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09:00AM – 05:30PM
2018 Topics and Thought Leadership Streams
Data and Data Standards
Preclinical Development and Early-Phase Clinical
Translational Medicines and Science
Value and Access
9 Programme Topics
The Programme Topics for DIA Europe 2018 reflect the key interests of our DIA constituents, and address forward-thinking questions in the industry.
Topic A: Can Regulators and HTA Bodies Create Synergies for Patient Access?
Jordi Llinares Garcia
Head of Scientific and Regulatory Management, Human Medicines Evaluation Division, European Medicines Agency (EMA), EU
Topic B: What are Necessary Steps towards Outcome-Driven Health Systems?
BCG Market Access Roundtable Steering Committee,USA
There is a lot of discussion currently on the shift from volume-based to value-based care delivery. This requires adequate infrastructure, capability and outcomes assessment to ensure appropriate reward for innovation and value delivered. In multiple sessions, the topic of ‘Outcomes Driven Health Systems’ will address key questions related to this theme.
Topic C: Medicines of the Future: What Will Innovation Need and Bring?
Head of Sector Regulatory Affairs Committee Support and Community Procedures, European Medicines Agency (EMA), EU
Strategic Innovation Leader, Pharma Development F. Hoffmann-La Roche, Switzerland
Topic D: How Can Better Outcomes Be Enabled by Big Data?
Isabelle de Zegher
Vice President, Integrated Solution, PAREXEL Informatics, Belgium
Director General, Danish Medicines Agency (DKMA), Denmark
Personalised Medicine, demand for early treatment, genomic treatment and increased complexity of trials force us to rethink the way we approach clinical development, moving from 7-12 years of work to 3-5 years for most of the products. This topic explores why we think Big Data will enable a different approach in clinical development, how it will enable this change and what we should do as an industry to maximise the value of Big Data, learning from other industries and adapting our competencies.
Topic E: What is the Future of Pharmacovigilance?
Head of Affiliate Safety and Compliance Excellence, QPPV, AbbVie, UK
Head of Signal Management, European Medicines Agency (EMA), EU
The importance of pharmacovigilance continues to increase along with complexities in data collection, scientific methodology, technology advances and resource constraints. This session will take a look at innovative approaches to benefit/risk management, risk communication and measuring the impact of pharmacovigilance activities and discuss the experience with recently implemented elements of the Pharmacovigilance legislation.
Topic F: What Can Stakeholders Expects from Clinical Trial (Development), Transparency and Medical Information?
Director, Global Clinical Registry, Novo Nordisk, Denmark
Transparency and open information on clinical research is reaching new levels, since the International Committee of Journal Editors (ICMJE) in 2004 published their requirements for public trial registrations, as a prerequisite for publication in the scientific literature. Today transparency of information is done to satisfy ethical policies for openness as well as to meet regulatory requirements and guidelines globally. It covers information on protocols, clinical reports, summaries for lay persons and sharing of data with independent researchers for use in secondary analyses. Provision of the information has led to building new areas of responsibilities, working processes at trial sponsor- as well as at regulatory institutions, to ensure transparency and handle compliance.
Topic G: A New Era for Medical Devices and Diagnostics. How Is The Impact?
Head Device Development & Commercialization, Biologics Technical Development & Manufacturing (BTDM), Novartis, Switzerland
Topic H: Drug Development and Regulatory Approval - Reference Points around the Globe or Globalisation?
Global Price and Reimbursement Director, AstraZeneca, Gothenburg, Sweden
Global Head, Development & Regulatory Policy & Intelligence, Novartis, USA
Increasing globalisation of drug development is a fact – but how do regulators and the regulated industry around the world keep pace with it? Harmonisation of requirements is expanding to new regions, reliance on each other’s evaluations and other means of work sharing are on the rise. Learn more about how we can make globalisation of drug development work!
Topic I: How Can We Enable Clinical Research in Europe Further?Holger Maria Rohde
Director, Regulatory Project Management, Merck, Germany
Head of Division, Inspections, Human Medicines Pharmacovigilance and Committees, European Medicines Agency (EMA), EU
Major changes being brought about by upcoming regulations will require transformations in development organisation for the facilitation of efficacious clinical research in Europe. The increasing availability of real word data raises challenges as to how it can be integrated, validated and used. Organisations need to adapt to regulatory requirements and opportunities which enable new research methodologies at the interface of regulatory, data science and patient’s needs.