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

EventCorporateRegulatory and procedural guidanceMedicines

Date: Thursday, 30 April 2015, All day
Location: European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

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 ...

Reference Number: EMA/157739/2015

English (EN) (162.47 KB - PDF)

First published: 16/03/2015 Last updated: 30/04/2015

Presentation - EMA/EGA workshop - Session 1: Orally Administered Modified Release Products (Gerald Beuerle)

English (EN) (198.71 KB - PDF)

First published: 04/05/2015 Last updated: 04/05/2015

Presentation - EMA/EGA workshop - Session 1: Orally administered Modified Release Products - European Regulatory Requirements (Henrike Potthast)

English (EN) (1.2 MB - PDF)

First published: 04/05/2015 Last updated: 04/05/2015

Presentation - EMA/EGA workshop - Session 2 :Injectable Modified Release Products (Yu Chung Tsang)

English (EN) (105.48 KB - PDF)

First published: 04/05/2015 Last updated: 04/05/2015

Presentation - EMA/EGA workshop - Session 2: Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms - Injectable modified release products (Sotiris Michaleas)

English (EN) (454.54 KB - PDF)

First published: 04/05/2015 Last updated: 04/05/2015

Presentation - EMA/EGA workshop - Session 3: Transdermal Products (PK + Adhesion + Irritation/Sensitization) (Bjà¶rn Schurad)

English (EN) (172.46 KB - PDF)

First published: 04/05/2015 Last updated: 04/05/2015

Presentation - EMA/EGA workshop - Session 3: TDDS and Appendix I + II (Jan Neuhauser)

English (EN) (807.08 KB - PDF)

First published: 04/05/2015 Last updated: 04/05/2015

Presentation - EMA/EGA workshop - Session 4: Line Extension of Immediate Release Products (Andrzej Dzierbicki)

English (EN) (206.79 KB - PDF)

First published: 04/05/2015 Last updated: 04/05/2015

Presentation - EMA/EGA workshop - Session 4: Line extension of immediate release products (Alfredo Garcia Arieta)

English (EN) (505.52 KB - PDF)

First published: 04/05/2015 Last updated: 04/05/2015

Presentation - EMA/EGA workshop - Session 5 : Q&A on Other Important Topics (Susana Almeida, Grupo Tecnimede)

English (EN) (101.46 KB - PDF)

First published: 04/05/2015 Last updated: 04/05/2015

Presentation - EMA/EGA workshop - Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (Beata Stepniewska)

English (EN) (333.94 KB - PDF)

First published: 04/05/2015 Last updated: 04/05/2015

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