This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out effective clinical studies in the U.S. and EU.
Why you should attend: All sponsors, CROs, Sites and auditors of Clinical Research who are involved in pharmaceutical or biological development need to possess the knowledge and be efficient in completing successful applications for their studies. Knowing what is expected of you and "getting-it-right" the first time, will allow faster development of innovative products. This translates to company and personal success and for new therapies to continue to be available to patient populations worldwide.
Areas Covered In the Session:
Who will benefit: This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology and CRO industry conducting Clinical Trials including:
Price List:Live : $245.00Corporate live : $995.00Recorded : $295.00
Phone: 800-447-9407Fax: 302-288-6884 Tuesday, January 17, 201210:00 AM PST | 01:00 PM ESTFor the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.
GlobalCompliancePanel offers a broad range of channels for broadcasting and exchange of information through web based training, web alerts & discussion forums.
GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management. Apart from providing excellent training to compliance professionals by compliance & consulting experts, GlobalCompliancePanel would also focus on providing: