Overview: This session 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, 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.

Product examples will be discussed to illustrate effective filing techniques and when Full vs. Abridged applications will be required. The Course will link the requirements of the EU Clinical Trial Directive and discuss when existing clinical data might be sufficient to file. Related ICH compliant requirements such as GCP and GMP will enter the licensing approval process. Common issues that have caused difficulties for pharmaceutical firms will be discussed. Course content will explain how the EU interacts with national regulatory agencies and how companies can best address the conflicts that sometimes arise.

Learning Objectives: This webinar is designed to provide an overview of the regulatory environment throughout Europe and will provide training in:
How to efficiently initiate trials
How to link the strategy of Country Selection to an ultimate EU Licensing Plan
Efficiently implementing studies via project teams and CROs at the National and multi-state level
How to stay compliant…..What can make the difference in your data passing Regulatory scrutiny.
Related area-GCP and PV-reporting updates
EUCTD vs. FDA Regulations

Areas Covered in the Session:
EU Agency Regulatory Structure
Registration Options
Company Strategy- Linking Clinical Trials & Marketing Authorization Applications
Balancing Strategy and Regulatory Cost/Maintenance
2007 Pediatric Legislation Overview
IMP Dossier- EU Expectations and Comparison of CTA to IND Applications
Registration Procedures
Mutual Recognition vs. Centralized Procedure
Abridged Applications
Variations
Labeling & Packaging Leaflet Requirements
Changes to Marketed Products
Maintaining Your License: Renewals
Decision Making Process
Review of Regulatory Authorities
International, Regional, and Local laws applicable for the European Union
Member State Analysis of Applicable Regulations
Political Implications of the Regulations
Compare/Contrast EMEA and the FDA procedures
How and When to Influence the Regulatory Process
Using Regulations / Regulatory Contacts to Your Advantage

Who Will Benefit:
Regulatory personnel
Administrative staff
Compliance Professionals
Sales or general management
Clinical Research Professionals

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. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com