So much so that the meeting’s Oxford-style plenary debate will focus on whether or not patients have enough knowledge and understanding to take part in clinical research, with investigators and patients’ representatives to speak for and against the motion, ‘This house believes that patients are not fit to be informed participants in clinical research’. Another plenary session ‘Patients on Trial’ will examine the human rights issues around patient involvement in clinical trials.
It is very apt then that The Hague in The Netherlands, with its numerous international tribunals, such as the International Court of Justice in the Peace Palace should be the venue for a Clinical Forum geared to international collaboration and to encouraging the exchange of ideas and best practices amongst individuals from a wide variety of countries and organisations.
‘The Programme Committee is working on developing an engaging and thought provoking agenda that focuses on patients and their healthcare needs’, said Programme Chair, Ms Janet Davies, Director, International Medical Information and Medical Affairs Project Management, Gilead Sciences, UK. ‘The emphasis is very much on sharing knowledge and experience in a multidisciplinary environment and learning what works and what doesn’t – in ways that are both informative and useful.’
Pre-event workshops will take a very practical approach to the issues of the day. For example, Risk-Based Monitoring, with particular emphasis on the new regulatory guidelines and making comparisons between the EU and the US, will offer tips on implementing the new guidelines together with useful advice on what companies need to do to drive their own monitoring. Another workshop will examine the future of the regulatory clinical trials environment.
Conference tutorials in development include one on CDISC standards where detailing the data flow will be the theme; another will deal with data privacy in clinical trials and pharmacovigilance.
Patient oriented themes
In the Patients theme, Mr Jan Geissler, EUPATI and Patvocates, Germany, and Mr Detlef Niese, Head, Development External Affairs, Novartis Pharma AG, Switzerland, will chair sessions on how best to manage communications throughout the clinical trial process and how to work effectively with patient advocates to help ensure a positive trial outcome.
Mr Holger Maria Rohde, Medical Operational Officer, Teva Pharma, Germany, and Ms Simone Breitkopf, Medical Director, Clinical Development and Medical Affairs, Shire, Germany, lead the Clinical Research theme. Sessions include horizon scanning, early benefit assessment – duplications for clinical research, partnering with patient advocacy groups in clinical research, communicating clinical trials: recruitment, results, and registries. There is also a session on ACRES (Alliance for Clinical Research Excellence and Safety): an innovative approach to reforming clinical research.
Helping investigators and patients to perform better in clinical trials is the mainstay of Theme 3, Clinical Operations, led by Ms Estrella García, Head of Global Clinical Operations, Almirall SA, Spain, and Mr Nermeen Varawalla, Founder and CEO, ECCRO, UK.
The Drug Safety and Risk Management theme is co-chaired by Ms Mariska Kooijmans-Coutinho, Vice President Safety and Benefit–Risk Management and EU QPPV, Biogen Idec Ltd, UK, Ms Monika Pietrek, Managing Director, Pietrek Associates GmbH, Germany, and Mr Maarten AC Lagendijk, Pharmacovigilance Coordinator, Medicines Evaluation Board, The Netherlands. The sessions embrace safety operations and their quality systems in a hybrid model, managing external interfaces under the new pharmacovigilance legislation, timely updates of investigator brochures and alignment with other reference safety information as well as practical considerations in adapting the new RMP/PSUR template.
Theme 5, Peri- and Post-Approval Studies examines transparency and governance in NIS (Non-Interventional Studies), new methodologies advancing post-approval research and innovative approaches. Mr Paul Jäkel, Head of Global Non-Interventional Studies, Bayer Pharma AG, Germany, and Ms Heike Schön, Managing Director, CSG Clinische Studien GmbH, Germany, are the session leads.
Theme 6, Medical Information and Communications led by Mr Aaron Cockell, Medical Information Regional Director, EMEA, Pfizer Ltd, UK, and Ms Lillian Auberson, Senior Director, Head of Global Medical Information, Actelion Pharmaceuticals Ltd, Switzerland, will cover not only EU but also global issues and is designed to appeal to even the most experienced practitioners. Sessions will be highly interactive sessions and will address key trends and topical issues, including the role of Medical Information in communicating with patients.
The eClinical/CDM theme is led by Mr Valdo Arnera, General Manager Europe, PHT Corporation, Switzerland, Ms Julianne Hull, CEO, WenStar Enterprises, UK, Mr Pierre-Yves Lastic, Senior Director, Data Privacy & Healthcare Interoperability Standards, Sanofi, France, Mr Detlef Nehrdich, Senior Associate, Waife & Associates, Inc, Germany, Mr Graham Bunn, VP Partnerships, Medidata Solutions, UK, and Mr Peter Stokman, Head Global Data Management & Standards Oss, MSD, The Netherlands. It examines ePro from validation to elderly patient delivery, centralised and risk based monitoring, migration from one system to another - the challenges and the essentials, patient driven data exchange as well as new technologies and Electronic Health Records.
In Theme 8, Validation, Mr Rolf Banholzer, Global Head CQA Computerized System Services, Novartis Pharma AG, Switzerland, and Mr Breffni Martin, Director, Optuminsight Strategic Regulatory Services, Ireland, lead sessions on ePro from validation to elderly patient delivery, tips and tricks on validation, cloud computing in the quality guidelines (GxP) regulated environment, outsourcing and off-shoring challenges in validation environment.
In special student dedicated pre-sessions experts from the industry will offer practical advice on career path selection with the first in a series of ‘A day in the life of’. Delegates will be given tips on CV writing and on how to make the best out of meetings such as the Clinical Forum. In addition, DIA Europe promotes the participation of students and young professionals in the Clinical Forum through its Student and Young Professional Fellowship Programme, offering up to 10 complimentary registrations.
In keeping with the meeting’s theme, DIA Europe also promotes the participation of patients in the 6th Annual Clinical Forum, with a full Fellowship Programme and additional complementary registrations.
The 6th Annual Clinical Forum takes place from 8–10 October 2012 at the World Forum, The Hague, The Netherlands. For more information and for Fellowship application forms go to http://www.diahome.org/Home/Flagship-Meetings/CF2012.aspx > or contact Ms Kaija Kurki-Suonio, Event Manager and Volunteer Services Coordinator, at DIA Europe email@example.com