Home

ricompensa in vacanza Punto eudralex vol 10 clinical trials distanza Approvazione abbondanza

PPT - REVISION OF EUDRALEX VOL. 4 - GMP Luisa Stoppa, Ph.D. Inspection and  Certification Department PowerPoint Presentation - ID:6720277
PPT - REVISION OF EUDRALEX VOL. 4 - GMP Luisa Stoppa, Ph.D. Inspection and Certification Department PowerPoint Presentation - ID:6720277

Update on the Clinical Trials Regulation (EU) No 536/2014 - Key developments
Update on the Clinical Trials Regulation (EU) No 536/2014 - Key developments

AIFA notice (update of the AIFA notice published on 12 March 2020) Clinical  trials' management in Italy during the COVID-19 (
AIFA notice (update of the AIFA notice published on 12 March 2020) Clinical trials' management in Italy during the COVID-19 (

GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19  (CORONAVIRUS) PANDEMIC Version 5 10/02/2022
GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC Version 5 10/02/2022

Clinical Trials Regulation (CTR) for medicinal products in application on  31 January 2022
Clinical Trials Regulation (CTR) for medicinal products in application on 31 January 2022

DIRECTIVE” 2001/20/EC
DIRECTIVE” 2001/20/EC

The Tao of Excellence on Twitter: "... good manufacturing practices (#GMPs)  in the #clinicaltrial application, describes the content of the protocol  synopsis,...3/5 #regulatoryaffairs #clinicalinvestigations #MDR #EU #Europe  #clinicaltrials ...
The Tao of Excellence on Twitter: "... good manufacturing practices (#GMPs) in the #clinicaltrial application, describes the content of the protocol synopsis,...3/5 #regulatoryaffairs #clinicalinvestigations #MDR #EU #Europe #clinicaltrials ...

Commission Guideline — Guidance on posting and publication of  result-related information on clinical trials in relation to the
Commission Guideline — Guidance on posting and publication of result-related information on clinical trials in relation to the

GUIDANCE DOCUMENTS CONTAINING THE COMMON PROVISIONS ON THE CONDUCT OF GCP  INSPECTIONS BY COMPETENT AUTHORITIES OF THE DIFFERENT
GUIDANCE DOCUMENTS CONTAINING THE COMMON PROVISIONS ON THE CONDUCT OF GCP INSPECTIONS BY COMPETENT AUTHORITIES OF THE DIFFERENT

Clinical Trials Toolkit Trial Supplies - PDF Free Download
Clinical Trials Toolkit Trial Supplies - PDF Free Download

Process Validation for IMPs: A Matter of Interpretation, or Mandatory?
Process Validation for IMPs: A Matter of Interpretation, or Mandatory?

Updated Draft Q&As for Clinical Trials Regulation 536/2014 released in EudraLex  Volume 10
Updated Draft Q&As for Clinical Trials Regulation 536/2014 released in EudraLex Volume 10

European Regulatory Framework and General Path to Market for ATMPs
European Regulatory Framework and General Path to Market for ATMPs

Frontiers | Transitioning From Preclinical Evidence to Advanced Therapy  Medicinal Product: A Spanish Experience
Frontiers | Transitioning From Preclinical Evidence to Advanced Therapy Medicinal Product: A Spanish Experience

The Parallel Universes of Eudralex Vol 10 – JoBurmester.com
The Parallel Universes of Eudralex Vol 10 – JoBurmester.com

Guidance and Q&As - EMA
Guidance and Q&As - EMA

The CTR: what, when, why and how?
The CTR: what, when, why and how?

New Cro Audit Form | PDF | Clinical Trial | Audit
New Cro Audit Form | PDF | Clinical Trial | Audit

PDF) Clinical trial disclosure and transparency: Regulation EU No. 536/2014  Public disclosure at the clinical trial level
PDF) Clinical trial disclosure and transparency: Regulation EU No. 536/2014 Public disclosure at the clinical trial level

New documents in EudraLex Volume 10 Clinical trials guidelines including an  updated CTA form
New documents in EudraLex Volume 10 Clinical trials guidelines including an updated CTA form

Frontiers | Advanced Therapy Medicinal Products' Translation in Europe: A  Developers' Perspective
Frontiers | Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective

GMP for IMPs in View of the Revision of the EU Clinical Trial Provisions
GMP for IMPs in View of the Revision of the EU Clinical Trial Provisions

Pharmaceuticals | Free Full-Text | Quality Assessment of Investigational  Medicinal Products in COVID-19 Clinical Trials: One Year of Activity at the Clinical  Trials Office | HTML
Pharmaceuticals | Free Full-Text | Quality Assessment of Investigational Medicinal Products in COVID-19 Clinical Trials: One Year of Activity at the Clinical Trials Office | HTML

Clinical trials were missing from regulatory documents of extended-release  methylphenidate for ADHD in adults: a case study of public documents -  Journal of Clinical Epidemiology
Clinical trials were missing from regulatory documents of extended-release methylphenidate for ADHD in adults: a case study of public documents - Journal of Clinical Epidemiology

REVISION OF EUDRALEX VOL. 4 - GMP - ppt download
REVISION OF EUDRALEX VOL. 4 - GMP - ppt download

PDF) Quality Assessment of Investigational Medicinal Products in COVID-19 Clinical  Trials: One Year of Activity at the Clinical Trials Office
PDF) Quality Assessment of Investigational Medicinal Products in COVID-19 Clinical Trials: One Year of Activity at the Clinical Trials Office

EudraLex - Volume 10 - Clinical trials guidelines UPDATED
EudraLex - Volume 10 - Clinical trials guidelines UPDATED

Transforming research ideas into medicinal products for patients. - ppt  download
Transforming research ideas into medicinal products for patients. - ppt download