2021-12-05 2022-04-06 , Online Online, 1.090,- € zzgl. MwSt. Dr Mohamed Oubihi https://www.forum-institut.de/seminar/22042011-regulatory-affairs-in-japan/referenten/22/22_04/22042011-course-regulatory-affairs-japan_oubihi-mohamed.jpg Regulatory Affairs in Japan

Here you will get useful information for your marketing authorisation and the CMC requirements in Japan. It includs also abridged procedures and cultural considerations

Topics
  • PMDA consultation: strategic and operational considerations
  • ODD, conditional approval and the JNDA process
  • CMC requirements for Japan
  • Clinical trial notification
Aims and objectives
This online course spread over two half days explains what needs to be done when applying for a marketing authorisation in Japan, and the challenges of the application process, from the clinical trial notification to the final marketing authorisation. It will specify what you need to keep in mind when it comes to the specific Japanese CMC requirements and provide useful tips for communication with the authorities.
Who should attend

This unique course addresses the needs of professionals in the healthcare industry involved in registering, exporting and manufacturing pharmaceuticals in Japan.

Members of the following departments in particular will benefit from the speaker's expertise:

  • Business Development
  • Regulatory Affairs
  • Market Access
  • Export

Course Regulatory Affairs Japan

Regulatory Affairs Japan

Benefits
  • Expert with local know-how
  • PMDA, NJDA, ODD in detail
  • CMC and regulatory strategy combined
  • We are following the IMI quality criteria

Webcode 22042011

Jetzt buchen

JETZT Buchen

Referent


Alles auf einen Blick

Termin

05. - 06.04.2022

05. - 06.04.2022

Zeitraum

10:00 - 14:00 each day You may dial ...

10:00 - 14:00 each day You may dial in 30 min. before the session
Veranstaltungsort

Online

Online

Gebühr
Ihr Ansprechpartner

Dr. Henriette Wolf-Klein
Head of Department

+49 6221 500-680
h.wolf-klein@forum-institut.de

Details

Here you will get useful information for your marketing authorisation and the CMC requirements in Japan. It includs also abridged procedures and cultural considerations

Topics
  • PMDA consultation: strategic and operational considerations
  • ODD, conditional approval and the JNDA process
  • CMC requirements for Japan
  • Clinical trial notification
Aims and objectives

This online course spread over two half days explains what needs to be done when applying for a marketing authorisation in Japan, and the challenges of the application process, from the clinical trial notification to the final marketing authorisation. It will specify what you need to keep in mind when it comes to the specific Japanese CMC requirements and provide useful tips for communication with the authorities.

Who should attend

This unique course addresses the needs of professionals in the healthcare industry involved in registering, exporting and manufacturing pharmaceuticals in Japan.

Members of the following departments in particular will benefit from the speaker's expertise:

  • Business Development
  • Regulatory Affairs
  • Market Access
  • Export

Detailed programme

10:00 - 14:00 each day You may dial in 30 min. before the session

Day one: Brief Introduction to the Japanese pharma market


Composition and procedures of the Japanese regulatory authorities
  • Duties and competences of the MHLW and PMDA

Short break


PMDA consultation
  • Strategic importance
  • Categories of PMDA consultation
  • Strategic and operational considerations

Introduction to ODD, conditional approval and Sakigake pathways
  • Requirements, benefits and timelines for each pathway

Short break


Understanding the culture
  • Japanese and their work and communication culture
  • Doing business with Japanese partners
  • Communication with the authorities

End of day one


Day two: Clinical trial notification in Japan
  • Process
  • Timelines
  • Special considerations

Short break


JNDA
  • Process
  • Timelines
  • Considerations

Short break


CMC requirements and considerations
  • General requirements and considerations
  • Stability and shelf life specifications
  • Japanese master file
  • Foreign manufacturer accreditation
  • Presentation of the data in Module 2

End of seminar


More information

Your benefits

- First-hand information from an expert with outstanding knowledge of the Japanese regulatory system - Two interactive sessions where you can ask questions directly and get useful tips for your regulatory affairs and market access activities

FAQs/What are the system requirements?

You need a reliable Internet connection and a browser. The following Windows browsers are applicable:

  • Internet Explorer 8 onwards
  • Mozilla Firefox
  • Google Chrome

_______________

We recommend you use the Zoom app to connect with your mobile device.
You will need a headset, loudspeakers or a telephone for audio.

_______________

Can I test my equipment beforehand?
Yes, you can check whether everything will work properly on the day of your online training.
Just click the following link to run a test: https://zoom.us/test

_______________

Do I have to use a headset for the online seminar?
No. In addition to all popular microphones and loudspeakers, Zoom also supports dial-in access by telephone. However, working with a headset is much more convenient for online seminars.

How does an online seminar work?

The Zoom webcasts 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, using the chat function.

1. You will receive brief instructions on how to use Zoom online seminars beforehand.
2. Use a headset, loudspeakers or the telephone for audio.
3. Listen to the speaker and follow the presentation.
4. Use the chat function to ask questions.

The benefits of an online seminar

  • Attend the webcasts in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live, using the chat function

This distinguishes our events

Overall score of all evaluations in 2020

Five stars on Trustpilot = Excellent

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