Our Sponsors
The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectations
Website https://www.demystifiedsolutions.com/trainingDetails/The-Investigational-Medicinal-Product-Dossier-I |
Edit Freely
Category
Deadline: July 26, 2017 | Date: July 26, 2017
Venue/Country: Online
Updated: 2017-03-10 17:42:02 (GMT+9)
Call For Papers - CFP
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 Should You AttendAll 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 this WebinarUS FDA and EU Agency Orientation / StructureStart –Up and Conducting Clinical Trial ProcessesFollowing Product Registration / Licensing OptionsCompany Strategy- Linking Clinical Trials & Marketing Authorization ApplicationsBalancing Strategy and Long Term Regulatory Cost & MaintenanceIMP Dossier & Comparisons of the US IND to the EU CTA ContentScientific Advice: Member States vs. Pre-IND Meetings with U.S. FDAOrphan Drugs: EU vs. US TreatmentGCP Compliance InspectionsEssentially Similar and Generic ProductsCross-Agency Interactions: Comparing U.S. FDA and EMAEffective Interactions with the Global Regulatory Healthcare AuthoritiesHelpful WebsitesWho Will BenefitThis Webinar will provide invaluable assistance to all personnel inthe 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- ConsultantsFor More Info, Please Click below URL:https://www.demystifiedsolutions.com/trainingDetails/The-Investigational-Medicinal-Product-Dossier-IMPD-EU-CTA-vs-FDA-IND-Comparing-the-Content-and-Agency-Expectations-DEMY051460
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.