Last Call to Register for the China Days meeting

EBF Knowledge Exchange Meeting

China Days

11-12 September 2014, Maritim Hotel Berlin, Germany

In a previous post below you will find the final agenda for the China Days meeting which will be held at the Maritim hotel in Berlin from 11-12 September. The meeting is intended for scientists and managers from the areas of bioanalysis, clinical development and clinical operations, quality assurance and regulatory either from the pharmaceutical industry or contract research organisations. The program is constructed to have an optimal exchange of knowledge between scientists from the various disciplines from East and West on doing studies in China.

The costs for this unique meeting are 320 euro, including a meeting package, refreshments, lunch and a cocktail reception. To register go to http://knex2014.europeanbioanalysisforum.eu/Registration/ and follow the link to our secure registration system. Note that registration via the website closes on 7 September and that thereafter only on-site registration in cash is possible. The fee for on-site registration is 500 euro. 

Detailed information on the meeting can be found at the conference website: http://knex2014.europeanbioanalysisforum.eu

With kind regards and looking forward to see you in Berlin, 

On behalf of the EBF and CBF

Margarete Brudny-Kloeppel and Peter van Amsterdam

EBF – Knowledge Exchange

knex@europeanbioanalysisforum.eu 

http://knex2014.europeanbioanalysisforum.eu

Agenda China Days "Meet the Dragon" EBF meeting

Day 1 – Thusday 11 September 2014

09:00 – 11:00      Registration

11:00 – 11:05      Welcome

11:05     13:00     Doing business in China

·         Christian Goedel (SinaLingua)
Cultural awareness: things can be confusing, pitfalls, keeping face, etiquette

·         Yang Liu (Yang Liu Design)
East meets West – Yang Liu’s personal experience on cultural differences

·         Discussion

13:00 – 14:00      Lunch

14:00 – 15:30      Quality systems and Regulatory Processes

·         Jianan Wang (CFDA)
Submissions and inspections

·         Andrew Gray (MHRA)
Is GLP an appropriate standard for laboratories that analyse samples from human clinical trials? – A European perspective

·         Philip Timmerman (Janssen R&D)
Bioanalysis in China: working in the intersection of global regulations and OECD-GLP

·         Discussion

15:30 – 16:00      Tea Break

16:00 - 18:00       Bioanalytical Guidelines

·         Daniel Tan (ICON)
Introduction

·         Dafang Zhong (Shanghai Institute of Materia Medica)
Guideline on bioanalytical method validation in China

·         Daniel Tang (ICON)
CBF activities and involvement in guideline conception and review

·         Discussion

18:00 – 19:00      Reception

Day 2 – Wednesday 12 September

8:30 – 10:30        Clinical studies

·         Peter van Amsterdam (Abbott Established Pharmaceuticals Division)
Introduction to Clinical Trial Applications

·         Pei Hu (Peking Union Medical College Hospital)
Early Phase clinical studies

·         Huafang Li (Shanghai Mental Health Center)
Late Phase Clinical Trials

·         Discussion

10:30 – 11:00      Coffee Break

11:00 – 12:50      Learning by doing

·         Margarete Brudny-Klöppel (Bayer Pharma AG)
How to get the business started

·         Fan Ji (Covance)
Operational and Compliance challenges of setting up Bioanalytical Lab in China

·         Johanna Beekman (Bayer Pharma AG)
Bayer’s experience in sample exportation from China

·         TBD
Central lab perspective

·         Discussion

12:50 – 13:00      Reflections and Close out

13:00 – 14:00      Lunch

China Days meeting: Request for input

Our speakers of the clinical studies session are interested to learn from you which aspects, which questions, you would like them to address in their presentations. It specifically concerns these two talks:

• Early Phase clinical studies (Pei Hu, Peking Union Medical College Hospital)
• Late Phase clinical studies (Huafang Li, Shanghai Mental Health Center)

Please send your questions to knex@europeanbioanalysisforum.eu so that we can help the speakers building an even better program. Many thanks in advance

Updated agenda of the EBF/CBF 'China Days - Meet the Dragon' meeting

CBF-EBF joint sympoisum: Meet the Dragon

EBF will organize in collaboration with the China Bioanalysis Forum its first Knowledge Exchange Days, a new meeting format which will be organized in cooperation with another partner. The purpose is to reach out to a broader community, not only to the bioanalytical area but also cross link with other interfaces.


Purpose of the Knowledge Exchange Days – "Meet the Dragon"
These days are intended to focus on the interaction between European and Chinese specialists with activities in bioanalysis, clinical pharmacology, clinical operations, quality assurance or regulated affaires. Learning from each other and exchanging practical experiences from day-to-day business is in the focus of these days order to achieve a better common understanding.


Who should attend?
Experts from bioanalysis, clinical pharmacology, clinical operations, quality assurance or regulated affaires from the pharmaceutical industry, contract research organizations, academia, and inspectorates.


Preliminary Agenda
* Doing business in China
* Quality systems
* Bioanalytical Guidelines
* Clinical studies
* Learning by doing – Sample import / export procedures and other experiences

Venue, date and duration
Scandic Berlin Potsdamer Platz, Berlin, Germany - 11-12 September 2014 - 1.5 days



Focus Workshop: Standardized Lab Manual - Call for Registration

Final Draft Program DBS Workshop

The program of this two day EBF workshop in Brussels on the value and use of Dried Blood Spots is approaching its completion. The meeting will start at 8:30 on Thursday 17 June and will close at 14:30 on Friday 18 June.

Sessions:
- DBS in the non regulated environment
- Combined poster & tutorial
- Combined toxicology & regulatory/QA aspects
- Bioanalytical & DBS: applications
- Clinical environment
- Bioanalytical & DBS: tools

The detailed final draft can be downloaded from the conference site.

Connecting Strategies on Dried Blood Spots

The EBF workshop on Dried Blood Spots - 17-18 June in Brussels - is reaching the final stages of the setting-up phase.

Next to the 'call for sponsors' and 'call for speakers' (see previous posts) a full detailed announcement of the meeting is now ready for viewing and download: final announcement

For further information see our dedicated site to this conference: http://sites.google.com/site/ebfdbs/

Conference email address: dbs.brussels.2010@gmail.com