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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heme 11 Theme 12 Theme 13<br />
Health<br />
sion 1101<br />
Architecture for<br />
e Challenges of<br />
Health<br />
sion 1102<br />
Clinician Reported<br />
e in Global Medical<br />
lopment: An update<br />
best practice and<br />
atory issues<br />
sion 1103<br />
ase Studies<br />
sion 1104<br />
Technologies for<br />
tion of Patient<br />
eatment<br />
sion 1105<br />
rug Safety through<br />
ew Technologies<br />
sion 1106<br />
Interoperability<br />
andards<br />
sion 1107<br />
Electronic Medical<br />
linical Development<br />
sion 1108<br />
g Healthcare and<br />
al Research<br />
Pharmaceutical Sciences in<br />
2020<br />
Session 1202<br />
What Major Research Activities<br />
Will Drive Drug Discovery and<br />
Development?<br />
Session 1203<br />
What Will the Enabling<br />
Technologies Be?<br />
Session 1204<br />
What Paradigm/Geographical<br />
Shifts Will There Be in Drug<br />
Discovery/Development?<br />
Session 1205<br />
How Will Regulators and the HTA<br />
Community Reconcile the Need<br />
for Rapid Market Access with the<br />
Assessment of Benefit/Risk?<br />
Session 1206<br />
How Will Changes in Education<br />
Meet the Demands of Industry<br />
and Regulation?<br />
Clinical Trials and eSubmission Hot Topics<br />
Stand Alone Sessions<br />
Session 1302<br />
Is the European Approach to<br />
Implementation of the ICH-GCP<br />
Standard Killing Clinical<br />
Research?<br />
Session 1401<br />
Consequences of Sector Inquiry -<br />
Underestimated by the Business?<br />
Session 1402<br />
Regulatory Perspectives on<br />
Combination Products in the EU<br />
and US<br />
Session 1303<br />
Session 1403<br />
Simplification of EU Clinical Trials Practical Experiences with<br />
Framework: A Possibility? Borderline Combination Products<br />
Session 1304<br />
eCTD – Continuing<br />
Implementation – Factors<br />
affecting<br />
Session 1305<br />
Transparency from Clinical Trials-<br />
Are we patient focused?<br />
Session 1306<br />
e-Submissions in MRP/DCP and<br />
National Procedures<br />
Session 1307<br />
Exploratory Clinical Trials in the<br />
EU<br />
Session 1308<br />
Managing the End-of-Patent for<br />
a Medicinal Product<br />
Session 1404<br />
European Medicines Agency<br />
Road Maps<br />
Session 1405<br />
Regulatory IT Strategies &<br />
Standards Bodies- is there a<br />
coalescence? What should we<br />
read between the lines?<br />
Session 1406<br />
Meta-analysis for Safety<br />
Assessment - Current trends and<br />
guidances<br />
Session 1407<br />
How to Ensure Therapeutic<br />
Equivalence with Sufficient<br />
Confidence?<br />
Session 1408<br />
Drawing the Borderline between<br />
Medicines and Other Categories<br />
of Self-Care Products: A neverending<br />
task for regulators in<br />
Europe?<br />
Session 1501<br />
New requirements for missing<br />
data handling - a problem that<br />
affects every submission<br />
Session 1503<br />
Patient Skills Working Lunch<br />
12:45 -13:45<br />
Session 1504<br />
Student Special Session<br />
Session 1505<br />
Agency Satellite Session<br />
18:<strong>00</strong>-19:30<br />
Session 1507<br />
Japanese Regulatory Session<br />
Session 1508<br />
Pharmaceutical Medicine<br />
Session 1601<br />
Non-Clinical Safety<br />
Session 1602<br />
CMC/Quality Session<br />
under development<br />
Session 1603<br />
CMC/Quality Session<br />
under development<br />
Session 1604<br />
CMC/Quality Session<br />
under development<br />
Session 1605<br />
CMC/Quality Session<br />
under development<br />
Session 1606<br />
Study Endpoints<br />
Session 1607<br />
PIM<br />
Session 1608<br />
The Future of Telematics in<br />
Europe<br />
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