World Conference Calendar

33818 Conferences

2010 Changes to the EU Variation Rules, Classifications and Submittal Requirements

Added by Referral on 2010-08-12

Conference Dates:

Start Date Start Date: 2010-08-30
Last Date Last Day: 2010-08-30

Conference Contact Info:

Contact Person Contact Person: admin
Email Email:
Address Address: 2600 E. Bayshore Road, Palo Alto, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

This European Regulatory webinar is designed to provide an overview on the changes to the variation rules, classifications and filing requirements for all active pharmaceutical, biologics and orphan drug licenses in the EU.

Areas Covered in the Seminar:

The European Regulatory Structure.
How the Commission and Individual Member States within Europe interact.
New Rule Changes for Type IA, IB and Type II Variations.
New Variation Application Submittal Form.
New Variation Guidance Document, including conditions to be met and necessary appended documents per the rule.
New Processing Times for EU variations.
New Bundling Rules & Fee Payments for EU Variation Submittals.
License Holders’ Responsibilities.
Understanding the Concerns/Issues of European Regulatory Personnel.
How to Negotiate with the Regulatory Agencies.

For More Details:
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