Global CMC Requirements covering the Product Lifecycle - Quality data for non-EU and management of company's global CMC interfaces

Seminar

Online

1.590 € zzgl. MwSt.

Beschreibung

  • Kursart

    Seminar

  • Methodik

    Online

  • Dauer

    2 Tage

  • Beginn

    nach Wahl

The focus of this seminar is on CMC requirements in non-EU countries. Another key topic is the question on how to continuously secure regulatory compliance along the international interfaces.

Our experts will pass on their in-depth knowledge of standards especially for the Brazilian, Chinese, Russian and Japanes markets. They will share their experience on international variation management and give you an insight into the world of GMP. During the workshop you will have the opportunity to discuss and share your compliance issues and find personal solutions.


After attending the seminar, you will have a profound understanding of your CMC duties within the international pharmaceutical environment covering both: concrete content related topics and managerial interactivities at the interfaces: Thereby improving your skills to work towards the expectations of your interfaces.

Standorte und Zeitplan

Lage

Beginn

Online

Beginn

nach WahlAnmeldung möglich

Hinweise zu diesem Kurs


This seminar addresses the needs of those working in the international pharmaceutical industry. It will particularly benefit those dealing with international regulatory CMC topics and interfaces, such as

- CMC managers
- Regulatory Affairs managers
- Regional Affairs managers
- Quality Compliance managers
- Quality Assurance managers

Fragen & Antworten

Ihre Frage hinzufügen

Unsere Berater und andere Nutzer werden Ihnen antworten können

Wer möchten Sie Ihre Frage beantworten?

Geben Sie Ihre Kontaktdaten ein, um eine Antwort zu erhalten

Es werden nur Ihr Name und Ihre Frage veröffentlicht.

Meinungen

Erfolge dieses Bildungszentrums

2020

Sämtlich Kurse sind auf dem neuesten Stand

Die Durchschnittsbewertung liegt über 3,7

Mehr als 50 Meinungen in den letzten 12 Monaten

Dieses Bildungszentrum ist seit 16 Mitglied auf Emagister

Themen

  • Management
  • International
  • Compliance

Inhalte

- Quality data for marketing authorisation and for post-approval changes with focus Brazil, China, Russia and Japan - Assurance of compliance at international level - General management of company's global CMC interfaces including a workshop

Global CMC Requirements covering the Product Lifecycle - Quality data for non-EU and management of company's global CMC interfaces

1.590 € zzgl. MwSt.