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CCH - Congress Center Hamburg

Apr 06, 2016 9:00 AM - Apr 08, 2016 5:30 PM

Am Dammtor / Marseiller Str., 20355 Hamburg, Germany

28th Annual EuroMeeting

Agenda

9:00 AM — 10:30 AM

Benefit-Risk Management Planning through the Life Cycle of a Product

9:00 AM — 10:30 AM

Challenges and Best Practices for Writing Lay Summaries of Clinical Study Results

9:00 AM — 10:30 AM

Innovation for Patient Reporting

9:00 AM — 10:30 AM

New European Clinical Trial Regulation: A New Paradigm with Major Impact on Clinical Trial Stakeholders

9:00 AM — 10:30 AM

New Medical Device Regulations in the EU

9:00 AM — 10:30 AM

Patient-Focused Medicine – To Understand Patients You Must Engage Them

9:00 AM — 10:30 AM

PRIME Initiative Launch: Fostering Timely Access for Patient-Focused Drug Development

9:00 AM — 10:30 AM

Regulatory Science Hand in Hand with Health Technology Assessment for Better Outcomes

9:00 AM — 10:30 AM

Translation of Cell and Gene Therapies

9:00 AM — 10:30 AM

What Happens in and Around Europe – Beyond the European Union?

9:00 AM — 10:30 AM

Women’s Health and Drug Development

11:00 AM — 12:30 PM

Communicating Benefit-Risk Information in Risk Management Plans to Medical Professionals and the General Public

11:00 AM — 12:30 PM

Fast Forward to the Future – How Big Data and Artificial Intelligence Will Change Our Regulatory Environment

11:00 AM — 12:30 PM

Gene Therapy – A New Treatment Modality: Opportunities and Challenges from a Patient’s, Industry, Regulatory and Payer’s Perspective

11:00 AM — 12:30 PM

ICH E6- GCP Addendum: Risk Proportionate Approaches to Trial Design and Conduct

11:00 AM — 12:30 PM

Perspectives on Medication Errors

11:00 AM — 12:30 PM

Physician Engagement, Education and Communication in an Era of Transparency

11:00 AM — 12:30 PM

Public Expectation vs. Regulatory Complexity: Scenarios for Safe Innovation in Medical Technology

11:00 AM — 12:30 PM

Real-World Evidence (RWE) in Drug Development – Creating the Right Environment for Enhanced Pre-Launch Evidence

11:00 AM — 12:30 PM

Strengthening of Regulatory Systems: How is it Achieved and When?

11:00 AM — 12:30 PM

Symposium – Frailty as a Baseline Stratification Parameter and Potential Therapeutic Target

11:00 AM — 12:30 PM

The Needs of the Payers Shape the Evidence for Market Access

2:00 PM — 3:30 PM

Assessing the Benefits and Risks as the Basis of Benefit-Risk Management

2:00 PM — 3:30 PM

Clinical Trial Disclosure

2:00 PM — 3:30 PM

Digital Health: How Digital Technology is Transforming Health Care

2:00 PM — 3:30 PM

End-to-End Pharmacovigilance Quality and Compliance

2:00 PM — 3:30 PM

Innovative Developments in Medical Technology

2:00 PM — 3:30 PM

Preparing Clinical Documents for Public Release: The Issues of Transparency and Redaction

2:00 PM — 3:30 PM

Real-World Data Making Personalised Medicine a Reality

2:00 PM — 3:30 PM

Securing the Supply Chain: How to Tackle the Challenges

2:00 PM — 3:30 PM

Shall HTA Depend on Randomised Controlled Trials (RCT) or Real-World Data (RWD) or Both?

2:00 PM — 3:30 PM

The Future of Regulatory Affairs is Digital – Key Success Factors for Regulatory Affairs in a Rapidly Changing Environment

2:00 PM — 3:30 PM

The Voice of the Patient – Innovative Ways of Patient Engagement in R&D

4:00 PM — 5:30 PM

Adaptive Pathways and Conditional Approval – Panel Discussion

4:00 PM — 5:30 PM

Combination Products

4:00 PM — 5:30 PM

Conduct and Completion of Paediatric Development Plans, As Agreed in Paediatric Investigative Plans (PIPs) or Paediatric Study Plans (PSPs)

4:00 PM — 5:30 PM

Import Testing: Current Requirements and Opportunities to Simplify Access of Medicines for Patients

4:00 PM — 5:30 PM

Japanese Regulatory Session: PMDA Update

4:00 PM — 5:30 PM

Post-Authorisation Safety and Efficacy Studies: Scientific Challenges and Factors for Success

4:00 PM — 5:30 PM

Start–Ups Meet Regulatory and Industry – How Can Ideas from Academia Be Best Translated to Novel Treatment Options? What Kind of Partnerships Are Required?

4:00 PM — 5:30 PM

The Reality of Real-World Evidence – How Various Stakeholders Are Working With RWE to Improve Patient Outcomes

4:00 PM — 5:30 PM

Using Computer-Assisted Writing to Increase the Efficiency of Creating Regulatory Documents

4:00 PM — 5:30 PM

Value Proposition, Challenges and Examples for the Use of Big Data in the Pharmaceutical Industry

9:00 AM — 10:30 AM

Challenges and Opportunities Related to the Integration of Multiple Data Sources

9:00 AM — 10:30 AM

Content and Context of IDMP

9:00 AM — 10:30 AM

Enhancing Clinical Trials Efficacy: Operational Excellence and Continuous Improvement of Clinical Research Processes

9:00 AM — 10:30 AM

Formulations for Both Ends of Life

9:00 AM — 10:30 AM

How Can Three Parties- Payers, Industry and HTA - Make Agreements and Share the Economic Risk?

9:00 AM — 10:30 AM

Improving Global Health: How Can Regulators Help?

9:00 AM — 10:30 AM

Improving Productivity in R&D

9:00 AM — 10:30 AM

It´s Never Too Soon – Early Access and Early Dialogue in Drug Development

9:00 AM — 10:30 AM

Post-Authorisation Safety and Efficacy Studies: Operational Challenges and Factors for Success

9:00 AM — 10:30 AM

Post-Marketing Surveillance and CE Marketing

9:00 AM — 10:30 AM

Setting the Scene – Is There an Availability Problem in Europe?

11:00 AM — 12:30 PM

Cutting Blockbuster Indications into Orphan-Sized Bites

11:00 AM — 12:30 PM

Evolving Areas of Regulatory Science

11:00 AM — 12:30 PM

From Tradition to Regulation – Globalisation of Herbal Medicines

11:00 AM — 12:30 PM

MAPPs: The IMI ADAPT SMART Project

11:00 AM — 12:30 PM

Medicinal Products in Need

11:00 AM — 12:30 PM

New Approaches to the Approval of Innovative Medicines: Do They Keep Their Promise?

11:00 AM — 12:30 PM

Oxford Debate: ‘This House Believes that Over-Engineered Clinical Development Has Inhibited Innovation’

11:00 AM — 12:30 PM

Planning and Oversight for Success

11:00 AM — 12:30 PM

Self-Care Medical Devices: Shifting Borders between Devices and Pharma?

11:00 AM — 12:30 PM

Understanding Important Risks and the Evolution to Benefit-Risk Management Planning

11:00 AM — 12:30 PM

Use of Extrapolation in Paediatric Drug Development: Can We Achieve Global Agreement through the Revision of the ICH E11 Paediatric Guideline?

2:00 PM — 3:30 PM

Development of New Medicines – Engaging with Stakeholders

2:00 PM — 3:30 PM

Effective and Balanced Risk Communication

2:00 PM — 3:30 PM

HTA for Medical Devices

2:00 PM — 3:30 PM

Innovation in the Development and Approval of Generic Medicines

2:00 PM — 3:30 PM

Innovation of Mature Products – New Uses for Old Products

2:00 PM — 3:30 PM

MAPPs: The IMI ADAPT SMART Project

2:00 PM — 3:30 PM

No Marketing of Authorised Products

2:00 PM — 3:30 PM

Shaking the Toolbox: Evolutions in Approaches in Trial Design

2:00 PM — 3:30 PM

The Growing Role and Importance of Interoperability and Standardisation

4:00 PM — 5:30 PM

Bringing NGS into Drug Development: The Impact of Sequencing on the Future of Clinical Trials and Drug Registration

4:00 PM — 5:30 PM

Challenges for Academic Clinical Trials

4:00 PM — 5:30 PM

European Relative Effectiveness Assessments

4:00 PM — 5:30 PM

Examples of Big Data Applications

4:00 PM — 5:30 PM

Expect the Unexpected: Challenges and Opportunities in the Clinical Development of Biopharmaceuticals

4:00 PM — 5:30 PM

Impact of Regulatory Measures to Optimise Benefit/Risk Decisions

4:00 PM — 5:30 PM

IVDs and Companion Diagnostics

4:00 PM — 5:30 PM

Shortages of Authorised Products

4:00 PM — 5:30 PM

Where is the Orphan Drug Journey Going?

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