2024-04-16 2024-04-16 , online online, 1,190 € zzgl. MwSt. Dr. Christina Juli https://www.forum-institut.de/seminar/24102450-cmc-dossier-requirements-for-biologics-fda-vs-eu/referenten/24/24_10/24102450-online-training-pharma-cmc-requirements-for-biologics-in-the-us_juli-christina.jpg CMC dossier requirements for biologics: FDA vs EU

CMC requirements in the US: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of large molecules/biologics.

Topics
  • Regulatory landscape in the US
  • Scientific advice
  • The IND and BLA procedure
  • Post-approval/maintenance: Procedures and documentation
  • Quality data for marketing authorisation
  • Case studies


Who should attend
This course meets the needs of all those in the pharmaceutical industry who are involved in marketing authorisation procedures for large molecules/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 large molecules will benefit from this course.
Aims and objectives
The purpose of this course is to provide an overview on CMC requirements for marketing authorisation (MA) of large molecules/ 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 and Dr Metzner and get first-hand information, suggestions and tips for daily business challenges.
Your benefit

After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of large molecules/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 requirements for biologics in the US

CMC dossier requirements for biologics: FDA vs EU

- Online training -

Benefits
  • First-hand information
  • Including case studies and many practical examples
  • Submit your questions prior to the course
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 24102450

Jetzt buchen

JETZT Buchen
Referenten

Dr. Christina Juli

Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany

Head of CMC Management CMB Dr Christina Juli studied pharmacy at the University of Würzburg, Germany. After her PhD thesis in the fields of pharmaceutical chemistry, in 2012, she joined the ratiopharm GmbH in Ulm, Germany. She started her professional career as Senior Manager in the department of EU Regulatory Affairs Generic Maintenance. Since 2018, she is working at the manufacturing site for biopharmaceuticals of Boehringer Ingelheim Pharma GmbH & Co. KG in Biberach, Germany. In her role as Head of CMC Management CMB, she focuses on the CMC development for biologics and is responsible for the definition compilation and review of the CMC documentation for clinical trial and new drug applications as well as for post approval submissions worldwide. Beyond that, as regulatory intelligence responsible for her business unit, she monitors the regulatory legislation, regulations, guidelines and position papers from pharmaceutical and biological industry worldwide. She is an active participant in the BioPhorum Operations Group.

Dr. Beatrix Metzner

Boehringer Ingelheim Biopharmaceuticals GmbH, Biberach an der Riss

Head of CMC Management Biopharma More than 15 years' experience in filing pre and post-approval worldwide, with a specific focus on biologics (NBE and biosimilar)

Alles auf einen Blick

Termin

23/10/2024

23/10/2024

Zeitraum

09:00 am - 5:00 pm - online seminar
You may dial in 30 minutes before the training starts

09:00 am - 5:00 pm - online seminar
You may dial in 30 minutes before the training starts
Veranstaltungsort

online

online

Downloads
Gebühr

Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

Dr. Birgit Wessels
Conference Manager

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

Details

CMC requirements in the US: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of large molecules/biologics.

Topics

  • Regulatory landscape in the US
  • Scientific advice
  • The IND and BLA procedure
  • Post-approval/maintenance: Procedures and documentation
  • Quality data for marketing authorisation
  • Case studies


Who should attend
This course meets the needs of all those in the pharmaceutical industry who are involved in marketing authorisation procedures for large molecules/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 large molecules will benefit from this course.

Aims and objectives

The purpose of this course is to provide an overview on CMC requirements for marketing authorisation (MA) of large molecules/ 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 and Dr Metzner and get first-hand information, suggestions and tips for daily business challenges.

Your benefit

After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of large molecules/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.

Detailed programme

09:00 am - 5:00 pm - online seminar
You may dial in 30 minutes before the training starts

Welcome, introduction, expectations


Regulatory landscape in the US
  • Role, duties and responsibilities of the FDA: CBER, CDER, etc.
  • Legislation
  • Current developments
  • US vs EU - ICH harmonisation?

Coffee break


Scientific advice
  • -Communication with the authority, additional and differing procedures FDA vs EU
  • Avoiding typical mistakes

The IND and BLA procedure
  • Main aspects and differences for the compilation of IND and BLA, additional and differing procedures FDA vs EU
  • Dossier requirements
  • Practical experiences from industry perspective
  • Avoiding typical mistakes

Lunch break


Maintenance/lifecycle management
  • Post-approval changes: Standards in the ICH region, additional and differing procedures FDA vs EU

Quality data for marketing authorization
  • CMC requirements FDA vs EU
  • FDA specific documentation to be included in the global dossier

Coffee break


Case studies
The two experts will present case studies and you as participant will work in groupson tasks refering to it. Final discussion in the plenum.

Summary and outstanding questions


End of the online training course


More information

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All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.

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Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

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