2020-12-19 2021-10-21 , Online Online, 2.390,- € zzgl. MwSt. Dr. Alan A. Chalmers https://www.forum-institut.de/seminar/2110231-marketing-authorisation-in-asia/referenten/21/21_10/2110231-course-pharma-marketing-authorisation-in-asia_chalmers-alan-a.jpg Marketing Authorisation in ASIA

Essential know-how on the current regulatory framework of the various countries will be addressed in this seminar.

Topics
  • Current regulatory framework
  • ASEAN: Harmonisation of the Asian drug market?
  • China - guidelines and marketing authorisation
  • Marketing authorisation for NCEs and generics
  • Submission of variations and renewals
  • Communication with the authorities
Aims and objectives
You are interested in receiving and maintaining a marketing authorisation in Asia? Then you shouldn't miss this online-seminar!

After having completed this seminar you have an in-depth insight into the current regulatory framework of the various countries.

Two experts will give you valuable information regarding
  • dossier requirements
  • communication with the authorities
  • marketing authorisation procedures and
  • maintenance duties

and inform you about future developments in the ASEAN region as well as in China.
Who should attend

This seminar will be of benefit to all those working in the pharmaceutical industry and interested in marketing pharmaceuticals in Asia. Especially those working in regulatory affairs and business development will profit from the seminar.

This seminar is restricted to 20 participants.

Course Pharma - Marketing Authorisation in ASIA

Marketing Authorisation in ASIA

China, Indonesia, Hong Kong, Singapore, Thailand, Korea, Malaysia, The Philippines, Vietnam, Taiwan

Benefits
  • Experts with local know-how
  • Including recent changes in legislation in China and Vietnam
  • Time for practical cases
  • We are following the IMI quality criteria

Webcode 2110231

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

19. - 21.10.2021

19. - 21.10.2021

Zeitraum

Day 1: 09:00 - 18:00 Day 2+3: 09:00 ...

Day 1: 09:00 - 18:00 Day 2+3: 09:00 - 17:00
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

Essential know-how on the current regulatory framework of the various countries will be addressed in this seminar.

Topics
  • Current regulatory framework
  • ASEAN: Harmonisation of the Asian drug market?
  • China - guidelines and marketing authorisation
  • Marketing authorisation for NCEs and generics
  • Submission of variations and renewals
  • Communication with the authorities
Aims and objectives

You are interested in receiving and maintaining a marketing authorisation in Asia? Then you shouldn't miss this online-seminar!

After having completed this seminar you have an in-depth insight into the current regulatory framework of the various countries.

Two experts will give you valuable information regarding

  • dossier requirements
  • communication with the authorities
  • marketing authorisation procedures and
  • maintenance duties

and inform you about future developments in the ASEAN region as well as in China.

Who should attend

This seminar will be of benefit to all those working in the pharmaceutical industry and interested in marketing pharmaceuticals in Asia. Especially those working in regulatory affairs and business development will profit from the seminar.

This seminar is restricted to 20 participants.

Detailed programme

Day 1: 09:00 - 18:00 Day 2+3: 09:00 - 17:00
You may dial in 30 min. before the session

Day one: The Asian markets: an overview
  • Commerce in Asia
  • Cultural specialities

ASEAN countries - background information and newest developments
  • Initiatives for the harmonisation of the Asian drug market
  • Newest developments and perspectives in drug registration
  • Conclusions for marketing authorisation in Asia

Marketing authorisation in CHINA
  • Company registration and marketing authorisation
  • Marketing authorisation application for NCEs
  • Variation and renewal procedures
  • Communication and meetings with the authorities
  • Latest changes in 2020 and 2021

Day two: PHILIPPINES
  • Marketing authorisation & maintenance

HONG KONG
  • Marketing authorisation & maintenance

Conditions for a marketing authorisation in TAIWAN
  • Regulatory framework
  • Authority structure
  • Maintenance of the marketing authorisation

KOREA (Republic of Korea/South Korea)
  • Marketing authorisation & maintenance
  • Regulatory Environment

Day three: Regulatory framework in THAILAND
  • Marketing authorisation & maintenance

MALAYSIA
  • Marketing authorisation & maintenance

VIETNAM
  • Marketing authorisation & maintenance
  • Updates following recent changes in legislation

Regulatory framework in INDONESIA
  • Marketing authorisation & maintenance

Requirements in SINGAPORE
  • Marketing authorisation & maintenance

ASEAN countries
  • Future developments in the ASEAN countries

More information

The covered countries

Day one: ASEAN & China Day two: Philippines, Hong Kong, Taiwan, Korea Day three: Thailand, Malaysia, Vietnam, Indonesia, Singapore

Your benefit

  • Detailed information on the current novelties in China and other Asian countries
  • Time for the thorough discussion of the marketing authorisation in Taiwan, South Korea, Thailand, Malaysia, Vietnam, Indonesia, Singapore and much more
  • Specific country wishes? Please let us know!

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 impression: 100 % of the participants' feedback was very good or good (October 2019)

Course content: 100 % of the participants' feedback was very good or good (October 2019)

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Quality guaranteed!

Your feedback produced as result of 1.7 in 2020. Thank you!

Details
More on our quality criteria

Testimonials

This was well received by the participants in October 2019
Impressive on the rich content

Jianhui Sun

SEPTODONT


Both speakers are excellent


It was really very informative and well structured


Good overview, professional and experienced speakers


Informative, gives a deep insight into RA procedures in Asia/ASEAN


Very complex but really usefull. Thanks to speakers