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Legal Disclosure

Information in accordance with section 5 TMG

Katja Glaß (PhUSE member)
Biesdorfer Weg 17a
12683 Berlin
Germany

Contact

E-Mail: katja.glass@phuse.com
Homepage: www.phusewiki.org

Disclaimer

Accountability for content
The contents of our pages have been created with the utmost care. However, we cannot guarantee the contents' accuracy, completeness or topicality. According to statutory provisions, we are furthermore responsible for our own content on these web pages. In this context, please note that we are accordingly not obliged to monitor merely the transmitted or saved information of third parties, or investigate circumstances pointing to illegal activity. Our obligations to remove or block the use of information under generally applicable laws remain unaffected by this as per §§ 8 to 10 of the Telemedia Act (TMG).

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Responsibility for the content of external links (to web pages of third parties) lies solely with the operators of the linked pages. No violations were evident to us at the time of linking. Should any legal infringement become known to us, we will remove the respective link immediately.

Copyright
Our web pages and their contents are subject to German copyright law. Unless expressly permitted by law (§ 44a et seq. of the copyright law), every form of utilizing, reproducing or processing works subject to copyright protection on our web pages requires the prior consent of the respective owner of the rights. Individual reproductions of a work are allowed only for private use, so must not serve either directly or indirectly for earnings. Unauthorized utilization of copyrighted works is punishable (§ 106 of the copyright law).

Privacy Statement

General

Your personal data (e.g. favorites, title, name) are processed by us only in accordance with the provisions of German data privacy laws. The following provisions describe the type, scope and purpose of collecting, processing and utilizing personal data. This data privacy policy applies only to our web pages. If links on our pages route you to other pages, please inquire there about how your data are handled in such cases.

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Disclosure

According to the Federal Data Protection Act, you have a right to free-of-charge information about your stored data, and possibly entitlement to correction, blocking or deletion of such data. Inquiries can be directed to the following e-mail addresses: ( katja.glass@phuse.com )
Annex 1 to Article 246 § 2 Section 3 Clause 1 of the Introductory Act to the German Civil Code (EGBGB)

Special Events

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PhUSE SCRIPTATHON

Sunday, 12th October, 14:00 - 17:30


Following the success at the 2014 PhUSE CSS, the PhUSE Annual Conference will feature a “Scriptathon”.

This hands-on opportunity will help add content to the PhUSE CSS Standard Scripts Working Group code repository. Scriptathon participants (pre-registered) will collaborate to create programs using languages like SAS and R.

Output of the Scriptathon will be added to the PhUSE Code Repository and will be publically accessible for Regulatory Reviewers and Clinical Data Scientists across the industry.

Targets will be selected from the PhUSE CSS White Papers on Demographics, Outliers and Adverse Events and there will be the opportunity to create SDTM scripts based on Rave extracts.

What You Need

While we are expecting participants with strong programming skills and good experience, the technical requirements are minimal.

Participants will need a laptop with a browser (Chrome, Safari or Firefox ONLY) and will work on three cloud based programming environments:
Michael Carniello (Astellas)

Location: Bartholomew Room

Special Events

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Data De-Identification

Sunday 12th October - 15:00 - 17:00


Last year the European Medical Agency (EMA) released a draft policy on the publication and access to de-identified clinical-trial data for a 3 month public consultation. A PhUSE working group provided consolidated industry comments on behalf of the PhUSE membership.

The EMA have now internally agreed the framework of the policy and it will be finalised and approved mid-July and will be made effective on October 1st, 2014. Ahead of this guidance and forthcoming EU law, during the last year, many pharmaceutical companies have already started to prepare their own de-identified data to deal with research requests.

Realising the impact that this will have on our industry and in the lack of industry specific standard on what rules to use when de-identifying data, the PhUSE Board recently agreed to set up a Working Group that will drive an industry set of de-identified rules that are based on the CDISC SDTM data model.

Various members from Pharmaceuticals, CROs, Academia and Software companies have joined this group and are currently planning scope and deliverables. They have been working together virtually since July and will meet at the Annual Conference to review progress and discuss details of the deliverables.

Jean-Marc Ferran (Qualiance)


Location: Harpley Room

Special Events

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Speakers Meeting

Sunday 12th October - 18:00


Dear PhUSE Speakers,
please join the PhUSE speakers meeting to get know the last details for the presentations and to meet your stream chair and co-chair.



Location: Warwick/Salisbury

Special Events

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Welcome Mixer

Sunday 12th October - 19:30


Dear PhUSE attendees,
please join the PhUSE welcome event to meet the PhUSE community and have a nice evening.

Sponsored by:


Location: Foyer C, 1st Floor

Special Events

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Gala Dinner

Monday 13th October - 19:00


Please join the Gala Dinner at the Grange St. Paul's Hotel to meet the PhUSE community.

The coaches will pick up the attendees from the Hotel at 19:00. The return coaches go between 22.30–00.30

Sponsored by:

Special Events

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Poster Session

Tuesday 14th October - 18:00 - 19:00


The Poster Stream cover a wide variety of topics in a poster board rather than a formal lecture. Posters are ideal for presentations that include graphics, source code, statistical concepts or thought-provoking concepts that invite participants to review at their own pace.

Sponsored by:


Location: Exhibitor Area