Regulatory Affairs China & ASEAN/Chinese CTD
Current Challenges in Marketing Authorisation and Product Maintenance
- The SDA 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 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.
- Heterogeneity of regions
- Drugs on the Chinese market
- Status and duties of the SDA
- 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 SDA
- ASEAN CTD versus ICH CTD
- Chinese CTD - the specifics
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: 069 2561790
May we also draw your attention to our seminar
"ASEAN & Chinese CTD/eCTD" on 18 March 2020
in the same conference hotel.
You will find detailed information on www.forum-institut.de with web code 2003232.
By attending both courses, you will benefit from a € 190 (+VAT) discount.
Very competent speakers
The seminar is very useful for regulatory affairs manager dealing with ASEAN MAAs
All contents important for the registration process have been discussed
Was a good overview; get answered individual questions
To learn the general regulatory "landscape" in China
Not so many participants, you can ask a lot of questions, speakers habe a lot of experience, that they can share with us
I've been glad to get a full overview on challenges for/with clinical application
Tageting information; clear presenting of regulations
First impression of China Registration, short (but very fast) overview of clinical trials
Good discussions - especially during the breaks
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
I liked most about this event: That a range of topics are covered by the course
Competent and comprehensive overview of current situations
It has provided an overview of registration of medicines in China. Very good speakers, both, due to knowlegde and presentation skills
Our global and local experts will update you every two months with the latest regulatory and legislative developments. Thus, you will always have the essential information and trends in regulatory affairs and pharmacovigilance at your fingertips!
01.11. - 31.10.2020 in Online
This online training programme consisting of three recorded webcasts will train you how to develop documents, compile them and submit an eCTD step by step.
31.12.2019 in Online
This seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide.
13.02.2020 in Frankfurt
After completing this seminar, participants will be aware of the key regulatory requirements when preparing texts, with a greater awareness of the importance of proper English writing, reviewing and proofreading processes.
17. - 18.02.2020 in Frankfurt
CTD Dossier and submission in Asia, the ASEAN countries and especially China discussed in detail at this seminar
18.03.2020 in Frankfurt