Regulatory Affairs China
Current Challenges in Marketing Authorisation and Product Maintenance
- The CFDA and further authorities
- Essential documents for a new application
- Clinical trial application
- Maintenance duties
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 content and dossier type 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 submission 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).
- Heterogeneity of regions
- Drugs on the Chinese market
- Status and duties of the CFDA
- Authorities, agencies and ministries
- National guidelines and legislation and new regulatory requirements
- Raising standards for local generics
- Accelerated marketing authorisation - the posibilities
- Different requirements for various trial types, acceptance of foreign clinical study data
- Proof of efficacy, safety and quality
- Required documents and formats including import and local manufacturing
- Communication with the authorities
- Improving the efficiency of the drug evaluation process within the CFDA
- Variations; licence renewal
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.
Phone: +49 69 427 232-0
Fax: +49 69 427 232-999
May we also draw your attention to our seminar
"ASEAN & Chinese CTD/eCTD" on 15March 2018
in the same conference hotel.
You will find detailed information on www.forum-institut.de with web code 1803231.
By attending both courses, you will benefit from a € 190 (+VAT) discount.
Gute Übersicht mit praktischen und wertvollen Empfehlungen
Good Overview and pratical advices
I got a lot of useful information
A lot of interesting overall informion
Good discussions - especially during the breaks
I liked most about this event: That a range of topics are covered by the course
It has provided an overview of registration of medicines in China. Very good speakers, both, due to knowlegde and presentation skills
It's very practical that it's in English!
Would be great to include more examples
Thank you very much for your input. We will ask the speakers to include more examples in future courses.
Dr Henriette Wolf-Klein, Department Manager Pharma & Healthcare
CHEPLAPHARM Arzneimittel GmbH
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