European Medicines Agency (EMA)/European Generic medicines Association joint workshop on the impact of the revised EMA guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms
Date:
30/04/2015
Location:
European Medicines Agency, London, UK
The workshop provides a platform to discuss the impact of the revised European Medicines Agency guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms. It aims at fostering a common understanding and interpretation of regulatory expectations before 1 June 2015, when the guideline comes into effect.
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Programme of the European Medicines Agency (EMA)/European Generic medicines Association joint workshop on the impact of the revised EMA guideline on the pharmacokinetic and clinical evaluation of modified-release dosage ... (PDF/162.47 KB)
First published: 16/03/2015
Last updated: 30/04/2015
EMA/157739/2015 -
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Presentation - EMA/EGA workshop - Session 1: Orally Administered Modified Release Products (Gerald Beuerle) (PDF/198.71 KB)
First published: 04/05/2015
Last updated: 04/05/2015 -
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Presentation - EMA/EGA workshop - Session 1: Orally administered Modified Release Products - European Regulatory Requirements (Henrike Potthast) (PDF/1.2 MB)
First published: 04/05/2015
Last updated: 04/05/2015 -
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Presentation - EMA/EGA workshop - Session 2 :Injectable Modified Release Products (Yu Chung Tsang) (PDF/105.48 KB)
First published: 04/05/2015
Last updated: 04/05/2015 -
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Presentation - EMA/EGA workshop - Session 2: Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms - Injectable modified release products (Sotiris Michaleas) (PDF/454.54 KB)
First published: 04/05/2015
Last updated: 04/05/2015 -
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Presentation - EMA/EGA workshop - Session 3: Transdermal Products (PK + Adhesion + Irritation/Sensitization) (Bjà¶rn Schurad) (PDF/172.46 KB)
First published: 04/05/2015
Last updated: 04/05/2015 -
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Presentation - EMA/EGA workshop - Session 3: TDDS and Appendix I + II (Jan Neuhauser) (PDF/807.08 KB)
First published: 04/05/2015
Last updated: 04/05/2015 -
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Presentation - EMA/EGA workshop - Session 4: Line Extension of Immediate Release Products (Andrzej Dzierbicki) (PDF/206.79 KB)
First published: 04/05/2015
Last updated: 04/05/2015 -
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Presentation - EMA/EGA workshop - Session 4: Line extension of immediate release products (Alfredo Garcia Arieta) (PDF/505.52 KB)
First published: 04/05/2015
Last updated: 04/05/2015 -
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Presentation - EMA/EGA workshop - Session 5 : Q&A on Other Important Topics (Susana Almeida, Grupo Tecnimede) (PDF/101.46 KB)
First published: 04/05/2015
Last updated: 04/05/2015 -
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Presentation - EMA/EGA workshop - Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (Beata Stepniewska) (PDF/333.94 KB)
First published: 04/05/2015
Last updated: 04/05/2015