Conference Programme
| Conference | |
|---|---|
| 08.00 | Registration |
| 08.50 | Opening remarks from the chair |
Strategic challenges in late phase drug development |
|
| 09.00 | The strategies you must employ in comparative clinical and cost effectiveness requirements to ensure access to new medicinesThe strategies you must employ in comparative clinical and cost effectiveness requirements to ensure access to new medicines |
| 09.30 | Late Stage Drug Development: a specialty medicines market access perspective· Issues related to cross-indication pricing and Market access
· Moving from “time to submission” to “re-imburseable submissions”
· Commercial and development trade off’s in order to ensure successful re-imbursement Late Stage Drug Development: a specialty medicines market access perspective |
| 10.00 | Major policy developments that impact on real world evidence development
Major policy developments that impact on real world evidence development |
| 10.30 | Focused phase IV trials both for patient subgroups and regional payer and regulatory demandsFocused phase IV trials both for patient subgroups and regional payer and regulatory demands |
| 11.00 | Morning refreshments and speed networking |
| 12.00 | Is the cost of late phase development sustainable?Is the cost of late phase development sustainable? |
Evidence and value development |
|
| 12.30 | Informing the commissioning process of providers and payers- Evidence development to inform commissioning process and purchasing decisions of payers and providers Addressing payer and provider data needs beyond Health Technology Assessments Strategies to create tailored evidence for business decisions at account level Informing the commissioning process of providers and payers |
| 13.00 | Balancing the needs of payers and prescribers in the design of global
phase IIIb/IV studies |
| 13.30 | Lunch |
Post approval data management |
|
| 14.30 | New and emerging sources of healthcare and patient data for post approval studiesNew and emerging sources of healthcare and patient data for post approval studies |
| 15.00 | Site management and monitoring in real world research - fit for purpose, efficient approachesSite management and monitoring in real world research - fit for purpose, efficient approaches |
| 15.30 | PROs: Measuring and assessing patient reported benefits of a productPROs: Measuring and assessing patient reported benefits of a product |
| 16.00 | Refreshments |
Building a comprehensive clinical profile of therapeutics in the real-world |
|
| 16.20 | A case study in managing a long term registry to a successful conclusionThis Case Study will outline managing operational considerations in a five year Registry of 15,000 patients to a successful conclusion. The presentation will address the following:Identification and training of investigatorsManaging patient enrollment within 6 monthsMinimize lost to follow up and maintain retention rateOvercoming Data Management Obstacles A case study in managing a long term registry to a successful conclusion |
| 16.50 | Drugs in the Wild: Sense and Sensibility of Studying Medicines in Real-Life Clinical Practice• Why study medicines in real life?What approaches are there?Internal and external validity: Do they matter?Concrete methodological recommendations Drugs in the Wild: Sense and Sensibility of Studying Medicines in Real-Life Clinical Practice |
| 17.20 | Closing remarks from the chair and end of day one |
| 17.30 | Networking drinks reception |
| Conference | |
|---|---|
| 08.00 | Registration |
| 08.50 | Opening remarks from the chairOpening remarks from the chair |
Challenges in pharmacovigilance |
|
| 09.00 | New EU Pharmacovigilance regulations: how safety commitments can federate multiple countries around a common strategy• Review of EU legislation and Global Pharmacovigilance Practices for non-interventional PASSOperational impact: EU and ex-EU implementation from protocol to data collection that combine overall objective and local expectations of various stakeholders New EU Pharmacovigilance regulations: how safety commitments can federate multiple countries around a common strategy |
| 09.30 | Moving forward after the implications of the new EU legislation on pharmacovigilanceMoving forward after the implications of the new EU legislation on pharmacovigilance |
| 09.55 | The Role of Epidemiology in the New EU Pharmacovigilance LegislationThe Role of Epidemiology in the New EU Pharmacovigilance Legislation |
| 10.20 | Safety in numbers: Monitoring risk in approved drugsSafety in numbers: Monitoring risk in approved drugs |
| 10.45 | Role of Observational and Non-Interventional Study Designs in Safety ResearchRole of Observational and Non-Interventional Study Designs in Safety Research |
| 11.10 | Refreshments |
Drug utlisation studies and methodologies |
|
| 11.40 | Drug Utilisation Studies: Opportunities and Challenges
Drug Utilisation Studies: Opportunities and Challenges |
Medical affairs in late phase |
|
| 12.10 | How real world evidence is effecting medical affairsHow real world evidence is effecting medical affairs |
| 12.40 | Lunch |
Real world case studies |
|
| 13.40 | Collecting data on real-life clinical practice regarding safety, efficacy and patient complianceCollecting data on real-life clinical practice regarding safety, efficacy and patient compliance |
| 14.10 | Observational drug trials post-registration provide the best clinical data for physicians and patients. Madness or Fact?Observational drug trials post-registration provide the best clinical data for physicians and patients. Madness or Fact? |
| 14.40 | Experience from more than 20.000 patients in Non-Interventional Studies: A view of the possibilities within Case-Controlled epidemiology designsExperience from more than 20.000 patients in Non-Interventional Studies: A view of the possibilities within Case-Controlled epidemiology designs |
| 15.10 | Sharing more than 25 years of experience: observational studies of endocrine patients with rare diseases: do’s and don’ts learnt over the yearsSharing more than 25 years of experience: observational studies of endocrine patients with rare diseases: do’s and don’ts learnt over the years |
| 15.40 | Closing remarks from the chair |
| 15.50 | End of conference and refreshments |
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