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The Art of doing Clinical Regulatory well - Real Regulatory
The Art of doing Clinical Regulatory well - Real Regulatory

THE IMPACT OF AMENDMENTS IN CLINICAL TRIALS ON DRUGS - ppt download
THE IMPACT OF AMENDMENTS IN CLINICAL TRIALS ON DRUGS - ppt download

Clinical trials in the EU - Laura Pioppo
Clinical trials in the EU - Laura Pioppo

The Clinical Trials Directive: How Is It Affecting Europe's Noncommercial  Research | PLOS ONE
The Clinical Trials Directive: How Is It Affecting Europe's Noncommercial Research | PLOS ONE

THE IMPACT OF AMENDMENTS IN CLINICAL TRIALS ON DRUGS - ppt download
THE IMPACT OF AMENDMENTS IN CLINICAL TRIALS ON DRUGS - ppt download

Addendum to the Guidance on the Management of Clinical Trials during the  COVID-19 (Coronavirus) pandemic Date: 25.3.2020 Versio
Addendum to the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic Date: 25.3.2020 Versio

NOTIFICATION OF A SUBSTANTIAL AMENDMENT TO A CLINICAL TRIAL ON A MEDICINAL  PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AN
NOTIFICATION OF A SUBSTANTIAL AMENDMENT TO A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AN

How to Address—and Overcome—Operational Challenges in Master Protocol  Studies
How to Address—and Overcome—Operational Challenges in Master Protocol Studies

THE IMPACT OF AMENDMENTS IN CLINICAL TRIALS ON DRUGS - ppt download
THE IMPACT OF AMENDMENTS IN CLINICAL TRIALS ON DRUGS - ppt download

Submitting a CTA application
Submitting a CTA application

49 Annex 2: Substantial Amendment Form NOTIFICATION OF A SUBSTANTIAL  AMENDMENT TO A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR
49 Annex 2: Substantial Amendment Form NOTIFICATION OF A SUBSTANTIAL AMENDMENT TO A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR

EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL. Brussels, ENTR/F2/BL  D(2003) CT 1 Revision 2 - PDF Free Download
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL. Brussels, ENTR/F2/BL D(2003) CT 1 Revision 2 - PDF Free Download

1. Name of service Approval for the substantial amendment (to a clinical  trial on a medicinal product for human use) 2. Recipien
1. Name of service Approval for the substantial amendment (to a clinical trial on a medicinal product for human use) 2. Recipien

Rethinking trials: the pros and cons of protocol amendments - PMLiVE
Rethinking trials: the pros and cons of protocol amendments - PMLiVE

Time lines for CTA - Paul-Ehrlich-Institut
Time lines for CTA - Paul-Ehrlich-Institut

Amendment to an authorised clinical trial– step by step
Amendment to an authorised clinical trial– step by step

EU's Clinical Trials Regulation and portal goes live 31 January
EU's Clinical Trials Regulation and portal goes live 31 January

Amendments to clinical trial application (CTA)
Amendments to clinical trial application (CTA)

THE IMPACT OF AMENDMENTS IN CLINICAL TRIALS ON DRUGS - ppt download
THE IMPACT OF AMENDMENTS IN CLINICAL TRIALS ON DRUGS - ppt download

Guide to Clinical Trials Regulation-National Collaboration Project  (CTR-NCP) Health Products Regulatory Authority and National
Guide to Clinical Trials Regulation-National Collaboration Project (CTR-NCP) Health Products Regulatory Authority and National

Substantial Amendments
Substantial Amendments

AMENDMENTS
AMENDMENTS

substantial_amendment_notification_form
substantial_amendment_notification_form

Guidance for the Submission and Conduct of Clinical Trials (CT) with  Medicinal Products - PDF Free Download
Guidance for the Submission and Conduct of Clinical Trials (CT) with Medicinal Products - PDF Free Download

Assessment of substantial amendments at the MPA
Assessment of substantial amendments at the MPA

Detailed guidance for the request for authorisation of a clinical trial on  a medicinal product for human use to the competent au
Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent au

During your study:
During your study:

NOTICE OF SUBSTANTIAL AMENDMENT
NOTICE OF SUBSTANTIAL AMENDMENT