The Investigational Medicinal Product Dossier webinar by Compliance4all
- Start Date:
- Tuesday, 24 January, 2017
- End Date:
- Tuesday, 24 January, 2017 11:30am
- Health & Nutrition
Overview: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. 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. Areas Covered In the Session: US FDA and EU Agency Orientation / Structure Start - Up and Conducting Clinical Trial Processes Following Product Registration / Licensing Options Company Strategy- Linking Clinical Trials & Marketing Authorization Applications Who will benefit: This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology and CRO industry conducting Clinical Trials including: Sponsor Senior management Project Managers Clinical Trial Heads Medical writers Speaker Profile:Robert J.
Russell For 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.
161 Mission Falls Lane,
Conference organized by Compliance4ALL
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
- 161 Mission Falls Lane, Suite 216