Clinical Data Management – Benefits of Standardization in Establishing CDM Processes

Start Date : May 17, 2018
End Date : May 18, 2018
Time : 9:00 am to6:00 pm

Phone : (800) 447-9407
Email : support@globalcompliancepanel.com

Location :
DoubleTree by Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, PA 19153

Website

Description



Course "Clinical Data Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


Overview:


When new drugs or devices are tested in humans, the data generated by, and related to, these trials is known as clinical data. This data represents a huge investment by the biopharmaceutical or device company and is one of its greatest assets. It is this data that will eventually make a new product both useful as a treatment or therapy and marketable. The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today.


This seminar is based on the current state of regulations and will cover the essential parts of the data management plan, study startup, study conduct, study closeout and study monitoring.





At the end of this class attendees will be able to:





Who Should Attend:





Professional Associations:



Agenda:


Day 1 Schedule




Lecture 1 (90 Mins):


CDM: The Reasons and The Requirements





Lecture 2 (90 Mins):


Elements in Developing a Data Management Plan





Lecture 3 (180 Mins; Afternoon of Day 1):


Study Startup



Day 2 Schedule




Lecture 1 (90 Mins):


Study Conduct





Lecture 2 (90 Mins):


Study Conduct (cont'd)





Lecture 3 (90 Mins):


Study Closeout





Lecture 4 (90 Mins):


Monitoring Visits



Speaker


Angela Bazigos


CEO, Touchstone Technologies Silicon Valley


Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer http://morflearning.com/angelabazigos/. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx Patent on speeding up software compliance https://www.google.com/patents/US8266578. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.


 


Location:  Philadelphia, PA Date: May 17th & 18th, 2018 and Time: 9:00 AM to 6:00 PM


Venue:  WILL BE ANNOUNCED SOON


Price:


Price: $1,295.00 (Seminar Fee for One Delegate)


Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*


Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*


 Register now and save $200. (Early Bird)


Until April 20, Early Bird Price: $1,295.00 From April 20 to May 15, Regular Price: $1,495.00


Sponsorship Program benefits for “Clinical Data Management -Benefits of Standardization in Establishing CDM Processes


” seminar


For More Information- https://www.globalcompliancepanel.com/control/sponsorship 


Contact us today!


NetZealous LLC DBA GlobalCompliancePanel


john.robinson@globalcompliancepanel.com  


support@globalcompliancepanel.com 


Toll free: +1-800-447-9407


Phone: +1-510-584-9661


 Website: http://www.globalcompliancepanel.com


 


Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901738SEMINAR?SEO


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Registration Info

Registration link :   https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901738SEMINAR?may-2018-seo-meetings4doc

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous LLC DBA GlobalCompliancePanel ,
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

Tel: 800-447-9407
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com/


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