GCP Announces Webinar on European Union Filings and Registrations
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Website http://bit.ly/1kpO4Ui |
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Category Webinar, Health, Medical, Pharma, Clinical, Food / Drugs
Deadline: April 25, 2014 | Date: April 25, 2014
Venue/Country: USA, U.S.A
Updated: 2014-03-11 15:33:02 (GMT+9)
Call For Papers - CFP
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. Areas Covered in the Session:How the EU and individual countries within Europe interactWhich registration procedure to useHow regulations effect product development strategiesCoordinated filing vs. Individual filingUnderstanding the concerns/issues of European Regulatory PersonnelHow to negotiate with the regulatorsInformation necessary for effective submissionsStrategies for streamlining the registration application process for faster approvalThe advantages and disadvantages of various registration proceduresHow to link the strategy of Country selection to an ultimate EU Licensing PlanAgendaEU Agency Regulatory StructureRegistration OptionsCompany Strategy- Linking Clinical Trials & Marketing Authorization ApplicationsBalancing Strategy and Regulatory Cost/Maintenance2007 Pediatric Legislation OverviewIMP Dossier- EU Expectations and Comparison of CTA to IND ApplicationsRegistration ProceduresMutual Recognition vs. Centralized ProcedureAbridged ApplicationsVariationsLabeling & Packaging Leaflet RequirementsChanges to Marketed ProductsMaintaining Your License: RenewalsDecision Making ProcessReview of Regulatory AuthoritiesInternational, Regional, and Local laws applicable for the European UnionMember State Analysis of Applicable RegulationsPolitical Implications of the RegulationsCompare/Contrast EMEA and the FDA proceduresHow and When to Influence the Regulatory ProcessUsing Regulations / Regulatory Contacts to Your AdvantageWho Will Benefit:EU RegulatoryAdministrative StaffSales or General ManagementComplianceClinical Research OrganizationsFor 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. Quick Contact:GlobalCompliancePanel USA Phone:800-447-9407webinarsglobalcompliancepanel.comhttp://www.globalcompliancepanel.comEvent Link - http://bit.ly/1kpO4Ui
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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