2020-12-07 2021-12-08 , Online Online, 1.090,- € zzgl. MwSt. Dipl.-Ing. Stefan Fischer https://www.forum-institut.de/seminar/21122501-masterclass-china-medical-device-marketing-authorisation-for-advanced/referenten/21/21_12/21122501-medical-devices-china-market-access-marketing-authorisation_fischer-stefan.jpg Masterclass China: Medical Device Marketing Authorisation for Advanced

Would you like to successfully resist on Chinese market for medical devices? Then attend our webcasts and learn more about the new Chinese regulation for medical devices, how to perfect your pre-market registration and post-market surveillance: Our local experts will provide you with brandnew information!

Topics
  • Update your regulatory knowledge
  • Pre-Market Registration (PMR): Minimalise your efforts and costs
  • Acceptance of European registration tests
  • Clinical pathways: From feasibility study report to a clinical trial
  • Perfect your cooperation with your NMPA legal agent
  • Chinese IFU and label
Aims and objectives
China for advanced: Get your deep dive in latest regulatory changes, optimisation of PMR and Chinese post-market surveillance system.

The two webcasts will provide detailed updates about recent regulatory changes in China - including the new medical device law which came into force on 1st June. Last, but not in least, our local experts will address the PMS and related change management with many examples.

Questions and discussions are explicitly welcome. Take advantage of the interactive opportunity to talk directly to local experts during the Q&A sessions.
Who should attend

The webcasts are aimed at specialists and managers in the medical device and IVD industry who are managing medical device marketing authorisation in China. Good knowledge of the Chinese medical device market and its legal framework is an important prerequisite. This online course is of particular interest for the following departments:

  • Regulatory, clinical and quality affairs
  • Strategy & corporate development
  • Product management
  • Distribution and sales

Basic knowledge on medical device marketing authorisation in China is a prerequiste for the training.

Masterclass China: Medical Device Market Authorisation for Advanced

Masterclass China

Medical Device Market Authorisation for Advanced: Pre-Market Registration and Post-Market Surveillance in China for European medical device and MedTech companies

Benefits
  • Two Webcasts
    • Virtual seminar room
    • Discussion and questions possible
    • Chat function
  • Experts with local know-how
  • We follow the IMI quality criteria

Webcode 21122501

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JETZT Buchen

Referenten


Alles auf einen Blick

Termin

07. - 08.12.2021

07. - 08.12.2021

Zeitraum

Two webcasts on 7-8 Dec 2021; 9 - 12...

Two webcasts on 7-8 Dec 2021; 9 - 12 am CET
Veranstaltungsort

Online

Online

Gebühr
Ihr Ansprechpartner

Antje Bauer
Conference Manager

+49 6221 500-655
a.bauer@forum-institut.de

Details

Would you like to successfully resist on Chinese market for medical devices? Then attend our webcasts and learn more about the new Chinese regulation for medical devices, how to perfect your pre-market registration and post-market surveillance: Our local experts will provide you with brandnew information!

Topics
  • Update your regulatory knowledge
  • Pre-Market Registration (PMR): Minimalise your efforts and costs
  • Acceptance of European registration tests
  • Clinical pathways: From feasibility study report to a clinical trial
  • Perfect your cooperation with your NMPA legal agent
  • Chinese IFU and label
Aims and objectives

China for advanced: Get your deep dive in latest regulatory changes, optimisation of PMR and Chinese post-market surveillance system.

The two webcasts will provide detailed updates about recent regulatory changes in China - including the new medical device law which came into force on 1st June. Last, but not in least, our local experts will address the PMS and related change management with many examples.

Questions and discussions are explicitly welcome. Take advantage of the interactive opportunity to talk directly to local experts during the Q&A sessions.

Who should attend

The webcasts are aimed at specialists and managers in the medical device and IVD industry who are managing medical device marketing authorisation in China. Good knowledge of the Chinese medical device market and its legal framework is an important prerequisite. This online course is of particular interest for the following departments:

  • Regulatory, clinical and quality affairs
  • Strategy & corporate development
  • Product management
  • Distribution and sales

Basic knowledge on medical device marketing authorisation in China is a prerequiste for the training.

Detailed programme

Two webcasts on 7-8 Dec 2021; 9 - 12 am CET

7 December
9am - 9am15 Welcome
  • with a short introduction round at the beginning. Each participant could briefly share information about their company and their past experience in China
9am15 - approx.12am

Pre-Market Registration (PMR)

  • Products Technical Requirement (PTR): How to write the PTR to minimalize the efforts and costs of change management
  • Registration tests: What must be done in China and what can be done in your own country
  • Clinical pathways
    • From feasibility study report (FSR) to a clinical evaluation report (CER) to a clinical trial: How to find the best pathway and strategy for your individual product?
  • In-depth analysis: How to accelerate the complete process of registration.

8 December
9am - 9am5 Welcome

9am5 - approx. 12am

Post-Market Surveillance (PMS)
  • Legal agent: What must they do for you in China and how can you cooperate
  • Chinese instruction for use (IFU) and label: Who is responsible and how to manage
  • Change management: Systematic analyzation of different change types and examples
  • Random sampling test in China: Facts and trends
  • Adverse Event (AE): How can you establish a system to manage AE

End of the webcasts
We have prepared an online test for you to test your knowledge.
Once you have taken this test, you will have online access to your certificate.

You will find the online test on your learning platform, for which we will send you separate access data.

Further information

Your advantage

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

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 it 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. 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. Use the chat function to ask questions.

Questions?

The participants are warmly invited to also contribute their own experiences for a thorough exchange! Please send your topic at least 10 working days before the start of the webcasts to Ute Akunzius-Jehn - u.akunzius-jehn@forum-institut.de.

This distinguishes our events

Overall score of all evaluations in 2020

Five stars on Trustpilot = Excellent

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Our international course portfolio

Are you interested in our international continuous education programme? We provide a variety of specialised courses.

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Our international course portfolio
List of abbreviations

Many abbreviations are used in all regulatory areas. Download the list of the most important ones.

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