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Your Tailored Research & Development Agenda

Suggested agenda for attendees interested in Pharmacovigilance

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 “Biologics R&D in Austria: Innovation and Sustainable Patient Access” by Joerg Windisch, Chief Science Officer at Sandoz Biopharmaceuticals.

Wednesday 26 March

Translation Of Personalised Medicine Concepts
9:00-10:30 AM
This session addresses the latest scientific developments driving personalised medicine, adaptive trial concepts supportive of personalised medicine and early scientific advice for the development of personalised medicine from regulators, HTA bodies and payers.

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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.

Hurdles To Overcome To Ensure Regulatory Success For The Next Generation Of Products
11:00 AM-12:30 PM
One of industry’s key responses to the EU’s Horizon 2020 programme is to initiate a series of work streams to investigate new models for R&D. This session will outline the business needs for change within both industry and at the regulator level and will explore what needs to be done to ensure a successful evolution.

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Innovation Through Public-Private Partnership Collaborations
11:00 AM-12:30 PM
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.

Innovation in Biomarkers and Disease Stratification
2:00 PM-3:30 PM
The use and impact of innovative pharmacogenomic biomarkers in several areas of medicine will be addressed with case studies, as well as highlighting the latest advancements in the molecular diagnostics field.

Innovation in Clinical Trial Design and Evaluation
4:00-5:30 PM
Clinical research will be addressed from the perspective of enhancing study design methodologies and transparency combined with a continuous learning loop to provide the best personalised patient care possible.

Thursday 27 March

Innovation in Drug Delivery Systems and Compliance
9:00-10:30 AM
Innovative drug targeting, topical administration, in situ forming systems and new biomaterials will be discussed. The session will also address the important role of the patient in the development of drug delivery systems to create innovative solutions and innovative ways to improve patient compliance with treatments.

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European Commission’s eHealth Action Plan 2012-2020
9:00-10:30 AM
The ‘eHealth Action Plan 2012- 2020, Innovative Healthcare for the 21st Century’ aims to utilise eHealth to address current health care challenges. The activities can be largely divided into four groups: 1. achieve wider interoperability in eHealth services; 2. support research, development, innovation and competitiveness in eHealth; 3. facilitate uptake and ensure wider deployment of eHealth and 4. promote policy dialogue and international cooperation at global level. The Action Plan emphasises activities at the EU level, but it encourages all stakeholders such as national and regional authorities, health and social care providers, professional organisations, researchers and patients being active in this area and working closely together.

Innovation in Pre-Clinical and Clinical Safety Sciences
11:00 AM – 12:30 PM
Presentation topics will include “Safety Assessment of Advanced Therapies,” “Predictability of Non-Clinical Safety Models, Present and Future in Debate,” and “Novel Insight into Drug Hypersensitivity Mechanisms through Integration of Immunogenetics, Metabolism, Biochemistry and Preclinical Models.”

Non-Clinical Development Strategies for Biosimilar Monoclonal Antibodies

2:00-3:30 PM
This session will provide a reflection on the need for innovative methods for non-clinical assessment of biosimilar monoclonal antibodies from a regulators and industry perspective and finally gives a view on globalised development strategies.

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Big Data, eHealth Records and Taxonomy
2:00-2:30 PM
Find out about the goal of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) 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.

Pharma Industry Incentive Systems
4:00 PM – 5:30 PM
Speakers will highlight topics such as: “Creating a Future for the Pharma Industry through Innovation Ecosystems,” “How Close are we to ‘Targeted’ Medicines?”, and “Are Current Incentive Systems Facilitating the Introduction of Targeted Medicines?”