate in this CME activity are eligible for AMA PRA category 1<br />
credit.<br />
Select sessions may offer AMA RA Category 1 Credits and will be clearly identified in the final programme.<br />
The Drug Information Association (DIA) has been approved as an “Authorized Provider” by the International Association for Continuing Education and Training<br />
(IACET), 8405 Greensboro Drive, Suite 8<strong>00</strong>, McLean, VA 22102.<br />
The DIA is authorised by IACET to offer 1.5 CEUs for this programme.<br />
Best-in-Class Content,<br />
First-Rate Instructors<br />
First-rate instructors and best-in-class content are what make DIA’s training<br />
programmes the highest quality training programmes available anywhere.<br />
DIA offers a variety of courses in regulatory affairs, clinical research,<br />
non-clinical sciences and safety and pharmacovigilance. Benefits include:<br />
• Continuing education credits<br />
• Up-to-the-minute coverage of important industry hot topics<br />
• Expert faculty actively practicing in their particular discipline<br />
• Networking opportunities<br />
• Consistent course materials from one offering to another<br />
• Expert training from faculty who are professionals in the pharmaceutical<br />
and related industries<br />
• Limited attendance allows for a more personal quality learning<br />
experience<br />
• Tailor-made case studies and instructor-led group work<br />
• In-depth discussion of specific contemporary issues<br />
For more information and a complete listing of all training courses, please<br />
visit www.diahome.org and click on educational offerings.<br />
If you would like to receive a statement of credit, you must attend the programme, return your evaluation form and complete the online credit request process<br />
through My Transcript at www.diahome.org. Participants will be able to download a statement of credit upon successful submission of the credit request.
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