MEDIA

EVENTS

XIII Foresight Training Course

Challenges for Researchers and Regulators facing the pandemic crisis

,
23/10/2020

The unprecedented COVID-19 emergency has had a huge impact on the whole society as well as on the prompt availability of effective medicines, questioning the Pharmaceutical System worldwide.

The Coronavirus pandemic clearly demonstrates the need to revise some of the cornerstones of the European Pharmaceutical System and of the drug development process in order to properly meet patients’ needs and ensure them timely access to medicines under all circumstances.

Annually, Fondazione Gianni Benzi organises the Foresight Training Course (FTC), a short international course aimed to promote pharmacological research and innovation. The pandemic has had an impact on our activities too, but we do not give up!

Therefore, this year, due to the restrictions enforced, the XIII FTC will run virtually and in a shorter version on 23 October 2020 at 09:30 AM (CEST). It will be focused on how the pandemic crisis forced the European Regulatory Pharmaceutical System to change.

We want to discuss the proposed European Union (EU) new strategy, just launched in the pandemic framework, that aims to improve and accelerate patients’ access to high-quality, safe and affordable medicines and to support further innovation in the European pharmaceutical industry.

The first session of the course will exactly address this new European strategy, giving way to the Health Authorities and Regulators as well as to different stakeholders involved in the announced revolution of the EU Pharmaceutical System.

Experts from companies, healthcare professionals, researchers and patients’ groups will share their contribution representing the key points to be discussed during the meeting.

Fondazione Benzi, that has always been actively committed in contributing to the regulatory debate, will gather all the considerations from stakeholders and will guide this process.

The EU pharmaceutical debate includes the proposal to revise two main EU Pharmaceutical System pillars: the Orphan Medicines Regulation and the Paediatric Regulation, that will be deeply considered in a dedicated window of the meeting in order to discuss possible improvement and administrative simplification without reducing their relevance for patients, companies and researchers.

 

Here below you can freely consult some useful material including highlights, presentations and recordings.
AGENDA

09:30 – 09:40
Introductory remarks
Adriana Ceci, Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus

Session 1 – The COVID-19 emergency and the European pharmaceutical system: strengths and weaknesses
Chairs Fedele Bonifazi & Vincenzo Salvatore

09:40 – 10:00
The new Pharmaceutical Strategy for Europe – Timely patient access to affordable medicines: key points and challenges
Fabio D’Atri, European Commission

10:00 – 10:20
The increased value of the EC consultation to promote the new strategy
Viviana Giannuzzi & Enrico Bosone on behalf of Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus

10:20 – 10:40
Company perspective
Ansgar Hebborn, La Roche AG

10:40 – 11:00
Patients’ perspective
François Houyez, EURORDIS

11:00 – 11:20
Q&A session

11:20 – 11:40
Coffee Break

Session 2 – COVID-19 accelerates research and development of new medicines and vaccines
Chairs Cosimo Altomare & Adriana Ceci

11:40 – 12:00
The EMA regulatory framework for timely approval of new and innovative drugs and vaccines in the pandemic era
Marco Cavaleri, European Medicines Agency

12:00 – 12:20
Company perspective
Martin F. Ryser, Janssen-Cilag SpA

12:20 – 12:40
Impact of COVID-19 on Clinical Trials. New approaches that can be taken for future trials
Martine Dehlinger-Kremer, EUCROF

12:40 – 13:00
Academia perspective
Andrea Gambotto, University of Pittsburgh School of Medicine

13:00 – 13:10
Q&A session

13:10 – 14:00
Break

Session 3 – Special insights on pharmaceutical R&D plans and rules in the framework of the pharmaceutical system reform
Chairs Fabio D’Atri & Paola Baiardi

14:00 – 14:30
Orphan Medicines Regulation faced with changes in EU and US pharmaceutical perspective
Viviana Giannuzzi, Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
Discussant: Violeta Stoyanova-Beninska, Committee for Orphan Medicinal Products at EMA

14:30 – 15:00
Strategic considerations regarding paediatric medicine development – Enpr-EMA reflections
Pirkko Lepola, European Network of Paediatric Research at the European Medicines Agency
Discussant: Donato Bonifazi, European Paediatric Translational Research Infrastructure – EPTRI

15:00 – 15:30
Research and innovation for new and advanced medicines: the role of Artificial Intelligence
Francesca Mazzi, Queen Mary University of London
Discussant: Fedele Bonifazi, Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus

15:30 – 15:50
Ethical concerns and risks in health emergency: patients protection and fundamental rights
Annagrazia Altavilla, Espace Ethique PACA-Corse/AP-HM

15:50 – 16:10
Discussion and final remarks

Speakers' list

Download the speakers’ list here.

Highlights

Highlights are brief reports that refer the key points of the topics discussed by each speaker. 

Session I

Session II

Session III

Q&A Session

Please fill the form below to access to the material including speaker’s presentations shared during the webinar and recordings.

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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
      Salvatore Vincenzo | Università di Insubria
      Annagrazia Altavilla | Espace Ethique PACA-Corse/AP-HM
      Viviana Giannuzzi | Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus

      Organised by

      Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus

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