About Arena s Clinical Trial Series Confirmed Speaking Faculty

Transcription

1 About Arena s Clinical Trial Series The Clinical Trials Conference series launched over a decade ago and now runs in more than 14 locations worldwide. The acclaimed series is a platform for biopharmaceutical and medical device professionals to collaborate with service providers and other industry stakeholders to find innovative solutions to the most pressing challenges in conducting clinical trials. Thousands of clinical professionals attend our conferences year after year. The Outsourcing in Clinical Trials: Medical Devices Europe conference has been developed specifically to meet the needs of the vibrant life sciences hub here. The agenda has been developed through direct collaboration with and support from the local industry to ensure the conference is content-driven and addresses the practical needs of our attendees Confirmed Speaking Faculty Hindrik Robbe, Director Clinical Affairs EMEA Abbott Dorota Johansson, Clinical and Research Director - Bactiguard Gary Carpenter, Head of Clinical and Regulatory Affairs - BioSure Elke Sommerijns, Senior Clinical Trial Manager - Boston Scientific Hongwei Zhang, Senior Manager Clinical Affairs - Carl Zeiss Meditec Juliette Cook, Regional Regulatory Director EMEA Cochlear Andrew Thompson, Director of Therapy Research and Analysis, Medical Devices - GlobalData Megan Critser, Global Head Regulatory Affairs & Quality Medical Devices - Guerbet Roland Kirchner, Director Biofunctional Devices Leukocare Olli Keränen, Chief Executive Officer - Medtentia Jani Virtanen, Director of the Regulatory Affairs Medtentia Angela Birt, Industry Operations Manager NIHR Clinical Research Network Marta Carnielli, Senior Manager, Quality, Regulatory and Compliance EMEA - Ortho Clinical Diagnostics Beate Hanson, Vice President, Head Global Clinical Strategy - Smith & Nephew Bassil Akra, Vice President - Global Focus Teams - TUV SUD Miguel Angel Hernandez, Medical Devices Safety Surveillance Lead - UCB Pharma Itoro Udofia, Head of Medical Devices - UL International Further Information For sponsorship opportunities please contact: Alex O Leary AlexanderOLeary@arena-international.com Tel: For programme enquiries please contact: Elizabeth Williams Elizabeth.Williams@arena-international.com Tel:

2 Outsourcing in Clinical Trials: Medical Devices Europe 6 th 7 th February 2019 Programme Day One 08:15 Registration and refreshments 08:50 Chair s opening remarks [Spotlight] Status of implementation of the medical device regulation in Europe 09:00 High level overview of the medical device regulation and its timeline Current status of the notified body designation process Summary of the new clinical data requirements Details regarding the planned transparency with the new legislative framework Bassil Akra, Vice President - Global Focus Teams, TUV SUD 09:30 Session reserved for Premier Research [Panel Discussion] MDR Gap Assessment - how are we getting on with it? 10:00 Exploring SME company views on how to build MDR plans with limited budget and resources Uncovering Post Market Clinical Follow-up requirements to ensure your device maintenance in the market Discussing accessibility for Predicate Device documents and potential bills for biocompatibility tests Sharing experiences on internal and external resources brought on to meet increased requirements Juliette Cook, Regional Regulatory Director EMEA, Cochlear 10:30 Morning refreshments and networking FDA market review speeding up US market approvals with European trial data 11:00 Comparing the similarities with the MDR and FDA requirements to build clinical strategies Supporting US and EU clearance in a single trial: Harmonization of requirements to ensure trials efficiency Assessing the potential cost generating factor in your US trials and if your budget is affordable for 2 in 1 trial strategies Informing study design from a commercialization perspective, not just regulatory approval Andrew Thompson, Director of Therapy Research and Analysis, Medical Devices, GlobalData 11:30 Session reserved for NAMSA

3 Navigating benefits and pitfalls of clinical trials in China in light of global regulatory changes 12:00 Understanding the Chinese government policy on growing clinical trials and product launches in China Comparing regulatory similarities on medical device conformity assessments in Europe vs China Assessing cost benefits from patient accessibility and infrastructure in the study area Considering having internal staff who can oversee Chinese trials with fluent communications Hongwei Zhang, Senior Manager Clinical Affairs, Carl Zeiss Meditec 12:30 Lunch and networking [Interview] Reviewing the Brexit negotiations Expected implications for UK certified devices 13:30 Discussing expected challenges for companies conducting clinical trials in GB for long-term To what extent could working with local CROs in the UK minimise risk post-brexit Explaining what British Notified Bodies are preparing in the Brexit era and the expected impact on your devices certified from them Looking into the crystal ball what will a post-brexit regulatory regime look like in the UK? Itoro Udofia, Head of Medical Devices, UL International 14:00 Session reserved for ICON Maximising return on investment from Investigator Initiated Trials with least engagement in the study 14:30 Building strategies to cooperate with your investigator in setting up the protocol and subject registration Outlining adverse event/serious adverse event reporting in IITs and who is responsible for it Determining efficiency of onsite monitoring versus remote monitoring to ensure getting useful clinical data for your PMS Considering electronic data capture system to ensure smooth overseeing of the study process and reporting Hindrik Robbe, Director Clinical Affairs EMEA, Abbott 15:00 Afternoon refreshments and networking 15:30 Strategic point: how to choose clinical sites and what are the criteria that can save you time and money?

4 Checking if the studies in similar therapies have been conducted in the hospital Working closely with your marketing and sales team to double-check site ability and its strategic role Talking to medical staff in the hospital to design the study which adds value to you and to the site Sharing how to select A Key Opinion Leader and what are the criteria Running small trials with your candidates before moving into larger pivotal trials Dorota Johansson, Clinical and Research Director, Bactiguard 16:00 Session reserved for Syntactx Delving into challenges in the planning and execution of Early Feasibility Studies 16:30 Evaluating the essential factors necessary for establishing protocols Underlining the considerations that need to be taken into account when deciding to conduct EFS studies outside of Europe to avoid delays during the study Investigating challenges for EFS studies done in multiple locations to get enough data you are looking for Cooperating regulatory consultancy and data monitoring vendors to ensure the trial stays on track Olli Keranen, CEO, Medtentia Jani Virtanen, Director of the Regulatory Affairs, Medtentia Importance of stabilising the biological component in combination devices to ensure full biologic activity and effectiveness in clinical trials and beyond 17:00 Contents to be confirmed Roland Kirchner, Director Biofunctional Devices, Leukocare 17:30 Chair s summary and close of conference Outsourcing in Clinical Trials: Medical Devices Europe th 7 th February 2019 Programme Day Two 08:15 Registration and refreshments 08:50 Chair s opening remarks 09:00 Exploring the usage of Big Data in clinical trials - where to find resources and how to contract

5 Contents to be confirmed Beate Hanson, Vice President, Head Global Clinical Strategy, Smith and Nephew Syneoshealth Maximising your MedTech opportunity in the UK's National Health Service (NHS) 09:30 Enhance your marketing strategy by bringing your product to clinical trial in the NHS Understand the UK's clinical research infrastructure and free support services Learn how to access: fool-proof feasibility; streamlined site identification; quicker costing and contracts; rapid recruitment; and proactive performance management Experience the power of the Network approach in practice - real-life video case studies Angela Birt, Industry Operations Manager, NIHR Clinical Research Network Discussing which is the best outsourcing model for your study size and device type 10:00 Understanding increased requirements on clinical evidence and what help can put you on fast track Discussing how much to outsource with your internal resources to maintain the quality of your study Developing the best balance of cost and quality of your study with budget considerations Exploring what technologies are in the market to streamline and optimize your trials Inspecting potential weaknesses in your in-house resources and the impact this would have on trial progression Elke Sommerijns, Senior Clinical Trial Manager, Boston Scientific 10:30 Morning refreshments and networking Developing a strategic plan for IVDs with increased requirements from an Industry perspectives 11:00 Clarifying the new requirements for clinical evidence under the IVDR Overviewing the expectations Notified Bodies and Competent Authorities have for manufacturers under IVDR Comparing the differences between EU and US requirements on IVD to harmonise both market requirements during clinical planning stage Sharing experiences and challenges on implementing UDIs from a manufacturer s perspective Gary Carpenter, Head of Clinical and Regulatory Affairs, BioSure

6 Evaluating the impacts of IVDR on Companion Diagnostic manufacturers 11:30 Examining what the new classification system means for IVD manufacturers Assessing how much clinical data needed when you reclassified from Self-certified device to Notified Body certified device Discussing procedures manufacturers need to take to meet these new requirements and when these procedures need to be started Clarifying the expectations Notified Bodies and Competent Authorities have for manufacturers Dr Jaap Jansen, Arkray 12:00 Lunch and networking Highlighting data security for your study in threatening cyber environment to keep your patient data safe and compliant with GDPR 13:00 Outlining IRB s view of patient data security to ensure approval Reviewing regulations pertaining to patient data protection including GDPR to avoid data privacy violations in trials Comparing on-site model and cloud-based models considering cost, convenience and security Investigating the role of Data Centre and internal regulatory professionals in validate of standards and processes for data management and security Megan Critser, Global Head Regulatory Affairs & Quality Medical Devices, Guerbet [Agenda Highlight] Where are we now? Post Market Surveillance System Requirements and the transition to the MDR 2017/745 for currently CE Marked devices 13:30 Implementation plan of existing gaps in PMS System as per the MDR (2017/745) PMS System, PMS Plan, PMS Report & PSUR PMCF Plan, PMCF evaluation report, and CER Focus on serious incidents reporting & FSCA Trend report, incident analysis, FSCA & vigilance data Use of EUDAMED in post market surveillance Miguel Angel Hernandez, Medical Devices Safety Surveillance Lead, UCB 14:00 Industry updates: Post Market Surveillance requirements and EUDAMED development Building new processes to comply with Vigilance and post-market surveillance requirements of the IVDR

7 Integrating Quality Risk Management with complaint management An update on the status of the electronic system on vigilance and post-market surveillance Marta Carnielli, Sr. Manager, QRC EMEA, Ortho Clinical Diagnostics 14:30 Afternoon refreshments and networking Speaker Hosted s 15:00 Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each roundtable session lasts for 45 minutes, and delegates may attend up to 2 roundtables 1 Highlighting trial design stage to facilitate the on-going smooth running of your study Dorota Johansson, Clinical and Research Director, Bactiguard 2 Building strategies for clinical trials in China under changing cfda regulations Hongwei Zhang, Senior Manager Clinical Affairs, Carl Zeiss Meditec 3 Sharing experience with increased clinical evidence requirements under the IVDR Gary Carpenter, Head of Clinical and Regulatory Affairs, BioSure 4 Discussing expected challenges for UK certified devices in Europe for long-term (Tentatively) Itoro Udofia, Head of Medical Devices, UL International 5 Reserved for Anagram-IEC 16:30 Chair s summary and close of conference