Overview: This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive for Drugs, Biologics & Combination Products. The course also covers recent updates on EU GCP associated with the Directive, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. Additionally, changes to the Clinical Trial Directive are being contemplated and the Course Director will provide insight into those areas, which may receive modification.
RAPS Approved Webinar on The European Clinical Trial Directive (EUCTD) Date & Time: Course "The European Clinical Trial Directive (EUCTD)" has been pre-approved by RAPS as eligible for up to 1.5 credits Register Now towards a participant's RAC recertification upon full completion. Instructor Profile: Wednesday, July 18, 2012 10:00 AM PDT | 01:00 PM EDT Duration: 90 Minutes Instructor: Robert J. Russell Robert J. Russell President, RJR Consulting, Location: Online Price : $245.00 (for one participant) Inc. For the past 9 years, Bob has been Overview: President of RJR Consulting, Inc. The This course covers the requirements for conducting Clinical Studies company assists the pharmaceutical, across the EU via the requirements of the EU Clinical Trial Directive medical device and biotech for Drugs, Biologics & Combination Products. industries in understanding and complying with International Regulations affecting compliance, The course also covers recent updates on EU GCP associated with new product development, the Directive, the highlights of the new EU Pharmacovigilance manufacturing and quality Directive, as it relates to studies and helpful tips into working with assurance. RJR has offices in the European regulators. Additionally, changes to the Clinical Trial Columbus, OH, Washington, DC, Directive are being contemplated and the Course Director will provide Brussels, Belgium with exclusive insight into those areas, which may receive modification. affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC Areas Covered in the Session: specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals l Overview of the EU and the EU Regulatory Structure and Cordis-Dow medical devices. He l Marketing Authorization Options in the EU has a BS / MS degree in Chemistry. l Overview of the European Union Clinical Trial Directive ...more l 2007 Pediatric Legislation l Processes and Timelines l The Ethics Committee Suggest a Topic More Webinars l Phases of a Clinical Trial l Trial Protocol and Project Management Your Necessity is our Priority l Investigational Medicinal Product Dossier l Standard Operating Procedures l Clinical Trial Authorization Application l Good Clinical Practice l Good Manufacturing Practice l Pharmacovigilance l Handling the end of Clinical Trial l Clinical Trial Databases l European Union vs. The United States l Regulatory Process in the EU l Recent updates to the Directive Click here to register for this webinar Who Will Benefit: l Clinical Operations Staff l Project Team Members l Quality Assurance, Monitors, CRAs l Regulatory Affairs l Investigators & Site Study Staff l Clinical Trial Supply l CROs, Consultants, Insurers It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe
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