3rd EUFEMED Conference
28-30 April 2021 - virtual and interactive
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Exploratory Development of Novel Therapeutic Approaches
Focused strategies based on lessons learned in the pandemic
28-30 April 2021 - virtual and interactive
Exploratory Development of Novel Therapeutic Approaches
Focused strategies based on lessons learned in the pandemic
Version February 2021
During the afternoon attendees including exhibitors can book hop-in rooms for small groups or one-on-one discussions
12:30
Dial-in open
12:45
Welcome by the President
Yves Donazzolo, France
12:50
Meet and greet of attendees and exhibitors at the virtual exhibition
Session 1
13:15-15:15
How to better prepare European early medicines development for future pandemics
Chairs: Yves Donazzolo, France; Tim Hardman, United Kingdom
13:15
Keynote Lecture
Drug discovery and early development strategies for prevention and treatment of virus infections (including repurposing)
Johan Neyts, Belgium
13:45
Innovative EU marketing authorisation strategies in times of a pandemic
Jordi Llinares Garcia (EMA), The Netherlands
14:15
The role of early phase data in the UK approach to market authorisation for SARS-CoV-2 vaccines
Kirsty Wydenbach (MHRA), United Kingdom
14:45
Panel and Open Forum discussion with speakers and the audience
15:15
Break and Networking in the virtual exhibition
Session 2
16:00-17:30
Technology support to reduce the risks of pandemic effects on Phase1/2 trial performance
Chairs: Henri Caplain, France; Jorg Taubel, United Kingdom
16:00
Technologies in trial conduct (including tracing, testing, remote technologies for trials)
Elin Haf Davies, United Kingdom
16:30
Covid-19 the tipping point in GCP: From reactive to prospective and proactive quality and compliance management
Beat Widler, Switzerland
17:00
Panel and Open Forum discussion with speakers and audience
12:30
Dial-in open
12:45
Introduction into the day’s programme
Moderator: Hildegard Sourgens, Germany
This Conference Day is dedicated to getting updates from researchers and service providers on particularly relevant innovations in early medicines development and on exchange of own experiences with colleagues in parallel sessions.
from 13:00
Parallel track: scientific and methodology presentations from exhibitors
13:00-14:30
Parallel interactive Break-out Sessions, Round 1
Room 1
Benefit-risk evaluation in ATMP trials – aspects of short- term benefits and
long-term risks
Henri Caplain, France;Â Oliver Galm, Germany; Bettina Ziegele (PEI), GermanyÂ
Room 2
How will working and training change after the COVID-19 experiences with travel and meeting restrictions?
Kerstin Breithaupt-Grögler, Germany; Tim Hardman, United Kingdom
Room 3
Early phase clinical trials under the Clinical Trials Regulation
Yves Donazzolo, France; Barbara Schug, Germany; Thomas Sudhop (BfArM), Germany
Room 4
CanSino vaccine: SARS-CoV-2 vaccine development experiences
Ayad Abdul-Ahad, United Kingdom; Dmitry Lioznov, Russia
14:30
Break and Networking in the virtual exhibition
Session 3
14:50-15:35
Poster Presentations
Chairs: Kerstin Breithaupt-Grögler, Germany; Jan de Hoon, Belgium
Eric Mannaert, Belgium; Jens Rengelshausen, Germany
14:50
Parallel sessions with poster presentations and discussions
(Participants can pick and choose which poster session they would like to attend and
hop between sessions)
15:35
Break and Networking in the virtual exhibition
16:00-17:30
Parallel interactive Break-out Sessions, Round 2
Room 1
Benefit-risk evaluation in ATMP trials – aspects of short- term benefits and
long-term risks
Henri Caplain, France;Â Oliver Galm, Germany; Bettina Ziegele (PEI), GermanyÂ
Room 2
How will working and training change after the COVID-19 experiences with travel and meeting restrictions?
Kerstin Breithaupt-Grögler, Germany; Tim Hardman, United Kingdom
Room 3
Early phase clinical trials under the Clinical Trials Regulation
Yves Donazzolo, France; Barbara Schug, Germany; Thomas Sudhop (BfArM), Germany
Room 4
CanSino vaccine: SARS-CoV-2 vaccine development experiences
Ayad Abdul-Ahad, United Kingdom; Dmitry Lioznov, Russia
17:30
“Participants’ Apéro“ · Meet your colleagues and exhibitors virtually
12:30
Dial-in open
12:45
Introduction into the day’s programme
Moderator: Ingrid Klingmann, Belgium
12:50
OXFORD Debate
Do we really need placebo in single ascending dose studies?
Chair: Ingrid Klingmann, Belgium
Speakers: Peter Dewland; Sven Van Dijkman, United Kingdom
13:35
Break and Networking in the virtual exhibition
Session 4
13:55-15:20
Trends in clinical trial designs
Chairs: Jan de Hoon, Belgium; Andreas Kovar, Germany
13:55
How can extrapolation between populations
improve decision-making and speed-up early
phase development using biostatistics?
Alice Gosselin; Caroline Petit, France
14:25
Preclinical and early clinical design challenges in ATMP development
Diane Seimetz, Germany
14:55
SARS-CoV-2 viral challenge study in healthy volunteers
Christopher Chiu, United Kingdom
15:20
Break and Networking in the virtual exhibition
Session 5
15:40-17:30
Regulatory experiences with COVID-19 vaccine authorisations
Chairs: Joop van Gerven, The Netherlands and Kirsty Wydenbach, United Kingdom
15:40
Fast track clinical trial authorisation today and under the Clinical Trial Regulation
Greet Musch, Belgium
16:10
How to justify marketing authorisation with minimal early phase data only?
tba
16:40
Success and failures in early vaccine development, experience with COVID-19 vaccines
Michael Pfleiderer, Germany
17:10
Panel & Open Forum discussion with speakers and the audience
17:30
Closing remarks – Urgent next steps for better preparation?
New EUFEMED President
CSi Hamburg GmbH
GoernestraĂźe 30
20249 Hamburg (Germany)