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DAY TWO - CET/CEST (Cent Europe Summer, GMT+2)
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DAY TWO - CET/CEST (Cent Europe Summer, GMT+2)
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09:25 - 09:5530 mins
Start your Day with Yoga and Relaxation
09:55 - 10:005 mins
Your Event Experience - Platform Tutorial
- Louisa Maitland - Conference Director, Informa, UK
10:00 - 10:055 mins
Welcome to Day Two of Clinical Trials Europe from the Conference Director
- Louisa Maitland - Conference Director, Informa, UK
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)
Collaborative working from the very start –view from a primary care site perspective
- Olivia Barnes - Senior Research Nurse, Sherbourne Medical Centre, UK
10:05 - 10:2520 mins
Technology in Clinical Trials (1)
Remote informed consent and reconsents: A critical building block for your unique DCT strategy
- Rasmus Hogreffe - VP, Decentralized Clinical Trial Innovation, Medable, USA
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 - 10:5530 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 Burden of the Clinical Research Bureaucracy on the Patient Experience
- Natacha Bolaños - EHA EAC Member on behalf of the Hematology Patient Community, Lymphoma Coalition, Spain
10:25 - 10:4520 mins
Operations in Clinical Trials (2)
eCOA setup: How to ensure a successful launch by navigating complexities
- Estelle Haenel - Medical Director, Kayentis, France
10:25 - 10:4520 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
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)
Conducting clinical trials during the COVID-19 pandemic
- Mariska Beukers - Director Project Management, QPS, The Netherlands
10:45 - 11:0520 mins
Operations in Clinical Trials (1)
Innovative trial design during COVID-19
- Catherine Hall - VP of Product Strategy, endpoint Clinical, USA
10:45 - 11:0520 mins
Operations in Clinical Trials (2)
Setting up COVID-19 clinical trials during the pandemic
- Dominiek Staelens - International Project Manager, SGS Life Sciences, Belgium
10:45 - 11:0520 mins
Technology in Clinical Trials (1)
Spotlight Presentation: PRA
- Alexandre Malouvier - Director Global Data Strategy, PRA Health Sciences, France
10:45 - 11:0520 mins
Technology in Clinical Trials (2): Artificial Intelligence
The power of big data, cloud computing, and AI to transform clinical trials
- Prakriteswar Santikary - Vice President, Chief Data Officer, ERT, USA
11:05 - 12:0560 mins
Networking
LIVE Showcase Hub Networking
11:05 - 11:105 mins
Tech Tour
Tech Tour: Parexel
- Rosamund Round - Vice President, Patient Innovation Center, Parexel International, UK
11:10 - 11:155 mins
Tech Tour
Tech Tour: Medable
- Alison Holland - Head of Decentralized and Remote trials, Medable, UK
11:15 - 11:205 mins
Tech Tour
Tech Tour: Trilogy Writing and Consulting
11:20 - 11:255 mins
Tech Tour
Tech Tour- Signant Health
12:05 - 12:2520 mins
Partnerships and Outsourcing in Clinical Trials (1)
About 'controllers' and 'processors' in clinical research
- Corrette Ploem - Associated Professor, University Medical Centre (UMC) Amsterdam, Netherlands
- Astrid van der Zanden - Senior Legal Staff Member, Central Committee on Research Involving Human Subjects (CCMO), The Netherlands
12:05 - 12:2520 mins
Partnerships and Outsourcing in Clinical Trials (2)
About 'controllers' and 'processors' in clinical research
- Corrette Ploem - Associated Professor, University Medical Centre (UMC) Amsterdam, Netherlands
- Astrid van der Zanden - Senior Legal Staff Member, Central Committee on Research Involving Human Subjects (CCMO), The Netherlands
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)
Advancements in patient centricity during 2020
- Stephen Nabarro - Head of Clinical Operations and Data Management, Cancer Research UK Centre for Drug Development
12:05 - 12:2520 mins
Technology in Clinical Trials (1)
Decentralized clinical trials – The strategic approach
- Todd McGrath - Vice President of Project Management and Head of US and Oceania, Medical Research Network, USA
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)
Partnerships in the Pandemic: Deploying eConsent for Remote and Hybrid Studies
- Karen Maduschke - Senior Director & General Manager, IQVIA Technologies, Germany
12:25 - 12:4520 mins
Partnerships and Outsourcing in Clinical Trials (2)
Partnerships in the Pandemic: Deploying eConsent for Remote and Hybrid Studies
- Karen Maduschke - Senior Director & General Manager, IQVIA Technologies, Germany
12:25 - 12:4520 mins
Operations in Clinical Trials (1)
Clinical trial technology in the time of COVID-19
- Faisal Shahzad - Project Manager (EU), Greenphire, UK
- Zach Hales - Product Manager (US), Greenphire, USA
12:25 - 12:4520 mins
Operations in Clinical Trials (2)
The patient experience in gathering new data to support Real World Evidence
- Matthew McCarty - Vice President, Digital Patient, ERT, UK
12:25 - 12:4520 mins
Technology in Clinical Trials (1)
Enabling true patient centricity through smart medication
- Hilde Vanaken - Senior Industry Advisor, TCS Life Sciences and Healthcare, Belgium
12:25 - 12:4520 mins
Technology in Clinical Trials (2): Artificial Intelligence
Best practices for trial data collaboration across sites, CROs, sponsors, and regulators
- Dr Alok Tayi - VP of Life Sciences, Egnyte, USA
12:45 - 13:4560 mins
Partnerships and Outsourcing in Clinical Trials (1)
LIVE Panel, Q&A and Audience Interaction: Juggling Regulatory Challenges for Clinical Trials in the Covid-19 era – Can we make it work?
- Cécile Ollivier - Chief Innovation and Regulatory Science Officer, Aparito, The Netherlands
- Kristof Van Quathem - Senior Privacy and Technology Lawyer, Covington & Burling LLP, Belgium
- Sol Yates - Associate Director, Global Regulatory Affairs, Grünenthal GmbH, Germany
- Julianne Hull - CEO, WenStar Enterprizes
12:45 - 13:4560 mins
Partnerships and Outsourcing in Clinical Trials (2)
LIVE Panel, Q&A and Audience Interaction: Juggling Regulatory challenges for Clinical Trials in the Covid-19 era – Can we make it work?
- Cécile Ollivier - Chief Innovation and Regulatory Science Officer, Aparito, The Netherlands
- Kristof Van Quathem - Senior Privacy and Technology Lawyer, Covington & Burling LLP, Belgium
- Sol Yates - Associate Director, Global Regulatory Affairs, Grünenthal GmbH, Germany
- Julianne Hull - CEO, WenStar Enterprizes
12:45 - 13:4560 mins
Operations in Clinical Trials (1)
LIVE Panel, Q&A and Audience Interaction: 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
- Amelia Hursey - Research Participation Lead, Parkinson’s UK
12:45 - 13:4560 mins
Operations in Clinical Trials (2)
LIVE Panel, Q&A and Audience Interaction: 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
- Amelia Hursey - Research Participation Lead, Parkinson’s UK
12:45 - 13:4560 mins
Technology in Clinical Trials (1)
LIVE Panel, Q&A and Audience Interaction: Interaction between all stakeholders on decentralized/hybrid trials
- Maria Kuthning - Executive Global Clinical Operations - Digital Transformation, Formerly Johnson & Johnson, Germany
- Birgitte Denlow - GCP Advisor Specialist, Global Clinical Quality & Intelligence, Novo Nordisk, Denmark
- Jennifer Goldsack - Executive Director, Digital Medicine Society (DiMe), USA
- Matthew Bonam - Head of R&D Digital, AstraZeneca R&D
- Zach Hales - Product Manager (US), Greenphire, USA
- Rasmus Hogreffe - VP, Decentralized Clinical Trial Innovation, Medable, USA
- Ahmed Albaiti - CEO and Founder, Medullan, USA
12:45 - 13:4560 mins
Technology in Clinical Trials (2): Artificial Intelligence
LIVE Panel, Q&A and Audience Interaction: Interaction between all stakeholders on decentralized/hybrid trials
- Maria Kuthning - Executive Global Clinical Operations - Digital Transformation, Formerly Johnson & Johnson, Germany
- Birgitte Denlow - GCP Advisor Specialist, Global Clinical Quality & Intelligence, Novo Nordisk, Denmark
- Jennifer Goldsack - Executive Director, Digital Medicine Society (DiMe), USA
- Matthew Bonam - Head of R&D Digital, AstraZeneca R&D
- Zach Hales - Product Manager (US), Greenphire, USA
- Rasmus Hogreffe - VP, Decentralized Clinical Trial Innovation, Medable, USA
- Ahmed Albaiti - CEO and Founder, Medullan, USA
13:45 - 14:4560 mins
Networking
LIVE Showcase Hub Networking plus Visit the Digital Caricature sponsored by Covance
13:45 - 13:505 mins
Tech Tour
Tech Tour: ClinScience
13:50 - 13:555 mins
Tech Tour
Tech Tour- SGS
13:55 - 14:005 mins
Tech Tour
Tech Tour - Tata Consultancy Services
14:00 - 14:055 mins
Tech Tour
Tech Tour-uMotif
14:45 - 15:0520 mins
Partnerships and Outsourcing in Clinical Trials (1)
European Medical Device Regulation - May 2021- what will be the requirements?
- Nurcan Coskun - Global Risk Based Monitoring & Technology Solutions Program Manager, Formerly Medtronic, Switzerland
14:45 - 15:0520 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
14:45 - 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)
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
14:45 - 15:0520 mins
Technology in Clinical Trials (1)
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
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
15:05 - 15:2520 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
15:05 - 15:2520 mins
Partnerships and Outsourcing in Clinical Trials (2)
Quantifying participant diversity in clinical trials
- Kenneth Getz - Deputy Director and Professor, Tufts Center for the Study of Drug Development Tufts University, USA
15:05 - 15:2520 mins
Operations in Clinical Trials (1)
Regulator’s perspective for complex clinical trials and innovative trial designs
- Maria Beatrice Panico - Senior Medical Assessor, Clinical Trials Unit, Medicines and Healthcare Products Regulatory Agency, UK
15:05 - 15:2520 mins
Operations in Clinical Trials (2)
Regulator’s perspective for complex clinical trials and innovative trial designs
- Maria Beatrice Panico - Senior Medical Assessor, Clinical Trials Unit, Medicines and Healthcare Products Regulatory Agency, UK
15:05 - 15:2520 mins
Technology in Clinical Trials (1)
Taking a people-first approach to decentralized trials technology
- Bruce Hellman - CEO, uMotif, UK
15:05 - 15:2520 mins
Technology in Clinical Trials (2): Artificial Intelligence
Taking a people-first approach to decentralized trials technology
- Bruce Hellman - CEO, uMotif, UK
15:25 - 15:4520 mins
Partnerships and Outsourcing in Clinical Trials (1)
Managing complexity: COVID-19 road to recovery
- Graham Ilsley - Vice President & Head Global Clinical Delivery, Covance, UK
- Monica Malcarne - Site Head, Senior Director Operations and Board President, Covance
- Oren Cohen - Chief Medical Officer and Head of Global Clinical Pharmacology Services, Covance, USA
15:25 - 15:4520 mins
Partnerships and Outsourcing in Clinical Trials (2)
Managing complexity: COVID-19 road to recovery
- Graham Ilsley - Vice President & Head Global Clinical Delivery, Covance, UK
- Monica Malcarne - Site Head, Senior Director Operations and Board President, Covance
- Oren Cohen - Chief Medical Officer and Head of Global Clinical Pharmacology Services, Covance, USA
15:25 - 15:4520 mins
Operations in Clinical Trials (1)
Optimizing oncology trial design and delivery
- Spencer Kalk - Project Director, Associate Project Director, Oncology and Hematology Business Unit, Syneos, USA
15:25 - 15:4520 mins
Operations in Clinical Trials (2)
Accelerating paediatric development with technology
- Cécile Ollivier - Chief Innovation and Regulatory Science Officer, Aparito, The Netherlands
15:25 - 15:4520 mins
Technology in Clinical Trials (1)
Learnings from a paediatric decentralised clinical trial
- Helen Todman - Project Director, Parexel International, UK
15:25 - 15:4520 mins
Technology in Clinical Trials (2): Artificial Intelligence
Learnings from a paediatric decentralised clinical trial
- Helen Todman - Project Director, Parexel International, UK
15:45 - 16:3045 mins
LIVE Networking Activity: Clinical Trials Europe Quiz Sponsored by Covance
16:30 - 16:355 mins
End of Day Two
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