Forum Institut für Management GmbH

PharmaFORUM Webcast Biologics "CMC requirements ATMPs: interface Production + RA" - 9 July 2020

Forum Institut für Management GmbH
Online

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Wichtige informationen

Tipologie Kurs
Methodologie Online
Dauer 365 Tage
Beginn nach Wahl
  • Kurs
  • Online
  • Dauer:
    365 Tage
  • Beginn:
    nach Wahl
Beschreibung

Do you work with biologics? Then, we would like to invite you to join our live webcast series.


Industry and authority experts will provide you with the latest information on the current challenges in analytics, development, quality and regulatory affairs (pre- and post-authorisation phases) of biologics every monthly. Most webcasts are specifically focused on CMC while addressing topics at the interface Quality and Regulatory Affairs.


You will meet our experts in a virtual conference room and share your experiences live. Each meeting will be held as a 1.5 to 2-hour webcast, presenting the latest news with supporting presentation slides. To be best prepared, you will be able to download the complete presentation documents prior to each webcast.


Are you unable to attend one of the webcasts? No problem! Following each live meeting, you will be able to retrieve the recorded webcast (audio track and presentation) from our eLearning Centre, using your personal password. This allows you to review each presentation at any time and as often as you like.

Einrichtungen (1)
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Zu berücksichtigen

· An wen richtet sich dieser Kurs?

This webcast series addresses the needs of managers in the biopharmaceutical industry needing to keep up to date with development, quality, analytics and regulatory affairs, in particular with CMC related topics.

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Was lernen Sie in diesem Kurs?

Interface

Themenkreis

- Brief summary of legal and regulatory requirements and procedures for ATMPs in the EU and USA - CMC for ATMPs: different product types and requirements from early development to marketing - Common pitfalls and specific examples of key regulatory issues for CMC of ATMPs - Issues and potential strategies for integrating regulatory affairs into CMC development for ATMPs and product lifecycle