4 February 2010. Fraud and Non-Compliance in Clinical Research. Presented by Christine Brouillard-Pierce, Director, CAQ Solutions Inc. What a wonderful turnout for a fabulous meeting! Chris spoke about Fraud and how Non-Compliance can often lead to Fraud. The hour flew by as the presentation was captivating. Over dinner, discussions continued as we have all been exposed to Fraud or Non-Compliance in our careers. A very important topic presented extremely well!
This is a link to a new proposed rule re reporting of fraud. http://www.fdanews.com/ext/files/2010-03123_PI.pdf
2 May 2009 Electronic Data Capture Systems – What is going on today and tomorrow? presented by Jonathan Andrus, VP Data and Study Operations Bioclinica It was great to see Jonathan present again after 3 years. And quite a few updates on the EDC end as well. As usual, the presentation was lively and very interactive. We all learned some new acronyms which we can use with our Data Management people within our companies! To see photos, follow this link! http://www.flickr.com/photos/35116039@N05/sets/72157617921090174/
2 April 2009 Health Canada GCP Inspections in Canada:a Review presented by Alicja Kasina What a turnout for this meeting! Alicja gave us a great review of the inpsection findings over the years in Canada. The question period was lively with many questions. And we learned a lot of information. For example, there is now a Pre-Inspection Package that is sent to inspectees prior to their inspection as an initiative to make the inspection process more formal and transparent. It is not yet on the HC web page but keep looking as it will be there soon! Thanks to everyone who attended!
2 March 2009
Clinical Trials in Canada, a Regulatory Review presented by Pat Jones
Wonderful meeting. Pat gave a great overview of the regulatory perspective of clinical trials in Canada. She also had loads of real life examples which makes it so much easier to remember all the data. There were a lot of people in attendance and the questions had to be cut short to allow dinner to be served. Always a good sign.
To see photos from the meeting, follow this link to flcker
http://www.flickr.com/photos/35116039@N05/?saved=1
2 February 2009
GCPs in 2009 presented by Denyse Tyndall, Director of D. Tyndall and Associates Inc.
What a great meeting! Denyse presented examples of audit observations, some quite astounding! But then she also presented the CAPA (Corrective and Preventive Action) for each of these findings. This made for some interesting discussions and a lot of oohs and ahhs from the audience. Many of the findings that drive Denyse crazy really are incredible. We all had a few laughs but certainly learned a lot. And the discussions continued over a delicious dinner and a glass of wine. Thanks to Denyse!
Follow this link to see photos from the meeting!
http://www.flickr.com/photos/35116039@N05/sets/72157613401123667/