The EU Clinical Trial Regulation + EU Filings & Registrations 2017

Course "The EU Clinical Trial Regulation + EU Filings & Registrations" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive and the impending changes coming to the EU through the EU Clinical Trial Regulation (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the new regulatory framework, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. Additionally, the seminar will cover the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing].

This course covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States [and EEA], as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway.

Location: Zurich, Switzerland Date:  November 2nd & 3rd, 2017 and Time: 9:00 AM to 6:00 PM

Venue:   Hilton Zurich Airport   Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50

Price:

Price: $1,695.00 (Seminar Fee for One Delegate)

Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*

Register now and save $200. (Early Bird)

Until September 15, Early Bird Price: $1,695.00 From September 16 to October 31, Regular Price: $1,895.00

Register for 10 attendees   Price: $9,322.00   $16,950.00 You Save: $7,628.00 (45%)*

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

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Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901354SEMINAR?medtechiq-November-2017-SEO

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