ComplianceOnline

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

Instructor: Robert J Russell
Product ID: 701739
  • Duration: 60 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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.

Why Should You Attend:
In January 2010, the EU implemented changes in the process for filing variations for all pharmaceuticals and biologics licensed in any Member State across the EU. These changes encompass the variation rules, classification of "variation type" changes, conditions for filing, the application form and required information needed to maintain compliance.

This live web training will focus on these important changes, and address the structure of the regulatory agencies in the EU and the individual Member States, including the EEA (European Economic Area) countries. Content will include descriptions of the new variation rules, as well as guidance documents for filing variations to the competent authorities on all national, mutual recognition and decentralized licenses.

The course will also cover changes to the variation rules for all centralized licenses through the CHMP/European Medicines Agency (EMA), the new bundling options available to submitters, and the changes to typically classify variations that existed under the old framework of rules.

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.

Who will benefit:

  • Quality and regulatory personnel - whose responsibilities require knowledge of maintaining licenses through the variations process across the EU.
  • Administrative and regulatory staff - responsible for ensuring compliance with regulatory filings/variations processing.
  • Any sales or general management employee - requiring an understanding of how the “conditions” of licenses are updated, what license holders’ requirements are, and the importance of maintaining accurate product licenses across the EU will also benefit.

Instructor Profile:
Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry.

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