Introducing the Global eProtocol Standard at the CDISC Conference

CDISC extends an invitation to Medical Writers to attend The Interchange Conference in London on the 29th April 2010. The Clinical Data Standards Interchange Consortium (CDISC) is an organisation involved with the development of global data standards. Its success has led to invitations from the FDA and other key regulatory authorities, including EMA, to be involved in standards beyond data. CDISC shares an interest with EMWA in the development of an international standard for the electronic protocol. CDISC formed a working group known as the Protocol Representation Group (PRG) to develop the recently released version 1.0 of the eProtocol. A few EMWA members actively participated in the PRG. If you have not seen the model you can download it here: www.cdisc.org/protocol.

The annual European CDISC Interchange Conference will be held next month at the Lancaster Hotel in central London on the 28th and 29th April. The programme for the second day is being constructed to attract Medical Writers The purpose is to inform medical writers of the activities of the PRG and provide an opportunity to share thoughts with experts on the current eProtocol version. The event offers an opportunity to broaden awareness of topics such as the convergence of clinical data standards with eHealth Records and the initiative to facilitate data sharing - known as SHARE. We also plan to hold an informal roundtable session that has yet to be added to the programme schedule.

#We invite you to take a look at the conference programme at www.cdisc.org/interchange. An attractive single day attendance fee has been arranged for EMWA members and varies according to your company's CDISC membership level. However, please inquire directly to Barry Burnstead This e-mail address is being protected from spam bots, you need JavaScript enabled to view it ) if your company has no association with CDISC or you wish to discuss the programme content in more detail.

Thank you and we look forward to meeting you all in London. E3C (European CDISC Coordinating Committee)