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Your Tailored Clinical Research Agenda

Suggested agenda for attendees interested in Clinical Research

Tuesday 25 March

Austrian Satellite Meeting
11:00 AM-12:30 PM
The theme for this session is “Austria – An Attractive Research and Business Location”. It will include a presentation on “Clinical Research in Austria” by Markus Müller, Vice Rector, Medical University of Vienna and a speech on “OKids – Austrian Paediatric Research Network” by Christoph Male, Associate Professor of Paediatrics, Medical University of Vienna.

Wednesday 26 March 


The Importance For All to Adopt the New Paradigm in Clinical Research: Introductory Session
9:00-10:30 AM
Attendees will be brought up to speed on the various pan-industry initiatives over RBM. The speakers will situate RBM in the context of optimising drug development, the regulatory framework for conducting research and its impact on study participants.

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Patients as Partners in Clinical Research
9:00-10:30 AM
Speakers will highlight topics including “Increasing Health Literacy and Making Doctor-Patient Communication More Effective,” “Communicating Clinical Trials: Combining Regulatory Obligations and Patient Recruitment” and “Empowering and Educating Patients in Medicines R&D,” followed by a panel discussion.

Disclosure of Clinical Trial Data - What Does the Future Hold?
11:00 AM-12:30 PM
This session will review the legal principles that govern the release of clinical trial data to third parties, such as researchers but also the public in general. The principles governing reactive and proactive will be discussed, as well as the latest status of the litigation before the EU courts, and the new Clinical Trials Regulation and its potential impact on transparency. 

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Innovation through Public Private Partnership Collaborations
11:00 AM-12:30 PM
Modern information and communication technologies are reinforcing and expanding PPPs beyond all previous limitations and boundaries. Together with the insight that certain innovations are unfeasible without inter-organisational collaboration today PPP programs hold a great promise. Outcomes of the largest EU PPP program, IMI, will be discussed. In addition, legal, IP and collaboration management aspects within such large scale PPPs will be addressed.

The New Paradigm In Clinical Research: The Case For Develop- Ing New Roles, Skills And Competencies
2:00-3:30 PM
The presenters will discuss how the changes in monitoring practices call for adapted competencies in those who work closely on the collection of study data. The debate will focus on ways and means to maximise the acquisition of these adapted competencies.

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Innovation in Biomarkers and Disease Stratification
2:00-3:30 PM
Genomic and epigenetic biomarkers offer great promise in refining the development and clinical application of new and existing medicines, and for assessing disease risk. The use and impact of innovative pharmacogenomic biomarkers in several areas of medicine will be addressed with case studies highlighting the latest advancements in the molecular diagnostics field.

Optimising Clinical Research: Which Infracturial and Business Relationship Changes do we Need to Consider?
4:00-5:30 PM
Consider the changes required to the established infrastructure for providing clinical research services to accommodate risk based monitoring. The evolution in the business relationships over outsourcing will be specially addressed.

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Data Integration: Reaching The Next Level Of Efficiency
4:00-5:30 PM
Find out about approaches that take the next technological steps and how these could completely change the way clinical research is done today.

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Efficient Use Of Social Media To Work With E-Patients
4:00-5:30 PM
Presentation topics will include: “Patient-Centric Engagement in Clinical Trials and the Digital Age,” “Collaborating with Patient Organisations via Social Media to Optimise Drug Development,” and “The Power of Patient-Driven Communities and their Role in Research: The RareConnect Example.”

Thursday 27 March

Innovative Methodologies Used In Enhancing Quality

9:00-10:30 AM
Hear from expert speakers as they focus on specific novel methodologies that tackle three challenging aspects of drug development and improve quality. 

Workshop: The New Paradigm In Clinical Research: Stakeholder Perspectives For A Rational Process
11:00 AM-12:30 PM
In the first part, the speakers will focus on the rationale and applicability of prioritising limited resources to crucial sectors. Key regulatory documents will be analysed and drivers such as ‘proportionality’ will be reviewed. In the second part, ‘complicating factors’ will be discussed in small groups.

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Innovation in Preclinical and Clinical Safety Sciences
11:00 AM-12:30 PM
The poor prediction of toxicity during early drug development is a major challenge to bringing more effective medicines to patients. Key opportunities for enhancing safety sciences include improved characterisation of molecular, biochemical and cellular pathways of toxicity, together with the development of predictive tools, models and translational safety biomarkers that allow discovery researchers and clinicians to anticipate and mitigate safety issues. A safe harbor approach for amassing preclinical/clinical safety data and exploring chemotype-toxicity relationships is essential for an improved information flow between bedside and bench. 


Big Data, eHealth records and Taxonomy

2:00-3:30 PM
The goal of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is to further strengthen the post-authorisation monitoring of medicinal products in Europe by facilitating the conduct of multi-centre, independent, post-authorisation studies focusing on safety and on benefit/risk, using available expertise and research experience across Europe. Gathering this kind of data in ONE taxonomy database leads to greater interoperability between pharmaceutical industry, healthcare professionals and patients. However, until now there has been a shortage of fully integrated informatics solutions that can handle data from multiple sources. Integration of these multiple platforms might achieve personalised medicine in the future.

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Systematic Approaches to Deliver Quality: Learn From The Experts!
2:00-3:30 PM
In this session, three experts reflect on practical ways to achieve quality, addressing the topics of “Applying Risk Assessment in Risk-Based Monitoring,” “Realising Time and Cost Savings through Protocol Design Planning Improvements” and “What Can Safety Engineering Teach Us About Better Controlling Clinical Safety and Managing Risk?”

The Brave New World of Digital Data: What are the New Legal and Ethical Questions?
4:00-5:30 PM
Address some of the ethical and legal repercussions of collecting patients’ data digitally. The potential impact on data privacy will be covered, as well as the likely education that subjects will need to enable them to make informed decisions on the release of their personal data.