ASEAN & Chinese CTD/eCTD
Dossier content, format and submission discussed in detail
- ASEAN CTD; Chinese CTD
- CMC, efficacy and safety - data compilation
- National specialities in the various ASEAN countries
- eCTD and eSubmission
This distinguishes our event
Aims and objectivesAfter having completed these two seminar days you are aware of the regulatory novelties in China as well as of the dossier compilation challenges in China and the ASEAN countries.
On day one you will learn in detail the points to consider when applying for the marketing authorisation in China and what to keep in mind during the lifecycle of a licenced product.
Day two focusses on the dossier for marketing authorisations in China and the various ASEAN countries. After having completed day two you know the differences of the various formats and know the current status of eCTD submissions in this region.
Both seminar days can be booked separately. On day two a regulatory affairs understanding of the Chinese market is presumed (and can be obtained on day one).
It is also helpful for regulatory / medical affairs managers and business development people who aim to enter one of those markets with their products.
- ASEAN CTD versus ICH CTD
- Chinese CTD - the specifics at a glance
10:15 Coffee break
- CMC, clinical and preclinical requirements
- Dossier compilation
- Practical cases
- Singapore, Malaysia and Thailand - current efforts
- eCTD in China
17:00 Seminar end
With over 35 years of pharmaceutical industry experience, his main area of expertise lies in pharmaceutical regulatory affairs. He was Head of Regulatory Affairs, Pharma International at Ciba-Geigy/Novartis and has been director of Pharma International regulatory consultancy for more than 10 years.
She has several years‘ experience in regulatory affairs in the Asia-Pacific region, most recently as DRA Manager FE Countries at a Swiss pharmaceutical company.
Telefon: +49 6131 27 80
Fax: +49 6131 27 85 67
May we also draw your attention to our seminar
"Regulatory Affairs China"
on the 13 March 2019 in the same conference hotel.
You will find detailed information on www.forum-institut.de with web code 1803230.
By attending both courses, you will benefit from a € 190 (+VAT) discount
Very good seminar
Thorough overview, lots of details
Information regarding country specific
Cultural and practical reality vs. guidance in China; Expertise of the speakers
Good overview, get individual questions answered
Low participants number - you can alsways ask questions
Speakers with a lot of experience
CHEPLAPHARM Arzneimittel GmbH
A lot of backround information were provided
CHEPLAPHARM Arzneimittel GmbH
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