08:50
Dr Olav Flaten
Medical Director
GlaxoSmithKline
Opening remarks from the Chair
A look into the future of the industry and the role of e-clinical trials to maximise profitability of the organisation
09:00
Dr Olav Flaten
Medical Director
GlaxoSmithKline
Keynote: Moving forward with fully electronic systems to maximise the efficiency of clinical trial performance
- Dealing with the increasing amount of data and outlining the necessity of standardisation and full interoperability of e-clinical trial systems
- Evaluating the current legislative framework and guidelines to ensure regulatory compliance
- Outlining the development of EHRs (Electronic Health Records) as a reality and what that means for the pharmaceutical and healthcare industry
- Exploring trends – an outlook into the future and new technologies already materialising on the horizon
09:30
Gunter Bellaire
Director, Strategic eClinical Operations
Perceptive Informatics
An e-Clinical vision for the future – gaining full business benefits
- Shifting focus from data integration to defining interoperability that simplifies user workflow
- Identifying how e-tools improve performance measurement and proof of ROI
- Convergence of technologies and consolidation of data to improve clinical trial performances
- Platform considerations to deliver this vision
10:00 Morning refreshments and networking
The way forward – analysing the current and future developments of EHRs (Electronic Health Records)
10:30
Joris Van Dam
IT Director Health Information Technology
Johson & Johnson
Exploring the future of the pharmaceutical and healthcare industry – the benefits of EHRs becoming a reality
- Outlining the current status of EHRs and how they link patient care, clinical research and public health
- Identifying the benefits and opportunities of EHRs for the pharmaceutical industry and how they will change the market landscape
- Dealing with the challenges of EHRs data integration into electronic data management systems
- Analysing the safety and ethical issues arising from EHRs
- Uncovering the regulatory framework and HL7 standards for EHRs
11:00
Panellists:
Joris Van Dam
IT Director Health Information Technology
Johson & Johnson
Dr Olav Flaten
Medical Director
GlaxoSmithKline
Panel session: Maximising the market share of a biosimilar product by utilising efficient marketing and pricing strategies to secure market share
- Establishing how the e-clinical landscape will look with EHRs in place
- Analysing the interoperability challenges of EHRs and existing e-clinical systems
- Clarifying if EDC will become redundant when EHRs become an established reality
- Speculating who will cover the costs to put EHRs systems in place in Europe
- Determining USA’s ambition of having EHRs for all citizens in place by 2014
11:30
Mirelle Zerola
Data Management Specialist
Boehringer Ingelheim
Discussing how RDC can optimise relationships with
Data Monitoring Committees (DMC)
- Review the increasing demands of DMCs within Clinical studies
- How does RDC and e-source o er solutions?
- Communication strategies
- Case study - demonstrating the success of weekly transfers of data to DMC
1200 Lunch and networking
Maximising clinical trials performance with efficient utilisation of e-tools
13:00
Massimo Raineri
Head of Systems Development – Biometry
Actelion
Case study: A pioneer’s point of view on utilising digital pens to maximise the efficiency of clinical trials
- Improving quality of data and timelines for clinical trials by implementing digital pens in clinical trial conduction
- Outlining the benefits of this technology and device and how it improves clinical trial outcomes
- Establishing user friendliness and looking at how it can get improved
- Ensuring the captured results are fully 21CFR Part 11 compliant to guarantee legislative approval
13:30
Ingela Larsson
Head Clinical Trials
Janssen-Cilag
Maximising clinical trial performance from an
operational company point of view
- Outlining how electronic CRFs help to reduce time on data query management and how this benefits your clinical trial timelines
- Speeding up data collection by implementing an eCRF accustomed to your study needs
- Optimising clean data collection by sophisticated automatic data checking
- Exploring how eCRFs simplify remote monitoring processes of your clinical trial performance
14:00
Henrik Nørgaard Rasmussen PhD
Principal Consultant, Life Sciences Division,
NNIT A/S, Denmark
Essentials in the process of optimising clinical development
- Starting point for an improved clinical development process
- Interfaces and technology
- One-size project does not fit all organsations
- Proven methodology
14:30 Afternoon refreshments and networking
Practical case studies of efficient utilisation of e-tools in clinical trials
15:00
Detlef Nehrdich
Director Statistics, Data Management & EDC Project Office Europe, Global Statistics & Data Management
Abbott
Efficient data cleaning strategies
- Sharing responsibilities: who cleans what?
- Understanding when it’s best to clean data to maximise process efficiency
- The importance of appropriate process definition and compliance tracking
- Defining quality of data – how much is enough?
15:30
Dirk Langeneckhardt
Head Data Management Coordination
Merck Serono
A new approach for CRO partnering: implications
for Data Management
- Optimal exploiting of resources
- Introduction of deliverable based contracts and
management of deliverables rather than day-to-day activities
- Electronic data standard and transfer requirements
- Link of quality and quantity measures
- Quality expectations
- Data quality surveillance activities
16:00
Ivo Abraham
PhD Matrix45
Unithink
Can Eclinical be considered as the way forward for Phase 4 and 5 studies?
- Presentation of a client case study on selection and implementation of an eclinical platform for a Phase IV study
- Discussion of the benefi ts of using eclinical systems in Phase IV trials
- Considerations in selecting the right system with particular reference to Phase IV trials
- Benefits of new delivery models; software as a service
- Developing and maintaining vendor relationships for successful trial delivery
16:30
Hans Martens
Associate Quality Consultant
Eli Lilly
An auditors point of view: ePRO audits &
investigations to maximise system efficiency
- Outlining applicable regulations and expectations, including ICH-GCP and 21 CFR Part 11 to ensure compliance
- Introducing the FDA guidance on ePRO and computerised systems
- Analysing important aspects of computerised systems: security, business continuity, infrastructure to maximise efficiency of systems
- Identifying the most effi cient models for computer system validation
- Identifying fundamental elements of data quality to achieve optimal results
- Understanding eRisks and successful strategies to overcome them
17:00
Hans Martens
Associate Quality Consultant
Eli Lilly
Speed networking session
To facilitate the networking opportunities at this event we will be running a “speed networking session”. Delegates will be able to take part in discussion sessions with other speakers,
delegates and sponsors in an informal environment.
We recommend you bring plenty of business cards to make best use of this opportunity.
17:30 Closing remarks from the Chair and end of Day 1
Programme Day Two
