FORUM INSTITUT
FORUM · Institut für Management GmbH
Vangerowstraße 18
69115 Heidelberg
Email: service@forum-institut.de
Phone: +49 6221 500-500
Fax: +49 6221 500-505
Course Regulatory Affairs China
Regulatory Affairs China
Marketing Authorisation and
Clinical Development
2019-03-13 2019-03-13 Hilton Mainz City Münsterstr. 11 55116 Mainz info.mainz-city@hilton.com +49 6131 27 80 +49 6131 27 85 67

Regulatory Affairs China

Current Challenges in Marketing Authorisation and Product Maintenance

Two experts will give you an in-depth update on your duties with regard to accepted clinical trial data, dossier submission and the post-approval processes.
Topics
  • The SDA and further authorities
  • Essential documents for a new application
  • Clinical trial application
  • Maintenance duties

This distinguishes our event

86%
Overall impression: 86% of the participants' feedback was very good or good (March 2018)
86%
Course content: 86 % of the participants' feedback was very good or good (March 2018)
86%
Practical benefit: 86 % of the participants' feedback was very good or good (March 2018)

Aims and objectives

After 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).

Who should attend
This seminar addresses the needs of regulatory affairs managers dealing with marketing authorisations in China or the ASEAN countries.

It is also helpful for regulatory / medical affairs managers and business development people who aim to enter one of those markets with their products.
Your speakers
Dr. Alan A. Chalmers
Pharma International, Innovation Centre, SWITZERLAND

Dr. Mónica Dressler-Meyer
Consultant for Regulatory Affairs, Binningen, SWITZERLAND


Go forward

Pharma Webcast Global RA & PV

Pharma FORUM Webcast International

We would like to invite you to join our live webcasts, where local regulatory affairs and vigilance experts will inform you every two months of the latest news and trends in global marketing authorisation and drug safety.

Details

ASEAN & Chinese CTD/eCTD

Booking Option:

ASEAN & Chinese CTD/eCTD

  • ASEAN CTD; Chinese CTD
  • CMC, efficacy and safety - data compilation
  • National specialities in the various ASEAN countries
  • eCTD and eSubmission

Details

More on our quality criteria

Quality guaranteed!

IMI (Innovative Medicines Initiative) defined quality criteria for professional training and education. We follow these criteria and, as a signatory, we are an active partner in further developing and optimising the quality standards.

An aggregate evaluation of participants' feedback on all FORUM's healthcare training courses (evaluation period from 10.2017 - 09.2018 produced a result of 1.6 (based on a school grading system of 1-6).

Details