Fortbildung bei der DGRA e.V.

Programme October 14, 2014:
9.00 – 09:30 a.m.	I. Introduction: Asian Market •    Defintion, characterization Dr. Michael Gebauer
09.30 – 10:30 a.m:	II. Requirements of Clincial Trials //Scientific advice •    Where and why to conduct clinical studies in Asia •    Ethnical Sensitivity (ICH E5 in non ICH countries) •    Regulatory hurdles (CTA/IND; processes) •    Scientific Advice in Asia NN
10:30 – 11:00 a.m.	Coffee break
11:00 – 12:30 a.m.	III. Quality/ Stability Requirements •    CMC documentation (is ICH QOS + M3 sufficient?) •    Special Attention for stability data •    [SMF/PMF] •    PIC´s [asian members), Inspections •    Samples and analytical tests Dr. Manuel Zahn
12:30 – 01:30 p.m.	Lunch break
01:30 – 03:00 p.m.	IV. Certificates •    CPP´s (Certificate of Pharmaceutical Product) •    Other Autorisations [PoA´s], Translations •    Successful submission NN
03:00 – 03:30 p.m.	Coffee break
03:30 – 05:30 p.m.	V. Generic Marketing Authorization •    Regulatory Enviroment, Scientific Advice, Procedures NN
Programme October 15, 2014:
09:00 – 09.45 a.m.	VII Marketing Authorization in China •    CFDA, CDE •    Drug classification (category I-IV) RA processes, timelines •    IDL  vs local manufacture Dr. Santiago Figueroa Pérez
09.45 – 10.00 a.m.	Break
10.00 - 11.00 a.m.	VII Marketing Authorization in China (continued)
11.00 – 12:00  p.m	VIII. Marketing Authorization in India •    CDSCO, DCG(I) •    General registration processes, timelines •    Impact of recent developments on regulatory processes (Clinical Trials, Patents) Xenia Freifrau von Maltzan
12:15 – 01:15 p.m.	Lunch break
01.15 – 02:30  p.m.	IX. Marketing Authorization in Taiwan •    T-FDA, CDE •    Bridging Evaluation •    PMF / Manufacturer inspections Dr. Hsueh-Yung (Mary) Tai, TFDA
02:30– 2:45 p.m.	Break
02:45 -  03.45 p.m.	X. Marketing Authorization in South Korea •    MFDS (Ministry of Food and Drug Safety) •    Korean Bridging guideline •    IND and NDA, Re-examination Dr. Michael Gebauer
03:45– 4:00 p.m.	Coffee break
04.00– 04:30 p.m.	XI. ASEAN · ASEAN harmonization approach · ASEAN guidelines, ACTD Xenia Freifrau von Maltzan

Conference language: English

€ 750 for DGRA Members and M.D.R.A. students course 15.
Number of participants is limited.

Up to two weeks before the first day of the school (September 30th 2014): € 50;
up to one week before the first day of the school (October 7th 2014): 50% of fee;
late cancellations: full conference fee if a substitute participant (DGRA member) cannot be put forward.
In the event of cancellation by the organizer, any fees already paid will be fully reimbursed.

With the cooperation of DGRA e.V. and the Deutsche Bahn you travel relaxed and comfortably to your DGRA education and training events in 2014. The price for your ticket for a return trip to Bonn is 99 € (2nd class) and 159 € (1st class). Detailed information and booking options for this offer can be found here.