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.
RAPS Approved Webinar on Pharmaceutical Filings & Registration Procedures in the EU Date & Time: Course "Pharmaceutical Filings & Registration Procedures in the EU" has been pre-approved by RAPS as eligible for up to 1.5 Register Now credits towards a participant's RAC recertification upon full completion. Instructor Profile: Wednesday, August 22, 2012 10:00 AM PDT | 01:00 PM EDT Robert J. Russell Duration: 90 Minutes Instructor: Robert J. Russell President, RJR Consulting, Inc. Location: Online Price : $295.00 (for one participant) For the past 9 years, Bob has been President of RJR Consulting, Inc. The Overview: company assists the pharmaceutical, This session covers the various licensing methods (for Drugs, medical device and biotech Biologics & Combination Products) by which applicants can file for industries in understanding and product licenses (Marketing Authorizations) in one or multiple complying with International Regulations affecting compliance, Member States, as well as fully across all Member States of the new product development, European Union. manufacturing and quality assurance. RJR has offices in This course specifically outlines and discusses the structure of the Columbus, OH, Washington, DC, regulatory agencies at the EU-level and across specific Member Brussels, Belgium with exclusive States. Course content will explain which procedures are available affiliates across Asia and Latin for which products and then will follow the license processing steps America. Bob has 28 years of past for each pathway. industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Product examples will be discussed to illustrate effective filing Merion Merrill Dow pharmaceuticals techniques and when Full vs. Abridged applications will be required. and Cordis-Dow medical devices. He The Course will link the requirements of the EU Clinical Trial Directive has a BS / MS degree in Chemistry. and discuss when existing clinical data might be sufficient to file. ...more 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 Suggest a Topic More Webinars will explain how the EU interacts with national regulatory agencies and how companies can best address the conflicts that sometimes Your Necessity is our Priority arise. Areas Covered in the Session: l EU Agency Regulatory Structure l Registration Options l Company Strategy- Linking Clinical Trials & Marketing Authorization Applications l Balancing Strategy and Regulatory Cost/Maintenance l 2007 Pediatric Legislation Overview l IMP Dossier- EU Expectations and Comparison of CTA to IND Applications l Registration Procedures ¡ Mutual Recognition vs. Centralized Procedure l Abridged Applications l Variations ¡ Labeling & Packaging Leaflet Requirements l Changes to Marketed Products l Maintaining Your License: Renewals l Decision Making Process l Review of Regulatory Authorities ¡ International, Regional, and Local laws applicable for the European Union l Member State Analysis of Applicable Regulations l Political Implications of the Regulations ¡ Compare/Contrast EMEA and the FDA procedures l How and When to Influence the Regulatory Process l Using Regulations / Regulatory Contacts to Your Advantage Click here to register for this webinar Who Will Benefit: l Regulatory personnel l Administrative staff l Compliance Professionals l Sales or general management l Clinical Research Professionals It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. 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