The health emergency: regulatory crash and future perspectives
This past year we have witnessed unprecedented responses to the COVID-19 emergency that led the scientific community to an unparalleled mobilisation and sharing of information between researchers, companies, regulators, healthcare professionals, patient representatives and public health bodies. This resulted in the approval of several vaccines and medicines against this new disease to get the pandemic under control.
The XIV Foresight Training Course (FTC) “The health emergency: regulatory crash and future perspectives” will run virtually on December 10th, 2021 at 11.15am (CET).
In particular, the first session of the event will be focused on the extraordinary regulatory measures put in place by the international and national authorities to face the emergency, the lessons learnt from the pandemic and their impact on future actions that might improve the healthcare system in Europe.
The European Medicines Agency (EMA) adapted its assessment procedures, by using the rolling review process, to achieve the authorisation of safe and effective treatments and vaccines for COVID-19 within the shortest possible time frame, as well as a rapid scientific advice procedure has been put in place.
In addition, conditional marketing authorisations have been granted by the European Commission (EC) to expedite the approval of treatments and vaccines, on the basis of available evidence as soon as it became available from ongoing studies.
Several challenges occurred in the clinical practice as well as in the conduct of clinical trials due to limitations in the access to healthcare facilities and trial staff availability. The Guidance on the management of clinical trials during the COVID-19 pandemic has been published in February 2021.
In this framework the use of innovative digital technologies, such as Electronic Medical Records, Health Apps and other medical devices, collecting health data regularly, has been widely enhanced. This can support the management and monitoring not only of COVID-19 patients but also other diseases. An insight on the value of the use and sharing of health data will be provided in the second and third sessions of the course.
What is left of all these changes? How will they influence the future?
Feel free to raise your questions to speakers in advance using the Slido link here.
AGENDA (CET TIME)
11:15
Welcome
Fedele Bonifazi, Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
11:20
Introductory remarks
Maurizia Dossena & Enrico Bosone
Session 1 – How the European regulatory framework reacted to the COVID-19 emergency:
extraordinary and challenging measures
Chairs – Viviana Giannuzzi & Vincenzo Salvatore
11:30
Regulatory process in the COVID-19 era: how to deal with the organisational and scientific challenges at the European Medicines Agency level?
Fergus Sweeney, Clinical Studies and Manufacturing Task Force, European Medicines Agency
11:50
Clinical research after the COVID-19 era: the current scenario and the upcoming application
of the Clinical Trials Regulation
Martine Dehlinger-Kremer, ICON Plc & European CRO Federation (EUCROF)
12:10
Decentralized Clinical Trials: strengths and weaknesses of safety management
Maria Grazia Felisi, Consorzio per Valutazioni Biologiche e Farmacologiche
12:30
The opportunity of decentralized Clinical Trials in rare diseases: the PRONTO study
Stefano Portolano, Azafaros
12:50
Strengths and weaknesses of General Data Protection Regulation implementation for
paediatric research
Annagrazia Altavilla, Espace Ethique PACA-Corse/AP-HM
13:10
Panel discussion
13:20
Break
Session 2 – Connecting and sharing health data: the repurposing approach
Chairs – Fedele Bonifazi & Marek Migdal
14:00
The therapeutic value of drug repurposing and repositioning
Oscar Della Pasqua, University College London
14:20
Data Space and Regulatory Decision making
Ine Skottheim Rusten, The Norwegian Medicines Agency
14:40
Artificial Intelligence tool to predict drug efficacy and safety profile
Aris Persidis, Biovista
15:00
Health data collection and FAIRification
Marco Roos, Leiden University Medical Centre
15:20
Panel discussion
15:30
Break
Session 3 – The power of data sharing to enhance evidence for innovative treatments
Chairs – Enrico Bosone & Paola Baiardi
15:40
Federated learning as a tool for gathering knowledge from multiple data sources
George Drosatos, Athena Research and Innovation Centre
16:00
European Reference Networks and patients’ registries initiative
Maurizio Scarpa, European Reference Network for Hereditary Metabolic Disorders – MetabERN
16:20
The Duchenne Data Platform
Nawel van Lin, Center for Molecular and Biomolecular Informatics, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center
16:40
Real-World Evidence Data in a Drug Submission Process: the EMA vs. FDA perspective
Luca Pani, University of Miami
17:00
Panel discussion
17:10
Collaborative networks against COVID-19: Lessons learned from LEOSS, NAPKON, ORCHESTRA
Jörg Janne Vehreschild, University Hospital of Cologne
17:30
Real use of real-world data
Fedele Bonifazi, Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
17:50
Panel discussion
18:00
Final remarks
Adriana Ceci & Viviana Giannuzzi
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Course Scientific Committee
Adriana Ceci | Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
Enrico Bosone | Società Italiana Attività Regolatorie
Fedele Bonifazi | Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
Viviana Giannuzzi | Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
Organised by
Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
