PDA EU00018 CMC Regulatory Compliance for Biopharmaceuticals - Training / Workshop von PDA Europe gGmbH

Inhalte

Biopharmaceuticals (recombinant proteins, monoclonal antibodies, fusion proteins, bispecific antibodies, antibody-drug conjugates, and biosimilars) are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the regulatory requirements for these challenging products. Frequently the development of the CMC strategy is an afterthought.

This course will provide insights and practical guidance for the CMC teams to develop an appropriate cost-effective, risk-based CMC regulatory compliance strategy for the manufacture and control of biopharmaceuticals from early clinical stage development through market approval. The course emphasis will include FDA, EMA and ICH guidance.

Biopharmaceuticals (recombinant proteins, monoclonal antibodies, fusion proteins, bispecific antibodies, antibody-drug conjugates, and biosimilars) are being developed by many companies whose Chemistry ...

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Lernziele

Upon completion of this course, attendees will be able to:

  • Understand the importance and underlying principles of an effective CMC regulatory strategy for biopharmaceuticals to move their products through clinical development into the marketplace
  • Learn how to avoid major CMC delays in clinical development or market approval due to an ineffective CMC regulatory compliance strategy

Upon completion of this course, attendees will be able to:

  • Understand the importance and underlying principles of an effective CMC regulatory strategy for biopharmaceuticals to move their products th ...
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Zielgruppen

This CMC regulatory compliance course is designed for senior management, directors, managers, supervisors, project planners and professional staff seeking to develop or implement a Chemistry, Manufacturing & Controls (CMC) regulatory compliant strategy for biopharmaceuticals. Typical attendees are from the disciplines of Process Development, Analytical Development, Manufacturing, Quality Control, Quality Assurance and Regulatory Affairs.

This CMC regulatory compliance course is designed for senior management, directors, managers, supervisors, project planners and professional staff seeking to develop or implement a Chemistry, Manufact ...

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Termine und Orte

Datum Uhrzeit Dauer Preis
Amsterdam, NL
22.09.2022 - 23.09.2022 09:00 - 17:30 Uhr 16 h Mehr Informationen > Jetzt buchen ›

SG-Seminar-Nr.: 6183184

Termine

  • 22.09.2022 - 23.09.2022

    Amsterdam, NL

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Veranstaltungsinformation

  • Training / Workshop
  • Englisch
    • Teilnahmebestätigung
  • 16 h
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  • Anbieterbewertung (40)

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Datum Uhrzeit Dauer Preis
Amsterdam, NL
22.09.2022 - 23.09.2022 09:00 - 17:30 Uhr 16 h Mehr Informationen > Jetzt buchen ›