The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectations - Webinar By GlobalCompliancePanel November 8, 2012

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. 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:
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
Balancing Strategy and Long Term Regulatory Cost & Maintenance
IMP Dossier & Comparisons of the US IND to the EU CTA Content
Scientific Advice: Member States vs. Pre-IND Meetings with U.S. FDA
Orphan Drugs: EU vs. US Treatment
GCP Compliance Inspections
Essentially Similar and Generic Products
Cross-Agency Interactions: Comparing U.S. FDA and EMA
Effective Interactions with the Global Regulatory Healthcare Authorities
Helpful Websites

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
Project Managers
CRAs and CRCs
QA / Compliance personnel
Investigators
Clinical Research Scientists
QA / QC Auditors and Staff
Consultants

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. 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.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

[email protected]
http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Event Link - http://bit.ly/PCY9JT