Pharmaceutical Filings and Registration Procedures
Overview: This session covers the various licensing methods (for drugs, biologics and combination products) by which applicants can file for product licenses (marketing authorisations) 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 and marketing authorisation 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. centralised procedure Abridged applications Variations Labeling and 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. Event Link - http://alturl.com/z6i4f
Date: 22 August 2012 Time: 10:00 AM - 11:30 AM Location: Online Training, Wilmington Cost: Live : $245.00,Corporate live : $495.00,Recorded : $295.00 More info: Online Training
Contact: GlobalCompliancePanel Company name:GlobalCompliancePanel Telephone number: 8004479407 Email address
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