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32676 Conferences

EU IMPD vs. US IND: Comparing the Content and Agency Expectations

Added by Referral on 2010-09-17

Conference Dates:

Start Date Start Date: 2010-09-21
Last Date Last Day: 2010-09-21

Conference Contact Info:

Contact Person Contact Person: admin
Email Email: admin@complianceonline.com
Address Address: 2600 E. Bayshore Road, Online Event, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

This training on EU IMPD & US IND will help you in understanding the clinical trial and registration / licensing differences between US and EU as per EU IMPD and US IND and cover the guidance document explaining data expectations in Phase I, II, III and licensing.

Why Should You Attend:

This course specifically focuses on the nuances and real differences between two ICH areas of the World: the U.S. and the EU. We will cover every aspect of running clinical studies, including what can be harmonized and used elsewhere globally and talk about the implications of receiving Scientific Advice, registering Orphan Drugs and comparative GCP Inspections. We will also cover a detailed Guidance Document which explains the data expectations and known IMP information expected at Phase I, II, III and licensing.

Learning Objectives:

This course is designed to provide an overview of the Clinical Trial start-up procedures by area and then move into the dossier requirement differences between the U.S. and across the EU.
Guidance documents will be reviewed which highlight the EU expectations of the IMP whether a sponsor is entering a clinical trial or filing for licensing.
This Course will give both a good detailed overview of clinical trial and registration processes and dig into the technical details expected by FDA and the Competent Authorities across the EU.

Areas Covered in the Seminar:

US FDA and EU Agency Orientation / Structure.
Start ľUp 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.
Glossary of Terms.
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