Theme 1 | Clinical operations
Estrella Garcia, Head of Global Clinical Operations, Almirall S.A., Spain
The evolving regulatory and technology landscape in clinical development is becoming more and more challenging. The Clinical Operations theme will discuss several initiatives, and how they are affecting the efficiency and management of clinical trials. Amongst others, how the risk based monitoring approach is being implemented by the industry, how health economy evaluation dossiers are considered in clinical development plans and how virtual communities are being implemented in overall trial management.
Finally, patients' involvement and performance in clinical trials is key to success. New approaches on how to inform, involve, maintain and monitor patients will be presented.
Theme 2 | Technical operations
Julianne Hull, CEO, WenStar Enterprises, UK
Encompassing CDM, eClinical, validation and technologies, this theme aims to address the key aspects of technical operations throughout the lifecycle of a clinical development programme. Sessions and presentations will provide recent experience on:
- planning and implementation of risk based monitoring,
- really achieving a paperless clinical trial,
- using technology to drive process and delivery optimisation,
- eSource, CDISC and ensuring real time data availability,
- agile and script free validation,
- cloud computing and the changing regulatory environment.
Theme 3 | Medical affairs
Heike Schön, Managing Director, LUMIS International, Germany
Medical Affairs is the discipline combining concepts of clinical research and real-life healthcare requirements. It is the transformation of what was accomplished during the clinical trials and the approaches to meet market requirements. This often requires finding innovative ways of involving patients, of identifying new opportunities to gather data through innovative study approaches, e.g. virtual studies, and of bridging the pharmacovigilance requirements from clinical trial results to post marketing evaluations. These key topics will be addressed during the sessions and the theme will be topped off by experts reflecting on best approaches to delivering high value publications from clinical trials and post marketing studies.
Theme 4 | Medical information
Aaron Cockell, Medical Information Regional Director, EMEA, Pfizer Inc., UK
The European Medical Information and Communication Conference takes place as part of the Annual DIA Clinical Forum. We are in the 7th 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: The Value of Medical Information, PV Legislation, Evidence Based Medicine and MI, MI Quality, Medical Information in emerging markets, Regional and Global Management aspects, Technology and Social Media 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.
Theme 5 | Medical writing
Mary Gardner Stewart, Divisional Director, Medical Documentation, H. Lundbeck A/S, Denmark
The Medical Writing sessions will focus on the current hot topics within Medical Writing. These topics include the implications and impact of the new EU pharmacovigilance guidelines on various safety documents, including risk management plans (RMPs), an update on current issues related to clinical trial registries, including a heads up on what to expect with the coming EudraCT V9 and keeping registry postings in mind when preparing protocols and clinical study reports, regional considerations for global submissions, with particular focus on Asia, storyline documents (for example, briefing or regulatory response documents) for use in pre-submission meetings and non-guidance driven interactions with the regulatory authorities, submission challenges, including managing multiple indications and sharing of best practices for the response process for eCTD questions in the EU, and sharing of best practices on how to successfully handle the often difficult review process.
Watch this page for frequent updates and more details!
Download the current programme flyer (PDF)