The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectation

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The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectation - Webinar by GlobalCompliancePanel

Website http://bit.ly/1bblpfU | Edit Freely

Category Webinar, Health, Medical, Pharma, Clinical

Deadline: January 08, 2014 | Date: January 08, 2014

Venue/Country: USA, U.S.A

Updated: 2013-12-03 14:40:14 (GMT+9)

Call For Papers - CFP

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.

Contact Information:

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

Fax: 302-288-6884

webinarsglobalcompliancepanel.com

http://www.globalcompliancepanel.com

Event Link - http://bit.ly/1bblpfU

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.