3rd EUFEMED Conference

28-30 April 2021 - virtual and interactive

Exploratory Development of Novel Therapeutic Approaches

Focused strategies based on lessons learned in the pandemic

PRELIMINARY PROGRAMME

Version February 2021

During the afternoon attendees including exhibitors can book hop-in rooms for small groups or one-on-one discussions

Day 1, Wednesday, 28 April 2021

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

Day 2, Thursday, 29 April 2021

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; Oliver Galm, Germany; Bettina Ziegele (PEI), Germany 

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; Oliver Galm, Germany; Bettina Ziegele (PEI), Germany 

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

Day 3, Friday, 30 April 2021

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

Conference days