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Presentation - Population pharmacokinetics/pharmacodynamics in paediatrics: A perspective on the way forward (PDF/848 KB)

Presentation - Population pharmacokinetics/pharmacodynamics in paediatrics: A perspective … Presentation - Population pharmacokinetics/pharmacodynamics in paediatrics: A perspective … Few subjects. • Sparse pharmacokinetic sampling. • Sparse pharmacodynamic sampling. • Acceptability …

First published: 14/04/2008
Last updated: 14/04/2008
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Presentation - Statistical modelling issues arising from pharmacokinetic/pharmacodynamic bridging in paediatrics (PDF/290.45 KB)

modelling issues arising from pharmacokinetic/pharmacodynamic bridging in paediatrics … modelling issues arising from pharmacokinetic/pharmacodynamic bridging in paediatrics 14/04/2008 …

First published: 14/04/2008
Last updated: 14/04/2008
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ICH: E 15: Establish definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories - Step 5 (PDF/47.48 KB)

definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding … definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding … biomarkers, phamacogenomics, pharmacogenetics, genomic data and sample coding …

Adopted
First published: 01/11/2007
Last updated: 01/11/2007
Legal effective date: 01/05/2008
EMEA/CHMP/ICH/437986/2006
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ICH: E 15: Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories - Step 4 (PDF/48.99 KB)

Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding … Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding … Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding …

Adopted
First published: 01/11/2007
Last updated: 01/11/2007
Legal effective date: 01/05/2008
EMEA/CHMP/ICH/437986/2006
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Presentation - Pharmacokinetic-Pharmacodynamic (PKPD) modelling to inform efficacyin paediatric antimicrobial trials (J.Standing, UCL) (PDF/1.65 MB)

Presentation - Pharmacokinetic-Pharmacodynamic (PKPD) modelling to inform … ument details Presentation - Pharmacokinetic-Pharmacodynamic (PKPD) modelling to inform …

First published: 29/10/2018
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Pharmacovigilance: Regulatory and procedural guidance

Last updated: 29/04/2016

Pharmacovigilance: Regulatory and procedural … Pharmacovigilance: Regulatory and procedural … variations to an existing pharmacovigilance system as described in the …
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Pharmacovigilance: post-authorisation

Last updated: 28/03/2017

Pharmacovigilance: post-authorisation … Pharmacovigilance: post-authorisation …
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Pharmacovigilance: research and development

Last updated: 28/03/2017

Pharmacovigilance: research and development … the sections below: Good pharmacovigilance practices : see Modules I Pharmacovigilance systems) and II Pharmacovigilance system master file) Patient …
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Pharmacovigilance: marketing authorisation

Last updated: 28/03/2017

Pharmacovigilance: marketing authorisation … information can be found under 'Pharmacovigilance - Overview' pharmacovigilance activities designed to further … information can be found under 'Pharmacovigilance - Overview' …
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Clinical pharmacology and pharmacokinetics

Last updated: 26/03/2010

Clinical pharmacology and pharmacokinetics … Clinical pharmacology and pharmacokinetics …
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Clopidogrel Acino Pharma-H-C-1172-A20-04: EPAR - Assessment Report - Variation (PDF/552.56 KB)

Clopidogrel Acino Pharma-H-C-1172-A20-04: EPAR - Assessment Report … details Clopidogrel Acino Pharma-H-C-1172-A20-04: EPAR - Assessment Report … report for Clopidogrel Acino Pharma International Non-proprietary …

Adopted
First published: 30/03/2011
Last updated: 26/07/2012
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Clopidogrel 1A Pharma-H-1054-A-20-0004: EPAR - Assessment Report (PDF/304.73 KB)

Clopidogrel 1A Pharma-H-1054-A-20-0004: EPAR - Assessment Report … ument details Clopidogrel 1A Pharma-H-1054-A-20-0004: EPAR - Assessment Report … Clopidogrel 1A Pharma H-1054-A-20- 04 Assessment …

Adopted
First published: 28/02/2011
Last updated: 28/02/2011
EMA/11498/2011
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Presentation - Veterinary pharmacovigilance: Outline of the EU pharmacovigilance system (PDF/857.51 KB)

Presentation - Veterinary pharmacovigilance: Outline of the EU pharmacovigilance system … Presentation - Veterinary pharmacovigilance: Outline of the EU pharmacovigilance system 17/12/2010 17/12/2010 … Pharmacovigilance Pharmacovigilance Veterinary pharmacovigilance Outline of the EU pharmacovigilance system Presented by: Peter …

First published: 17/12/2010
Last updated: 17/12/2010
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Standard operating procedure for management of general external pharmacovigilance-related queries assigned to the pharmacovigilance dashboard in JIRA (PDF/135 KB)

management of general external pharmacovigilance-related queries assigned to the pharmacovigilance dashboard in JIRA … management of general external pharmacovigilance-related queries assigned to the pharmacovigilance dashboard in JIRA SOP/H/3293Adopted …

Adopted
First published: 23/06/2009
Last updated: 15/01/2016
Legal effective date: 12/01/2016
SOP/H/3293
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Presentation - Pharmacokinetic-pharmacodynamic modelling to support go / no-go decisions for a novel gp120 inhibitor - Break-out session 1 theme 3 (PDF/318.01 KB)

Presentation - Pharmacokinetic-pharmacodynamic modelling to support go … ument details Presentation - Pharmacokinetic-pharmacodynamic modelling to support go … Pharmacometrics Global Clinical Pharmacology PK-PD modelling to support …

First published: 30/11/2011
Last updated: 30/04/2012
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Presentation - Assumption setting in a semi-mechanistic population pharmacokinetic-pharmacodynamic model across a wide range of patients - Break-out session 3 theme 1 (PDF/763.97 KB)

semi-mechanistic population pharmacokinetic-pharmacodynamic model across a wide range … semi-mechanistic population pharmacokinetic-pharmacodynamic model across a wide range … population be used? Is the pharmacological action similar? Can in …

First published: 30/11/2011
Last updated: 30/04/2012
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Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2022 (PDF/263.61 KB)

Pharmacovigilance-related regulatory recommendations … Document details Pharmacovigilance-related regulatory recommendations … Veterinary Medicines Division Pharmacovigilance-related regulatory recommendations …

First published: 04/02/2022
Last updated: 16/12/2022
EMA/CVMP/PhVWP/48138/2022
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EudraVigilance user declaration for qualified person for pharmacovigilance/responsible person for EudraVigilance (PDF/118.1 KB)

for qualified person for pharmacovigilance/responsible person for EudraVigilance … for qualified person for pharmacovigilance/responsible person for EudraVigilance … for qualified person for pharmacovigilance/responsible person for EudraVigilance …

First published: 17/06/2016
Last updated: 14/12/2022
EMA/204890/2017
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Referral: Pharmasin

tylosin tartrate, associated names: Tylmasin, Article 33
Status: European Commission final decision, opinion/position date: 12/03/2009, EC decision date: 08/01/2010, Last updated: 30/04/2010

Pharmasin … Recommendation provided by Pharmacovigilance Risk Assessment Committee … decentralised procedure for Pharmasin 100% W/W Water Soluble Granules …
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Control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph “Substances for Pharmaceutical Use” and general chapter “Control of Impurities in Substances for Pharmaceutical Use” - Scientific guideline

Last updated: 17/02/2023

Control of impurities of pharmacopoeial substances: compliance with … compliance with the European Pharmacopoeia general monograph “Substances … monograph “Substances for Pharmaceutical Use” and general chapter …
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Non-clinical: pharmacology and safety pharmacology

Last updated: 25/05/2016

Non-clinical: pharmacology and safety pharmacology … guidelines on non-clinical pharmacology help medicine developers …
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Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2021 (PDF/177.02 KB)

Pharmacovigilance-related regulatory recommendations … Document details Pharmacovigilance-related regulatory recommendations … Veterinary Medicines Division Pharmacovigilance-related regulatory recommendations …

First published: 22/02/2021
Last updated: 17/12/2021
EMA/CVMP/PhVWP/105691/2021
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European Network of Centres for Pharmacoepidemiology and Pharmacovigilance scientific convention - European Union (EU) healthcare databases for pan-EU pharmacoepidemiological research

London, UK, 25/11/2008, Last updated: 25/11/2008

opean Network of Centres for Pharmacoepidemiology and Pharmacovigilance scientific convention - European … healthcare databases for pan-EU pharmacoepidemiological research … opean Network of Centres for Pharmacoepidemiology and Pharmacovigilance scientific convention - European …
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Development pharmaceutics for biotechnological and biological products (Annex to note for guidance on development pharmaceutics) - Scientific guideline

Last updated: 21/10/1999

Development pharmaceutics for biotechnological and … for guidance on development pharmaceutics) - Scientific guideline … Development pharmaceutics for biotechnological and …
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Presentation - Pharmacometrics: a solid scientific basis for pharmacostatistical dose finding (Mick Looby) (PDF/264.63 KB)

Presentation - Pharmacometrics: a solid scientific basis for pharmacostatistical dose finding (Mick Looby … ument details Presentation - Pharmacometrics: a solid scientific basis for pharmacostatistical dose finding (Mick Looby … Agency/European Federation of Pharmaceutical Industries and Associations …

First published: 07/01/2015
Last updated: 07/01/2015

50972 results

Presentation - Population pharmacokinetics/pharmacodynamics in paediatrics: A perspective on the way forward (PDF/848 KB)

Presentation - Statistical modelling issues arising from pharmacokinetic/pharmacodynamic bridging in paediatrics (PDF/290.45 KB)

ICH: E 15: Establish definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories - Step 5 (PDF/47.48 KB)

ICH: E 15: Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories - Step 4 (PDF/48.99 KB)

Presentation - Pharmacokinetic-Pharmacodynamic (PKPD) modelling to inform efficacyin paediatric antimicrobial trials (J.Standing, UCL) (PDF/1.65 MB)

Pharmacovigilance: Regulatory and procedural guidance

Pharmacovigilance: post-authorisation

Pharmacovigilance: research and development

Pharmacovigilance: marketing authorisation

Clinical pharmacology and pharmacokinetics

Clopidogrel Acino Pharma-H-C-1172-A20-04: EPAR - Assessment Report - Variation (PDF/552.56 KB)

Clopidogrel 1A Pharma-H-1054-A-20-0004: EPAR - Assessment Report (PDF/304.73 KB)

Presentation - Veterinary pharmacovigilance: Outline of the EU pharmacovigilance system (PDF/857.51 KB)

Standard operating procedure for management of general external pharmacovigilance-related queries assigned to the pharmacovigilance dashboard in JIRA (PDF/135 KB)

Presentation - Pharmacokinetic-pharmacodynamic modelling to support go / no-go decisions for a novel gp120 inhibitor - Break-out session 1 theme 3 (PDF/318.01 KB)

Presentation - Assumption setting in a semi-mechanistic population pharmacokinetic-pharmacodynamic model across a wide range of patients - Break-out session 3 theme 1 (PDF/763.97 KB)

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2022 (PDF/263.61 KB)

EudraVigilance user declaration for qualified person for pharmacovigilance/responsible person for EudraVigilance (PDF/118.1 KB)

Referral: Pharmasin

Control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph “Substances for Pharmaceutical Use” and general chapter “Control of Impurities in Substances for Pharmaceutical Use” - Scientific guideline

Non-clinical: pharmacology and safety pharmacology

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2021 (PDF/177.02 KB)

European Network of Centres for Pharmacoepidemiology and Pharmacovigilance scientific convention - European Union (EU) healthcare databases for pan-EU pharmacoepidemiological research

Development pharmaceutics for biotechnological and biological products (Annex to note for guidance on development pharmaceutics) - Scientific guideline

Presentation - Pharmacometrics: a solid scientific basis for pharmacostatistical dose finding (Mick Looby) (PDF/264.63 KB)