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Meeting Co-chairs: Gabriele Dallmann and John Purves

DAY 1: Thursday, 27 February 2014

10.00 - 11.00 Registration and welcome coffee
11.00 - 11.15 Welcome to the meeting

Session 1: Roundup of the last year on regulatory activities in Europe and the US

11.15 - 12.15

News and trends in Europe: update of EMA activities including the Biosimilar Medicinal Product Working Party (BMWP) and Committee of Advanced Therapies (CAT) activities
Christian Schneider (BMWP and CAT Chairman, Danish Health and Medicines Authority), Anne Cook (MHRA)

12.15 - 12.35

Optimising regulatory pathways - Roche examples
Andrea Braun-Scherhag (Roche)

12.35 - 13.00
EMA contributions to facilitate innovation: current state of discussion
Jan Müller-Berghaus (Paul-Ehrlich-Institut)
13.00 - 14.00


14.00 - 15.00

News and trends in the US: update of FDA activities
including the status of the FDA draft guidance on biosimilar product development
Steven Kozlowski (FDA) (per remote video presentation)

15.00 - 15.15

The EMA-FDA biosimilar cluster
Christian Schneider (Danish Health and Medicines Authority) and Steven Kozlowski (FDA)

15.15 - 15.45

Session 1 panel discussion, chaired by meeting co-chairs
Featuring: Christian Schneider (CAT Chairman, Danish Health and Medicines Authority), Jan Müller-Berghaus (Paul-Ehrlich-Institut), Steven Kozlowski (FDA), Ilona Reischl (AGES), Anne Cook (MHRA), Andrea Braun-Scherhag (Roche)

15.45 - 16.15 Coffee Break

Session 2: Biosimilar monoclonal antibodies: their way to the market

16.15 – 17.00

Case study: the approval of the first biosimilar monoclonal antibody
Anne Cook (MHRA) and Jan Müller-Berghaus (Paul-Ehrlich-Institut)

17.00 - 17.30

Thoughts on the value of clinical trials to demonstrate similarity:
what is their role in the overall similarity package and what do they show us
Jan Müller-Berghaus (Paul-Ehrlich-Institut)

17.30 - 18.00

Session 2 panel discussion, chaired by meeting co-chairs
Featuring: Anne Cook (MHRA), Jan Müller-Berghaus (Paul-Ehrlich-Institut),
Christian Schneider (Danish Health and Medicines Authority)

18.00 Close of day one
19.00 Social event

DAY 2: Friday, 28 February 2014

08.00 - 08.30 Welcome coffee with snacks

Session 3: Update on the Clinical Trial Regulation and the PRAC activities

08.30 - 09.00

Clinical trials in the EU: where do we stand with the update of the clinical trial regulations
Ilona Reischl (AGES)

09.00 - 09.30

Practical implications including transparency initiative
Ilona Reischl (AGES)

09.30 - 10.00 Coffee Break
10.00 - 10.45

Pharmacovigilance in the EU with emphasis on biopharmaceuticals – PRAC activities update
Sabine Straus (CBG-MEB)

10.45 - 11.15

Session 3 panel discussion, chaired by meeting co-chairs
Featuring: Ilona Reischl (AGES), Sabine Straus (CBG-MEB), Andrea Braun-Scherhag (Roche), Judith Creba (Novartis)

Session 4: Science and strategy of development

11.15 - 11.45

Experience with the pilot EMA-HTA joint scientific advice
Judith Creba (Novartis)

11.45 - 12.15 Break with refreshments and snacks
12.15 - 13.00

Does innovation reach authorities: trends in scientific advice and review procedures: trends towards more Phase II studies, dose finding for biopharmaceuticals - novel Modelling and Simulation Group, devices in ATMP
Jens Reinhardt (Paul-Ehrlich-Institut)

13.00 - 13.30

Is the legal pathway ready to regulate drug-diagnostic companion developments?
Genevieve Michaux (Hunton & Williams)

13.30 - 14.00

Session 4 panel discussion, chaired by meeting co-chairs
Featuring: Genevieve Michaux (Hunton & Williams), Jens Reinhardt (Paul-Ehrlich-Institut), Judith Creba (Novartis),
Andrea Braun-Scherhag (Roche), Jan Müller-Berghaus (Paul-Ehrlich-Institut)


Wrap up and concluding remarks



Close of meeting

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