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DAY TWO
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DAY TWO
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10:00 - 10:055 mins
Welcome to Day Two of Clinical Trials Europe
- Louisa Maitland - Conference Director, Informa
10:05 - 10:2520 mins
Partnerships and Outsourcing in Clinical Trials (1)
How to reduce the lead time and improve the DM processes using a lean methodology approach
- Virginie Van de Velde - Senior Manager Oversight Data Manager, GSK Vaccines, Belgium
10:05 - 10:2520 mins
Partnerships and Outsourcing in Clinical Trials (2)
GDPR: General overview, implementation, debated issues and learnings so far
- Kristof Van Quathem - Senior Privacy and Technology Lawyer, Covington & Burling LLP, Belgium
10:05 - 10:2520 mins
Operations in Clinical Trials (1)
The future of research in primary care and collaborations with primary care federations/primary care networks to facilitate recruitment
- Andre Krzeminski - Lead Research GP, Albany Health, UK
10:05 - 10:2520 mins
Operations in Clinical Trials (2)
Adaptive clinical trials from an ethics perspective
- Krista Tromp - Medical Ethics and Philosophy, Erasmus University, The Netherlands
10:05 - 10:2520 mins
Technology in Clinical Trials (1)
Actual experiences working with Virtual trials
- Rasmus Hogreffe - Head of Virtual Clinical Trials, Leo Innovation Lab, Denmark
10:05 - 10:2520 mins
Technology in Clinical Trials (2): Artificial Intelligence
A real world evaluation using NHS data to compare 100% remote digitally-enabled Type 2 Diabetes structured education & behaviour change programmes Vs face to face Type 2 diabetes structured education programmes
- Ralphael Oghagbon - Health Economist, Imperial College Health Partners, UK
10:25 - 10:4520 mins
Partnerships and Outsourcing in Clinical Trials (1)
How can Quality Tolerance Limits support COVID-19 impact assessments
- Marion Wolfs - Associate Director Risk Management and Central Monitoring, Janssen, The Netherlands
10:25 - 10:4520 mins
Partnerships and Outsourcing in Clinical Trials (2)
EU Clinical Trials Regulation; An update of the current status and some thoughts on its implementation
- Sol Yates - Associate Director, Global Regulatory Affairs, Grünenthal GmbH, Germany
10:25 - 10:4520 mins
Operations in Clinical Trials (1)
The application of data Science in Feasibility - how to get a better predictability of average recruitment and retention rate?
- Danny Hasselbaink - Global Feasibility Lead, Janssen Biologics B.V., The Netherlands
10:25 - 10:4520 mins
Operations in Clinical Trials (2)
Collaborative working from the very start –view from a primary care site perspective
- Olivia Barnes - Senior Research Nurse, Sherbourne Medical Centre, UK
10:25 - 10:4520 mins
Technology in Clinical Trials (1)
AstraZeneca learning's from a decentralized hybrid trial in adolescent patients with asthma
- Henrik Forsman - Clinical Innovation Director, AstraZeneca, Sweden
10:25 - 10:4520 mins
Technology in Clinical Trials (2): Artificial Intelligence
The ethics of clinical trials and the ethics of AI: Establishing real-world common ground between researchers and patients
- Francis Crawley - Executive Director, Good Clinical Practice Alliance - Europe (GCPA) & Strategic Initiative for Developing Capacity in Ethical Review (SIDCER); Leuven/Brussels, Belgium
10:45 - 11:0520 mins
Partnerships and Outsourcing in Clinical Trials (1)
Spotlight Presentation: Re-starting your clinical trial program? QPS is ready
10:45 - 11:0520 mins
Partnerships and Outsourcing in Clinical Trials (2)
Spotlight Presentation: Available
10:45 - 11:0520 mins
Operations in Clinical Trials (1)
Spotlight Presentation: Covance
10:45 - 11:0520 mins
Operations in Clinical Trials (2)
Spotlight Presentation
10:45 - 10:5510 mins
Technology in Clinical Trials (1)
Spotlight Presentation
- Alexandre Malouvier - Director Global Data Strategy, PRA Health Sciences, France
10:45 - 11:0520 mins
Technology in Clinical Trials (2): Artificial Intelligence
Spotlight Presentation: ERT
10:55 - 11:0510 mins
Technology in Clinical Trials (1)
Spotlight Presentation
11:05 - 12:0560 mins
Networking
LIVE Networking Forum
11:05 - 11:105 mins
Tech Tour
Improving clinical research access: Lessons learned from minority patient and physician feedback
- Rosamund Round - Vice President, Patient Innovation Center, Parexel International, UK
11:10 - 11:155 mins
Tech Tour
Title TBC: Medable
12:05 - 12:2520 mins
Partnerships and Outsourcing in Clinical Trials (1)
Quantifying participant diversity in clinical trials
- Kenneth Getz - Deputy Director and Professor, Tufts Center for the Study of Drug Development Tufts University, USA
12:05 - 12:2520 mins
Partnerships and Outsourcing in Clinical Trials (2)
What is the Regulators’ view on the future of clinical research
- Nikolai Brun - Director of Division, Chair HMA-EMA Taskforce on Big Data, Copenhagen Area, Capital Region, Denmark Medical Evaluation and Biostatistics, DKMA, Denmark
12:05 - 12:2520 mins
Operations in Clinical Trials (1)
How research sponsors can support sites to adopt new technologies to deliver excellence in clinical research
- Jennifer Nielsen - Process Development Specialist, Novo Nordisk AS, Denmark
12:05 - 12:2520 mins
Operations in Clinical Trials (2)
Real world trials and RWD in trials and healthcare data related topics
- Amanda Lucas - Programme Director, Imperial College Health Partners, UK
12:05 - 12:2520 mins
Technology in Clinical Trials (1)
Novo Nordisk’s learning's from implementing DTP (Shipment of IMP from site to patients’ home)
- Birgitte Denlow - GCP Advisor Specialist, Global Clinical Quality & Intelligence, Novo Nordisk, Denmark
12:05 - 12:2520 mins
Technology in Clinical Trials (2): Artificial Intelligence
Deep machine understanding and predictive modeling of clinical trial quality data to drive consistency and efficiency
- Deepak Bandyopadhyay - Associate Director of Quality Analytics,, Janssen, USA
12:25 - 12:4520 mins
Partnerships and Outsourcing in Clinical Trials (1)
Spotlight Presentation: IQVIA Technologies
12:25 - 12:4520 mins
Partnerships and Outsourcing in Clinical Trials (2)
Spotlight Presentation: Available
12:25 - 12:4520 mins
Operations in Clinical Trials (1)
Spotlight Presentation: Optimizing the entire clinical trial financial lifecycle through automation
- Faisal Shahzad - Project Manager (EU), Greenphire, UK
- Zach Hales - Product Manager (US), Greenphire, USA
12:25 - 12:4520 mins
Operations in Clinical Trials (2)
Spotlight Presentation: ERT
12:25 - 12:4520 mins
Technology in Clinical Trials (1)
Spotlight Presentation: Medable
12:25 - 12:4520 mins
Technology in Clinical Trials (2): Artificial Intelligence
Spotlight Presentation: MRN
12:45 - 13:2540 mins
Partnerships and Outsourcing in Clinical Trials (1)
LIVE PANEL with Q&A: Regulatory challenges for clinical trials
- Maren von Fritschen - Regulatory Affairs, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Belgium
- Kristof Van Quathem - Senior Privacy and Technology Lawyer, Covington & Burling LLP, Belgium
- Sol Yates - Associate Director, Global Regulatory Affairs, Grünenthal GmbH, Germany
- Corrette Ploem - Associated Professor, University Medical Centre (UMC) Amsterdam, Netherlands
12:45 - 13:2540 mins
Partnerships and Outsourcing in Clinical Trials (2)
LIVE PANEL with Q&A: Regulatory challenges for clinical trials
- Maren von Fritschen - Regulatory Affairs, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Belgium
- Kristof Van Quathem - Senior Privacy and Technology Lawyer, Covington & Burling LLP, Belgium
- Sol Yates - Associate Director, Global Regulatory Affairs, Grünenthal GmbH, Germany
- Corrette Ploem - Associated Professor, University Medical Centre (UMC) Amsterdam, Netherlands
12:45 - 13:2540 mins
Operations in Clinical Trials (1)
LIVE PANEL with Q&A: Ensuring a good recruitment strategy - How to successfully recruit patients?
- Diana Sims-Silbermann - Specialist General and Emergency Medicine, Anesthesie, SeniorTrial Manager, Early Development and Clinical Pharmacology, Janssen-Cilag GmbH, Johnson & Johnson, Germany
- Philipp Badorrek - Head of Department, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Germany
- Olivia Barnes - Senior Research Nurse, Sherbourne Medical Centre, UK
- Estrella Garcia - Director Global Clinical Operations, Global Clinical Operations – R&D, Almirall, Spain
12:45 - 13:2540 mins
Operations in Clinical Trials (2)
LIVE PANEL with Q&A: Ensuring a good recruitment strategy - How to successfully recruit patients?
- Diana Sims-Silbermann - Specialist General and Emergency Medicine, Anesthesie, SeniorTrial Manager, Early Development and Clinical Pharmacology, Janssen-Cilag GmbH, Johnson & Johnson, Germany
- Philipp Badorrek - Head of Department, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Germany
- Olivia Barnes - Senior Research Nurse, Sherbourne Medical Centre, UK
- Estrella Garcia - Director Global Clinical Operations, Global Clinical Operations – R&D, Almirall, Spain
12:45 - 13:2540 mins
Technology in Clinical Trials (1)
LIVE PANEL with Q&A: Interaction between all stakeholders on decentralized/hybrid trials
- Maria Kuthning - Global Clinical Operations Lead, Boehringer Ingelheim, Germany
- Birgitte Denlow - GCP Advisor Specialist, Global Clinical Quality & Intelligence, Novo Nordisk, Denmark
- Jennifer Goldsack - Executive Director, Digital Medicine Society (DiMe), USA
12:45 - 13:2540 mins
Technology in Clinical Trials (2): Artificial Intelligence
LIVE PANEL with Q&A: Interaction between all stakeholders on decentralized/hybrid trials
- Maria Kuthning - Global Clinical Operations Lead, Boehringer Ingelheim, Germany
- Birgitte Denlow - GCP Advisor Specialist, Global Clinical Quality & Intelligence, Novo Nordisk, Denmark
- Jennifer Goldsack - Executive Director, Digital Medicine Society (DiMe), USA
13:25 - 14:2560 mins
Networking
LIVE Networking Forum
13:25 - 13:5530 mins
Tech Tour
Content Hub: Available
14:25 - 14:4520 mins
Partnerships and Outsourcing in Clinical Trials (1)
Embedding quality holistically: How do quality risk management and risk based monitoring work together?
- Michael Walega - Director, Centralized Monitoring, Global Data Management & Centralized Monitoring, BMS, USA
14:25 - 14:4520 mins
Partnerships and Outsourcing in Clinical Trials (2)
European Medical Device Regulation - May 2021- what will be the requirements?
- Nurcan Coskun - Global Risk Based Monitoring & Technology Solutions Program Manager, Formerly Medtronic, Switzerland
14:25 - 14:4520 mins
Operations in Clinical Trials (1)
Patient Engagement- Site selection and recruitment- from a site perspective
- Graeme Boyle - Senior R&D Manager, Tayside Medical Science Centre (TASC), UK
14:25 - 14:4520 mins
Operations in Clinical Trials (2)
The Patient Centricity Effect – How it benefits Patients, Sites and Sponsors – Practical cases from paediatric studies
- Mariangela Lupo - Communication and Patient Advocacy Manager, TEDDY European Network of Excellence for Paediatric Research, Italy
14:25 - 14:4520 mins
Technology in Clinical Trials (1)
How digital health technology will shape the trials of 2030
- Pamela Tenaerts - Executive Director, Clinical Trials Transformation Initiative (CTTI), USA
14:25 - 14:4520 mins
Technology in Clinical Trials (2): Artificial Intelligence
What’s really needed to transform information flow in clinical development
- Todd Georgieff - Global Consortia Program Lead, Genentech and Roche, Canada
14:45 - 15:0520 mins
Partnerships and Outsourcing in Clinical Trials (1)
The Suppliers perspective- What makes a good sponsor?
- Willie Muehlhausen - Managing Director/Founder, Muehlhausen Ltd, Ireland
14:45 - 15:0520 mins
Partnerships and Outsourcing in Clinical Trials (2)
Covid-19 related impact on drug development in the EU?
- Maren von Fritschen - Regulatory Affairs, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Belgium
14:45 - 15:0520 mins
Operations in Clinical Trials (1)
The importance of giving feedback to patients and results about the transparency of the clinical work
- Amelia Hursey - Research Participation Lead, Parkinson’s UK
14:45 - 15:0520 mins
Operations in Clinical Trials (2)
Pilot study/simulation using paediatric patients input in clinical trial development
- Joana Claverol - Clinical Research Unit Manager, Barcelona Children’s Hospital Sant Joan de Déu, Spain
- Begonya Nafria Escalera - Patient Engagement in Research Coordinator, Barcelona Children’s Hospital Sant Joan de Déu, Spain
14:45 - 15:0520 mins
Technology in Clinical Trials (1)
Spotlight Presentation: Taking a people-first approach to decentralized trials technology
- Bruce Hellman - CEO, Umotif
14:45 - 15:0520 mins
Technology in Clinical Trials (2): Artificial Intelligence
Regulatory challenges of using of new technologies in clinical trials
- Michel Arnoult - Chairman, Arnoult.org, France
15:05 - 15:2520 mins
Partnerships and Outsourcing in Clinical Trials (1)
Spotlight Presentation: Available
15:05 - 15:2520 mins
Partnerships and Outsourcing in Clinical Trials (2)
Regulatory expectations of working with audit
- Jennifer Nielsen - Process Development Specialist, Novo Nordisk AS, Denmark
15:05 - 15:2520 mins
Operations in Clinical Trials (1)
Spotlight Presentation: Syneos
15:05 - 15:2520 mins
Operations in Clinical Trials (2)
Spotlight Presentation: Available
15:05 - 15:2520 mins
Technology in Clinical Trials (1)
Spotlight Presentation: Learnings from a paediatric decentralised clinical trial
- Helen Todman - Associate Project Director, Parexel International, UK
15:05 - 15:2520 mins
Technology in Clinical Trials (2): Artificial Intelligence
Spotlight Presentation: Available
15:25 - 16:2560 mins
LIVE Networking Reception
16:25 - 16:3510 mins
End of Day Two
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