2026-07-09 2026-07-09 , online online, 1,290 € zzgl. MwSt. CMC dossier requirements: FDA vs EU

CMC dossier requirements FDA vs EU: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of small and large molecules (chemicals and biologic).

Themen
  • Regulatory landscape in the US
  • Scientific advice
  • The IND and BLA procedure
  • Post-approval/maintenance: Procedures and documentation
  • Requirements for the handling of quality data
  • Hot topics and current challenges


Who should attend
This course meets the needs of all those in the pharmaceutical industry who are involved in marketing authorisation procedures for small and large molecules (chemicals & biologics) and wish to develop their knowledge of the US regulatory environment.
The specific focus is on requirements for quality data.

Both beginners and professionals that are involved in the compilation and maintenance of the CMC documentation for small and large molecules will benefit from this course.
Ziel der Veranstaltung
The purpose of this course is to provide an overview on CMC requirements for marketing authorisation (MA) of small and large molecules (chemicals & biologics) in the US.

The course aims to:
  • familiarise participants with the regulatory landscape;
  • explain the differences between the US and EU MA procedures;
  • provide guidance on FDA specific requirements for the compilation and maintenance of CMC documents;
  • give practical approaches to typical pitfalls

Take the opportunity to meet our experts Dr Juli, Dr Metzner and Dr Jahr and get first-hand information, suggestions and tips for daily business challenges.
Teilnehmerkreis

After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of small and large molecules (chemicals & biologics). Hands-on tipps and tricks and the interactive case study session will enable you to link the theoretical knowledge with the individual challenges of putting it into practice.

Online training Pharma - CMC dossier requirements: FDA vs EU

CMC dossier requirements:
FDA vs EU

Overview on regulatory procedures for chemicals & biologicals (US)

Benefits
  • Considerations for small and large molecules
  • Regulatory update and current developments
  • First-hand information
  • Including case studies & examples
  • Officially certified: ISO 9001 + 21001

Webcode 26102450

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Termin

06/10/2026

06/10/2026

Zeitraum

09:00 am - 5:00 pm CET - Online training
You may dial in 30 minutes before the lecture starts

09:00 am - 5:00 pm CET - Online training
You may dial in 30 minutes before the lecture starts
Veranstaltungsort

online

online

Downloads
PROSPEKT
PROSPEKT
Gebühr

Event - 1,290€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Event - 1,290€ plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Inhouse-Angebote
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Inhouse-Angebot anfordern

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Your contact

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

CMC dossier requirements FDA vs EU: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of small and large molecules (chemicals and biologic).

Themen

  • Regulatory landscape in the US
  • Scientific advice
  • The IND and BLA procedure
  • Post-approval/maintenance: Procedures and documentation
  • Requirements for the handling of quality data
  • Hot topics and current challenges


Who should attend
This course meets the needs of all those in the pharmaceutical industry who are involved in marketing authorisation procedures for small and large molecules (chemicals & biologics) and wish to develop their knowledge of the US regulatory environment.
The specific focus is on requirements for quality data.

Both beginners and professionals that are involved in the compilation and maintenance of the CMC documentation for small and large molecules will benefit from this course.

Ziel der Veranstaltung

The purpose of this course is to provide an overview on CMC requirements for marketing authorisation (MA) of small and large molecules (chemicals & biologics) in the US.

The course aims to:

  • familiarise participants with the regulatory landscape;
  • explain the differences between the US and EU MA procedures;
  • provide guidance on FDA specific requirements for the compilation and maintenance of CMC documents;
  • give practical approaches to typical pitfalls

Take the opportunity to meet our experts Dr Juli, Dr Metzner and Dr Jahr and get first-hand information, suggestions and tips for daily business challenges.

Teilnehmerkreis

After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of small and large molecules (chemicals & biologics). Hands-on tipps and tricks and the interactive case study session will enable you to link the theoretical knowledge with the individual challenges of putting it into practice.