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Programme Overview

Programme Overview 

Theme 1 | Patients

Theme 2 | Clinical Research

Theme 3 | Clinical Operations

Theme 4 | Drug Safety and Risk Management

Theme 5 | Peri- and Post-Approval Studies

Theme 6 | Medical Information and Communications

Theme 7 | eClinical/CDM

Theme 8 | Validation

Download the Advance Programme for details.


Theme 1 | Patients 

Patient centricity and patient empowerment are true paradigm shifts, fuelled by rising complexities in health research, the ubiquity of the internet, technology innovation as well as an increasingly proactive patient community. It has become a major driving factor of clinical innovation. Already today, well informed patients and patient advocacy groups have a key role to play in the implementation of a patient-centred research agenda, providing unique knowledge and insights into unmet medical needs and research priorities. It is important that clinicians and researchers are prepared to work with patient advocacy groups and communicate effectively with patients about clinical trials. This year’s theme “The Empowered Patient” will pick up many of these issues, e.g. how to communicate with patients about research, how to partner with advocacy groups on clinical trials, what influence “e-patients” have on research, and how quality of life research influences the research agenda.

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Theme 2 | Clinical Research 

If you stop to consider this year’s theme, “The Empowered Patient”, you might be forgiven for thinking that up until now patients did not have any rights when it came to clinical trials. Regardless of the fact, we are all faced today with emerging patient expectations and their growing role both as a stakeholder and as a partner in clinical research.

This becomes most evident when direct involvement of informed patient advocacy groups leads to an improvement both in the overall quality of clinical projects and in requirements to make research results available to the patients. Empowered Patients and their advocates claim they want to understand their options for reasons of transparency, meaningful interaction and active participation in clinical research, as well as for encouraging investigator excellence, and self-defining forms of certification and standardisation. Society, on the other hand, increasingly demands “value for money”, resulting in numerous requirements for economic evaluation of a drug during development.

In the Clinical Research Theme, these aspects are addressed from various perspectives, and varying, successful approaches are presented.

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Theme 3 | Clinical Operations 

Adaptive trial design, extrapolation of global clinical data and increasing utilisation of e-technologies are some of the headline issues affecting clinical operations. Alongside this, more traditional questions around investigator effectiveness, subject engagement and site performance remain to be fully resolved. This theme will present new thinking in both these aspects of clinical trial operations with a focus on practical experience and case studies.

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Theme 4 | Drug Safety and Risk Management 

The new EU Pharmacovigilance (PV) legislation on authorised medicinal products effective from July 2012 onwards represents the largest revision of the regulatory framework since 1995. The new legislation has implications for many safety relevant processes and eliverables which already have to be considered during clinical development. The changes put a strong emphasis on the benefit-risk evaluation and quality systems. The following sessions will address key topics encompassing a range of drug safety and risk management activities.

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Theme 5 | Peri- and Post-Approval Studies 

The peri- and post-approval study landscape is still developing very rapidly. The new EU legislation, needs from market access and other initiatives lead to an increase in complexity of large late-stage and post-marketing studies. The new legislation presents unique challenges for the study teams; therefore it is necessary to get alignment in the organisations regarding strategy, processes, tools, governance, regulatory requirements and implementation rules. It can be observed that the expectations from regulators, medical community and internal stakeholders regarding opportunities, data quality and scientific value of such studies have increased significantly. This theme presents new ideas and developments and encourages an open dialogue with experts in the field.

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Theme 6 | Medical Information and Communications 

The European Medical Information and Communication conference takes place as part of the annual DIA Clinical Forum. We are in the 6th year of this unique meeting organised by medical information professionals specifically for medical information professionals.

Each year, speakers share hands-on experience with current challenges as well as successes in medical information departments. Participants are encouraged to take part in workshops and discussions within the sessions. This year, our themes are operational excellence, global medical information challenges, medical information in emerging markets, metrics and key performance indicators, patients and medical information, digital engagement, and the popular putting theory into practice session.

The content will be of particular interest to managers and leaders of medical information services. Participants will also have the opportunity to network with their peers and gather ideas for enhancing their services.

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Theme 7 | eClinical/CDM 

Technology and regulations are ever changing. We need to be aware and to keep current! This year’s eClinical/CDM theme will help you to keep abreast of the changing environment from the new centralised and risk based monitoring FDA and EMA guidelines through eSource and the most current use of Electronic Health Records for real time data capture.

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Theme 8 | Validation 

The pharmaceutical industry is further moving to the e-data era, enabled by a highly complex set of interfaced computerised systems. Whilst the basics of computer system validation has been generally understood and executed well, the ever increasing complexity of the IT system landscape, in combination with tight IT budgets and the increasing data integrity and data privacy requirements require us to continuously challenge the status quo. Using automated testing to improve validation efficiency, but also leveraging new technological opportunities such as cloud computing supported by outsourcing and off-shoring partners will be discussed.

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