Sorting Medicine

Programme

Chair of the day: Dr. Marjon Pasmooij, Science programme manager Medicines Evaluation Board

13.00 – 13.05

Opening

Dr. Marjon Pasmooij, Science programme manager Medicines Evaluation Board

13.05 – 13.10

Welcome

Prof. Ton de Boer, chair Medicines Evaluation Board

13.10 – 13.40

Projections from the past

Prof. Bruno Stricker, Professor Pharmaco-epidemiology, Erasmus Medical Centre Rotterdam

13.40 – 14.10

The nature of signals

Prof. Eugène van Puijenbroek, Head Science and Research at the Netherlands Pharmacovigilance Centre and Professor of Pharmacovigilance at University Groningen

14.10 – 14.40

Pharmacovigilance : looking towards the future

Dr. Sabine Straus, Chair Pharmacovigilance Risk Assessment Committee of the European Medicines Agency 

14.40 – 14.55

Coffee and Tea Break 

14.55 – 15.15

PhD session 1

1. Pharmacovigilance of biologicals - “Regulatory safety learning driven by the mechanism of action: the case of TNF-α inhibitors” – Lotte Minnema

2. Risk minimisation measures - “Introduction or discontinuation of additional Risk Minimalisation Measures during the life cycle of medicines in Europe” – Remy Francisca

3. Regulatory learning - “Post-approval regulatory learning about benefits and risks” – Lourens Bloem

4. Risk communication - “Handling of new drug safety information in the Dutch hospital setting” – Esther de Vries

5. Exposure to biologicals during pregnancy/lactation - “Validation of biologics continuation during pregnancy by analyzing concentrations in cord blood” – 
Nafise Ghalandari

15.20 – 15.40

PhD session 2

1. Pharmacovigilance of biologicals - “Regulatory safety learning driven by the mechanism of action: the case of TNF-α inhibitors” – Lotte Minnema

2. Risk minimisation measures - “Introduction or discontinuation of additional Risk Minimalisation Measures during the life cycle of medicines in Europe” – Remy Francisca

3. Regulatory learning - “Post-approval regulatory learning about benefits and risks” – Lourens Bloem

4. Risk communication - “Handling of new drug safety information in the Dutch hospital setting” – Esther de Vries

5. Exposure to biologicals during pregnancy/lactation - “Validation of biologics continuation periods during pregnancy by analyzing concentrations in cord blood” – 
Nafise Ghalandari

15.40 – 15.45

Coffee and Tea Break 

15.45 – 16.15

Panel discussion

Facilitator: Dr. Marjon Pasmooij, Science programme manager MEB
Panel: Prof. Bruno Stricker, Prof. Eugène van Puijenbroek and Dr. Sabine Straus

16.15 – 16.30

Reflections on the day
Prof. dr. Ton de Boer, chair Medicines Evaluation Board

 

Keynote speakers

Dr. Marjon Pasmooij

Prof. Ton de Boer

Prof. Bruno Stricker

Prof. Eugène van Puijenbroek

Dr. Sabine Straus

 

PhD Speakers

 

For questions or contact information, send an email to: science@cbg-meb.nl

2020 - Medicines Evaluation Board | evisit.nl