Looking back on the Software Day
Last March, Arlenda organized a full day focused on new regulatory requirements for statistics and the evolution of its software. Among the 30 participants, most were current users but some were companies looking for new opportunities and were able to share user’s experience.
In their feedback, the participants have pointed out in particular
- The usefulness presentation of the new move of the USP toward Total Error
- The information provided along all the day
- The opportunity to provide feedback on the software based on their personal experience
The participants have unanimously requested to repeat this event in the future. So if you have suggestions to help make the next edition a success, send your ideas to email@example.com.
Arlenda would like to thank all the participants to the Software Day organized in Paris on March 17th, 2015 who actively contributed to make this day an amazing learning and sharing opportunity.
Sponsoring the upcoming Annual BEBPA Bioassay Conference 23–25 September 2015, Budapest, Hungary
The Annual BEBPA Bioassay Conferences is the one all experts are attending to brainstorm about opportunities in bioassays and share their experience. Stop by our booth to discuss how Arlenda can provide you with the best applied statistics your assays deserve. One of our scientists will also make a presentation on the potential impact of outliers relative potency determination.
Register now to the Annual BEBPA Bioassay Conference, we can’t wait to see you soon in Budapest!
Walking the wall: Beijing 2015
Perceval Sondag and Bruno Boulanger will be giving a lecture at the Fourth International Symposium on Biopharmaceutical Statistics in Beijing, China from June 29th until July 1st. Their goal is to show how the new USP trends for the validation of analytical procedures aim at filling the gap between the current ICH-Q2 approach and the Quality-by-design (QbD) vision for procedures.
If you’d like to receive the slides of the talk after the conference, send us anemail.
QbD for analytical procedures and Dissolution profiles
Arlenda’s statisticians have recently contributed to a special Issue on Recent Developments in Statistical Approaches for Chemistry and Manufacturing Control (CMC) and Quality-by-Design (QbD) of the Journal of Biopharmaceutical Statistics two papers entitled “Analytical Procedure Validation and the Quality by Design Paradigm” and “A Quality By Design Approach For Longitudinal Quality Attributes” . This again underlines the recognized expertise of Arlenda’s statisticians in applied Bayesian statistics and practical Qbd implementation.
Interested in receiving one of our publications? Send an email firstname.lastname@example.org.
|Arlenda will be celebrating its 12th anniversary on September 22nd 2015. To celebrate 2 more years of successful business, we will host a joint conference* with the ISPE in Leuven.
More information on the website.
*This is a private event, by invitation only.
A warm welcome to Arlenda’s newest member: Steve Novick!
Steve Novick is a senior statistician with Arlenda. He has over 15 years of experience with non-clinical statistics problems having worked previously for Schering-Plough (now Merck) and GlaxoSmithKline.
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