Forum Institut für Management GmbH

eCTD Life Cycle Management - National and Global - Integration of national requirements in global life cycle management

Forum Institut für Management GmbH
In München

1.090 
zzgl. MwSt.
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Wichtige informationen

Tipologie Seminar
Ort München
Dauer 1 Tag
Beginn 27.02.2020
  • Seminar
  • München
  • Dauer:
    1 Tag
  • Beginn:
    27.02.2020
Beschreibung

This seminar will address peculiarities both in developing and submitting an eCTD within the ICH region and in global eSubmission requirements. It will make you aware of the duties involved in applying for a marketing authorisation in the ICH region and in LATAM, ASEAN, the Middle East and Africa.


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It will also make you especially knowledgeable of your life cycle management duties and provide best-practice tips on how to integrate national requirements in your global life cycle management.


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Ultimately, it will show you how to optimise your regulatory operations and IT support.

Einrichtungen (1)
Wo und wann
Beginn Lage
27.Feb. 2020
München
Berliner Str. 93, 80805, Bayern, Deutschland
Karte ansehen
Beginn 27.Feb. 2020
Lage
München
Berliner Str. 93, 80805, Bayern, Deutschland
Karte ansehen

Zu berücksichtigen

· An wen richtet sich dieser Kurs?

This seminar addresses the needs of regulatory and medical affairs personnel in the pharmaceutical industry who intend to submit and manage marketing authorisation dossiers within and beyond the ICH region.

- Prior knowledge of the ICH eCTD is required.

Fragen & Antworten

Teilen Sie Ihre Fragen und andere User können Ihnen antworten

Was lernen Sie in diesem Kurs?

IT
Management

Themenkreis

- eCTD requirements in Europe, the US and the ICH region - Electronic submission requirements in LATAM, ASEAN, the Middle East and Africa - Life cycle management: dealing with line extensions, new manufacturers, etc. - Challenges of parallel submissions and splitting procedures - Master data concept and core dossier