Clinical Trial Disclosure & Transparency London, UK. 22nd May London SDE

Transcription

1 Clinical Trial Disclosure & Transparency London, UK 22nd May 2014 London SDE

2 Welcome Dear Single Day Event Attendee, Welcome to London, It is our great pleasure to welcome you to this event. For the sixth year, we are running a series of Single Day Events across Europe: Frankfurt (Germany), Copenhagen (Denmark), Brussels (Belgium), Basel (Switzerland) and London (UK) are our destinations this year. We are hoping that give a great opportunity to network and meet colleagues from other companies during the year while waiting for the main conference, which will take place in progression and drive for thought leadership within our industry that we would like to welcome you to the the future of clinical trials and potential use of healthcare data? and provide us with high standard locations and catering facilities to fully enjoy the day. and also will help us to promote the event. Also you will notice that this year and we will review any comments or suggestions you make with great interest and will try to action them for future events. Best regards, Adrienne Bonwick (Eisai) and Kathryn Wright (Cmed) PhUSE EU Single Day Event Chair Organisers 2014 These events give a great opportunity to network and meet colleagues from other companies Michael Whitworth (Accenture) and Michael Harris (Amgen) PhUSE London Single Day Event Chairs London SDE 2014 London SDE

3 Agenda Speakers and abstracts Time Title and speaker Welcome and Introduction Setting the scene with Transparency Accenture Amgen An Academic Researchers Perspective on Data Transparency Sarah Nolan Liverpool University A View from the Regulator Jim Slattery EMA Setting up the Pharma System: Operational aspects of sharing patient information and data sharing Roche Clinical Trial Data Transparency: Current progress and moving towards one multi-sponsor environment Andy Bayliss SAS Data Transparency: Qualiance Panel Discussion Closing Remarks Accenture Amgen Setting the scene with Transparency Accenture Amgen Biographies year history and has a keen interest in the ongoing discussions regarding clinical data transparency. 4 London SDE 2014 London SDE

4 Speakers and abstracts An Academic Researchers Perspective on Data Transparency Sarah Nolan Liverpool University trial data analysis including the importance of data access meaning of transparency for the academic researcher, essential the academic researcher to the data provider. Biostatistics at the University of Liverpool, United Kingdom. Sarah is an Author and Statistician for the Cochrane Epilepsy current issues around data sharing and data transparency in academic research. A View from the Regulator Jim Slattery EMA During the presentation, Jim will review the European Jim Slattery is a Biostatistician employed at the European worked on drug regulation with an emphasis on drug safety. give a realistic account of himself (or anyone) in a few words 6 London SDE 2014 London SDE

5 Speakers and abstracts Setting up the Pharma System: Operational aspects of sharing patient information and data sharing Roche Clinical Trial Data Transparency: Current progress and moving towards one multi-sponsor environment Andy Bayliss SAS might look like. challenges, lessons learned and opportunities and not least that we are still continuing to learn and adapt. years whilst working at Novartis and also travelled the world. and several pharmaceutical companies have done similar move forward on this including external image and reputation, early compliance to expected guidelines, as well as proactively direction. With this presentation, Andy will cover the following main topics: he has focused on helping companies explore and exploit their data using advance analytics. In his current role Andy industry. 8 London SDE 2014 London SDE

6 Speakers and abstracts Upcoming events Data Transparency: Consultant & Owner, Qualiance review of the current initiatives, challenges and important researchers. While data privacy is of utmost importance for patients who participated in clinical trials, it is important that researchers meaningful and that they can understand. At the same time, pharmaceutical companies want to make sure relevant utilized to support the process. of processes and regulations and their implementation. Copenhagen, Denmark Basel, Switzerland Bridgewater, Brussels, Belgium Business & Decision Life San Francisco, California, USA Annual Conference - Data Transparency Grange Tower Bridge Hotel, London Keep up to date with events and more at PhUSE.eu 10 London SDE 2014 London SDE

7 Conference Highlights: Keynote Speakers from FDA and EMA Dedicated Session on Data Transparency 15 Streams & 2 Discussion Clubs paradigm shift towards cloud computing? Cross-industry forum (based on the CSS Emerging Technologies workgroup) PhUSE Scriptathon Opening Keynote Speaker: Chris Geiger Author of The Cancer Survivors Club and Bad Cells Two Hands-on Workshops to attend: CDISC SDTM & ADaM Business & Decision Life Sciences Clinical Trial Data Transparency Delivering on the Promise SAS Workshops are FREE to attend and limited to 50 attendees per workshop so book up now to avoid disappointment. Early Bird Registration Closes 27th June To book a place at the conference visit: London SDE 2014 Conference Chair: Pierre Mayeur (IDDI) Conference Co-Chair: Chris Price (Roche)