2021-12-08 2022-02-09 , Online Online, 1.090,- € zzgl. MwSt. Dr. Ulrich Granzer https://www.forum-institut.de/seminar/2202271-regulatory-affairs-in-the-us/referenten/22/22_02/2202271-online-training-course-pharma-regulatory-affairs-in-the-us_granzer-ulrich.jpg Regulatory Affairs in the US

Meet the expert Dr. Ulrich Granzer and get first-hand information, hints and tips for your daily business challenges with FDA approval of a medicine for the US market!

Topics
  • Drug regulation in the USA
  • The IND, NDA, BLA procedures
  • Communication with the FDA
  • Marketing authorisation granted: The arising duties
  • Workshop to directly apply the theory
Aims and objectives
The purpose of this course is to provide an overview of the regulatory environment in the US.

After your participation you will
- be familiar with the requirements for FDA approval of a medicine for the US market
- have gained insight into the different development pathways
- know how to interact with the FDA
- understand the differences between the US vs. the EU approval process

Meet the expert Dr. Ulrich Granzer and get first-hand information, hints and tips for your daily business challenges!
Who should attend

This training course meets the needs of all those from the pharmaceutical industry who wish to develop their knowledge of the US regulatory environment including allied industries who wish to have a comprehensive understanding of the subject.

Online training course - Regulatory Affairs in the US

Regulatory Affairs in the US

- Online training -

Benefits
  • Meet the experts!
  • First-hand information
  • Experts with local know-how
  • Provide your individual questions beforehand
  • We are following the IMI quality criteria

Webcode 2202271

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Termin

08. - 09.02.2022

08. - 09.02.2022

Zeitraum

both days from 1:00 pm - 5:00 pm

both days from 1:00 pm - 5:00 pm
Veranstaltungsort

Online

Online

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Gebühr
Ihr Ansprechpartner

Dr. Birgit Wessels
Conference Manager

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

Details

Meet the expert Dr. Ulrich Granzer and get first-hand information, hints and tips for your daily business challenges with FDA approval of a medicine for the US market!

Topics
  • Drug regulation in the USA
  • The IND, NDA, BLA procedures
  • Communication with the FDA
  • Marketing authorisation granted: The arising duties
  • Workshop to directly apply the theory
Aims and objectives

The purpose of this course is to provide an overview of the regulatory environment in the US.

After your participation you will
- be familiar with the requirements for FDA approval of a medicine for the US market
- have gained insight into the different development pathways
- know how to interact with the FDA
- understand the differences between the US vs. the EU approval process

Meet the expert Dr. Ulrich Granzer and get first-hand information, hints and tips for your daily business challenges!

Who should attend

This training course meets the needs of all those from the pharmaceutical industry who wish to develop their knowledge of the US regulatory environment including allied industries who wish to have a comprehensive understanding of the subject.

Detailed programme

both days from 1:00 pm - 5:00 pm

13:00 Opening and introduction round


13:15

Drug regulation in the USA
  • Role, duties and responsibilities oft he FDA: CBER, CDER, ...
  • FDARA, PDUFA VI, UFAs
  • Current developments

13:45

The IND (Investigational New Drug) procedure
  • Clinical trials in the US, mandatory?
  • Main aspects and differences for the compilation of IND and IMPD
  • Practical experiences
  • Avoiding typical mistakes

15:00 Coffee break


15:15

The NDA (New Drug Application) and BLA (Biological License Application) procedure
  • Dossier requirements
  • ANDA procedure
  • Drug master files
  • When NDA, when BLA?
  • Practical experiences
  • Avoiding typical mistakes

16:45 Summary and outstanding questions


17:00 End of training day I


13:00

Communication with the FDA
  • Meeting types: Pre-IND meeting, End of phase II, Pre-submission, Advisory committee meetings, ...
  • Planning and holding FDA meetings
  • Starting the communication: Meeting agenda

14:15 Coffee break


14:30

Workshop
You work in small groups on one task, e.g. Briefing Book prepartion, deficency letter analysis, etc.; discussion of results with the plenum.

15:30

Marketing authorisation granted: The arising duties
  • Maintenance of INDs, NAD, BLA
  • Reporting obligations
  • Annual report
  • Dossier changes
  • Practical experiences
  • Avoiding typical mistakes

16:45 Summary and outstanding questions


17:00 End of training course


More information

Send us your individual questions

Please send us your questions concerning the seminar topics in advance.

We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.

Please send your questions to b.wessels@forum-institut.de

How does an online seminar work?

Our online training courses are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live.

1. You will receive brief instructions on how to use Zoom beforehand.
2. 48 hours before the online seminar, you will receive an email with an access link and a meeting ID.
3. Use a headset, loudspeakers or the telephone for audio.
4. Listen to the speaker and follow the presentation.
5. Feel free to switch from silent to audio mode by yourself any time to ask your questions.

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