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
Clinical Trial Heads
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.
Compliance4All DBA NetZealous,
Event Link : http://www.compliance4all.com/control/w_product/~product_id=501059LIVE?channel=mailer&camp=Webinar&AdGroup=eventsinamerica_Jan_2017_SEO
Twitter Follow us – https://twitter.com/compliance4all
Facebook Like us – https://www.facebook.com/Compliance4all
LinkedIn Like us – https://www.linkedin.com/company/compliance4all