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.
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 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.
- Glossary of Terms.
