Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

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Monday, March 8, 2010 Session 1 16:30 - 18:00 Reception 18:30-20:00 Tuesday, March 9, 2010 Session 2 09:00 - 10:30 Coffee Break Session 3 11:00 - 12:30 Lunch Session 4 14:00 - 15:30 Coffee Break Session 5 16:00 - 17:30 Wednesday, March 10, 2010 Session 6 09:00 - 10:30 Coffee Break Session 7 11:00 - 12:30 Lunch Session 8 14:00 - 15:30 52 DIA 22nd Annual EuroMeeting 2010 at a Glance Theme 1 Theme 2 Theme 3 Theme 4 Theme 5 Innovation Session 0101 The Innovative Medicines Initiative Session 0102 Is an Open Innovation Paradigm the Way Forward for Pharma? Session 0103 The Importance of Pre- Competitive Data Sharing to Accelerate Drug Development Session 0104 What is an Innovative Medicine? Session 0105 Innovation in Early and Late Phase Clinical Trials I Session 0106 Innovation in Early and Late Phase Clinical Trials II Session 0107 Have the Benefits of Translational Medicine Been Realised? Session 0108 Innovation to Reduce Attrition Staying in Business: How to make sure you comply with all rules and regulations, quality, compliance and external challenges Session 0201 Transparency: A Pandora’s Box or a Panacea? Session 0202 The Price of Globalisation: Bringing modern therapies to developing countries or only including patients in trials? Session 0203 The Price of Globalisation: The costs, benefits, risks and pitfalls when moving development and manufacturing to Latin America Session 0204 Counterfeiting: Who owns the problem? Who is in control? Session 0205 Misuse of Medicines and Doping: What is the problem, how big is the problem? Session 0206 Quality Risk Management: Myth, promise or a solution to the operational challenges of clinical development and regulatory compliance? Session 0207 CTTI (Clinical Trial Transformation Initiative): What has been achieved, has it already delivered on the expectations raised? Session 0208 Governance Challenges When Managing Partners Such as CROs and Licensing Partners Paediatric Medicines on their Way to Patients Session 0301 Regulatory Challenges and Experience with New Paediatric Requirements Session 0302 Design and Conduct of Ethical Paediatric Clinical Programs Session 0303 Focusing on Pharmacovigilance and Safety Aspects of Paediatric Trials Session 0304 Paediatric Development - Is a global strategy achievable? Session 0305 Paediatric Formulations- Will they reach the market? Session 0306 Harmonised Regulatory Expectations for Juvenile Animal Testing? Session 0307 Challenges under the Paediatric Regulation to Obtaining the SPC Extension Session 0308 Initial Impact of the Paediatric Regulation after 3 years Decision Making: The key to efficient and effective drug development, approval and access Session 0401/1001 Patient Influence on Regulatory Decisions: How much do they and should they have? Session 0402 Transparency and Related Safeguards Session 0403 Conditional Approvals: How to Strike the Right Balance between Early Access, Patient Safety and Commercial Reality Session 0404 Clinical Trials: The Demise of Traditional Surrogate Markers? How to Create New Markers? Paving the Way for Therapies- Foster generations of biote derived medic Session 05 CAT Experience in th Session 05 ATMP Border Session 05 ATMPs and Biother Do they require ch established qua manufacturing co Session 050 Impact of New The Pre-Clinical Res Session 0405 The True Value of Risk Session 05 Management for Decision Making Clinical Resea and for Post-Approval New Therapies - New Commitments Session 0406 The Benefit/Risk Assessment of Medicines in the Approval Process: Developing a Structured Approach to Decision Making? Session 0407/0807 Influence of HTA on Regulatory Decision Making: Reality? An Opportunity? A Threat? Session 0408 Company Decision Making during Drug Development Session 050 Biosimilars- F Developments and Challenge Session 05 Advanced Therapies Devices – Living with Management re Session 05 Health Technology A - Are they possible fo therapies?
Advanced ing new chnologyines 01 e First Year 2 lines 3 apeutics – anges to ity and ncepts? 4 rapies on earch 5 rch: Challenges 6 ture egulatory s 7 and Medical a new Risk ality? 8 ssessments r advanced Theme 6 Theme 7 Theme 8 Theme 9 Theme 10 T Challenges for Switching from Prescription to Non-Prescription Status through the Centralised Procedure Session 0601/0901 Risk Management for Switch Products Session 0602 Are the Incentives Provided in Legislation Sufficient to Boost Innovation at the EU level? Session 0603 Switching Trends: Evolution or revolution? Session 0604 ‘Central Switches’ – Where are we going ? Session 0605 Could the UK Model Be Reproduced at the EU level ? Session 0606 Impact of the EU Decision on Non-Prescription Status at the National Level Session 0607 Information to Patients/Consumers: Fit for Purpose? Session 0608 New Chance for Well-known Substances: CP or MRP/DCP PLENARY 13:30-16:00 Personalised Medicines Session 0701 Personalised Medicines: What is it, where do we stand and where are we going? Session 0702 Is Europe Adapted to Personalised Medicines? What Needs to Change over the Next 10 Years? Session 0703 One Medicine Does Not Fit All. What Has Worked and What Can We Learn? Session 0704 Biomarker Qualification Process - How does it work and where does it fit? Session 0705 Efficacy: Evidence & study designs in Personalised Medicines Session 0706 Safety: Evidence & study designs in Personalised Medicines Session 0707 Diagnostics – If this is such a crucial element of the whole field, what are we doing to support, encourage and protect the diagnostics field? Session 0708 International Regulatory Frameworks – Converging or diverging? Taking the European Regulatory Infrastructure Forward Session 0801 Pharmaceutical Package- The Latest Information Session 0802 International Co-operation between Regulatory Agencies Session 0803 Heads of Medicines Agencies Session 0804 Simultaneous Global Development: Present hurdles, future considerations and opportunities Session 0805 CHMP Overview Session 0806 Dialogue and Scientific Advice: Achieving Goals and Making it Happen Session 0407/0807 Influence of HTA on Regulatory Decision Making: Reality? An Opportunity? A Threat? Session 0808 Changes in Regulatory Agencies Meet Future Challenges Risk Management The Informed Patient e Session 0601/0901 Risk Management for Switch Products Session 0902 Regulatory Developments in Risk Management in the EU and US Session 0903 Non-Clinical Support to Aid Risk Management in Early Phase Studies Session 0904 When Do Adverse Events Qualify as Undesired Effects? Session 0905 Research and International Initiatives in Risk Management Session 0906 Performance, Quality Control and Audit in Pharmacoviglance and Risk Management Session 0907 Risk Minimisation- Is it Worth the Pain? Session 0908 Pandemic Vaccines Session 0401/1001 Patient Influence on Regulatory Decisions: How much do they and should they have? Session 1002 Pharmaceutical Package: Information to Patients Proposals – What difference will they make? Session 1003 Communication of Information on Medicinal Products (1) – How can a balance be achieved between legal restrictions and patient expectations? Session 1004 Communication of Information on Medicinal Products (2) – Factors to consider to ensure optimum accessibility and understanding Session 1005 Are Informed Patients Cost- Effective? How to ensure that patients understand the decisions being made on their medicines Session 1006 How Involved Can Informed Patients Be in the Development and Commercialisation of Medicines? Session 1007 Patient Use of Information on Medicinal Products Session 1008 What Information Do Patients Want on Medicinal Products and How Far Do the Current Provisions Go To Meet These Needs? Se The New IT Meeting t e Ses Patient and Outcomes Us Product Deve on industry regul 53 Ses EDC C Ses Emerging Optimisa Tr Ses Improving D the Use of Ses Healthcare St Ses Utilisation of Records in C Ses Connectin Clinic
Page 1 and 2: 22nd Annual E UROM EETING Monaco 20
Page 3 and 4: Welcome from the EuroMeeting 2010 C
Page 5 and 6: Plan Your EuroMeeting Experience! S
Page 7 and 8: Special Sessions Student and Young
Page 9 and 10: Session Topics in Specific Interest
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Page 13 and 14: This is a preliminary programme. Ne
Page 17 and 18: Greening the EuroMeeting: Towards a
Page 39 and 40: discovery and development. This is
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Page 48 and 49: Monaco - Surprisingly Affordable Ho
Page 50 and 51: 50 Networking Opportunities Network
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Page 56: REGISTRATION FORM ID# 10101 22nd An

Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

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