; PharmaFORUM Webcast Biologics
2022-01-24 2022-01-24 , Online Online, 1.800,- € plus tax Yingying Liu https://www.forum-institut.com/seminar/22022490-pharmaforum-webcast-biologics-marketing-authorisation-in-china-focus-on-cmc-part-i/referenten/22/22_02/22022490-pharmaforum-webcast-biologics_liu-yingying.jpg PharmaFORUM Webcast Biologics "Marketing authorisation in China: Focus on CMC ("Part I")"

Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.

Topics
  • Marketing authorization application (MAA), accelerated approval pathways, timeline
  • - CMC requirements for MAA approval, include but not limit:
    - CMC changes management during clinical trial - Registration testing and inspection - Bundle review regulation for APIs, excipients and packaging materials ('China DMF') - Compliance with Chinse pharmacopoeia
  • Post-approval CMC change management
Aims and objectives
Do you work with biologics? Then, we would like to invite you to join our live webcast series.
Industry and authority experts will provide you with the latest information on the current challenges in analytics, development, quality and regulatory affairs (pre- and post-authorisation phases) of biologics every monthly. Most webcasts are specifically focused on CMC while addressing topics at the interface Quality and Regulatory Affairs.
You will meet our experts in a virtual conference room and share your experiences live. Each meeting will be held as a 1.5 to 2-hour webcast, presenting the latest news with supporting presentation slides. To be best prepared, you will be able to download the complete presentation documents prior to each webcast.
Are you unable to attend one of the webcasts? No problem! Following each live meeting, you will be able to retrieve the recorded webcast (audio track and presentation) from our eLearning Centre, using your personal password. This allows you to review each presentation at any time and as often as you like.
Who should attend

This webcast series addresses the needs of managers in the biopharmaceutical industry needing to keep up to date with development, quality, analytics and regulatory affairs, in particular with CMC related topics.

22022490 PharmaFORUM Webcast Biologics

PharmaFORUM
Webcast Biologics

Benefits
  • Meet the biotech experts
  • High-level knowledge transfer
  • One live webcast every month
  • Unable to join live? Retrieve the recording from the archive
  • We are following the IMI quality criteria

Webcode 22022490

Book now

JETZT Buchen

Speaker


Everything at a glance

Appointment

anytime

anytime

Period

Starts at 14:00 CET

Starts at 14:00 CET
Venue

Online

Online

Fee
Ihr Ansprechpartner

Dr. Birgit Wessels
Conference Manager

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

Details

Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.

Topics
  • Marketing authorization application (MAA), accelerated approval pathways, timeline
  • - CMC requirements for MAA approval, include but not limit:
    - CMC changes management during clinical trial - Registration testing and inspection - Bundle review regulation for APIs, excipients and packaging materials ('China DMF') - Compliance with Chinse pharmacopoeia
  • Post-approval CMC change management
Aims and objectives

Do you work with biologics? Then, we would like to invite you to join our live webcast series.
Industry and authority experts will provide you with the latest information on the current challenges in analytics, development, quality and regulatory affairs (pre- and post-authorisation phases) of biologics every monthly. Most webcasts are specifically focused on CMC while addressing topics at the interface Quality and Regulatory Affairs.
You will meet our experts in a virtual conference room and share your experiences live. Each meeting will be held as a 1.5 to 2-hour webcast, presenting the latest news with supporting presentation slides. To be best prepared, you will be able to download the complete presentation documents prior to each webcast.
Are you unable to attend one of the webcasts? No problem! Following each live meeting, you will be able to retrieve the recorded webcast (audio track and presentation) from our eLearning Centre, using your personal password. This allows you to review each presentation at any time and as often as you like.

Who should attend

This webcast series addresses the needs of managers in the biopharmaceutical industry needing to keep up to date with development, quality, analytics and regulatory affairs, in particular with CMC related topics.

Your benefits

More details

Find all the details regarding the programme, experts and technical requirements at
www.online-forum-institut.de/biologics_webcast

This distinguishes our events

Overall score of all evaluations in 2021

Five stars on Trustpilot = Excellent

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Technical requirements

Here you can find the technical requirements for our online events that must be met.

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Technical requirements
e-Learning - Click and learn

We provide flexible education and training with high-quality e-Learning programmes for several topics.

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Quality guaranteed!

Your feedback produced as result of 1.8 in 2021. Thank you!

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