The EU Clinical Trial Regulation + EU Filings & Registrations 2017
- Start Date:
- Thursday, 2 November, 2017
- End Date:
- Friday, 3 November, 2017 6:00pm
- Radiology, Physical Medicine, Headache / Migraine, Health & Nutrition, General Surgery, Plastic Surgery
Course "The EU Clinical Trial Regulation + EU Filings & Registrations" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive and the impending changes coming to the EU through the EU Clinical Trial Regulation (for Drugs, Biologics & Combination Products).
The course also covers recent updates on EU-GCP associated with the new regulatory framework, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. Additionally, the seminar will cover the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing].This course 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 [and EEA], 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. Learning Objectives / Key Topics: Attendees will leave the Course clearly understanding the requirements under the current Directive.
In addition, this Course has been updated to provide participants with competitive insight into:How the EU and individual countries within Europe interactWhich registration procedure to useHow regulations effect product development strategiesPricing issues - Coordinated 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 efficiently initiate trials.....first patient, first visitHow to link the strategy of Country Selection to an ultimate EU Licensing PlanEfficiently implementing studies via project teams and CROs at the National and multi-state levelHow to stay compliant.....What can make the difference in your data passing Regulatory scrutinyRelated area-GCP and PV-reporting updatesEUCTD and EUCTR vs.
FDA IND RegulationsImpending Changes of the EU Clinical Trial Regulation and timing for Implementation Agenda: Day 1 Schedule EU Clinical Trial Directive / New EU CT Regulation Lecture 1:Overview of the EU and EU Regulatory StructureLecture 2:Overview of the EU Clinical Trial Directive, the 2007 Pediatric LegislationLecture 3:Impending Changes of the EU Clinical Trial RegulationLecture 4:Clinical Trials in the EUPhases of a clinical trialStart-Up and Application ProcessesEthics Committee and Competent Authority Review ProcessTrial Protocol and ManagementGCP and GMP ComplianceLabeling RequirementsFeesLecture 5:End of a Clinical TrialLecture 6:How Changes of the new Clinical Trial Regulation will affect Sponsors Day 2 Schedule European Filing & Registration Procedures Lecture 1:EU Agency Regulatory StructureLecture 2:Registration OptionsLecture 3:Company Strategy- Linking Clinical Trials & Marketing Authorization ApplicationsLecture 4:Balancing Strategy and Long Term Regulatory Cost & MaintenanceLecture 5:Registration ProceduresMember State ProceduresMutual Recognition ProcedureCentralized ProcedureLecture 6:Abridged ApplicationsSimilar Products & DevicesRequest for ExtensionsUse of Expert ReportsLecture 7:Generics, Orphan Drugs, Biologics and Combination ProductsLecture 8:VariationsChanges Concerning Manufacturing Aspects (Product & Process)Labeling & Packaging Leaflet RequirementsEU Commission RegulationsLecture 9:Decision Making ProcessScopeCheck-in ProcedureInternal CommissionConsultationIndustry's Ability to Impact?- Involvement & TimingStanding Committee ParticipationFavorable Standing Committee OpinionNon-Favorable Opinion ?- Process & TimingLecture 10:Review of Regulatory AuthoritiesInternational, Regional, and Local laws applicable for each European Union NationLecture 11:Member State Analysis of Applicable Regulations At All Levels With Practical Examples of How the Regulations Are AppliedLegislative ProcessObjectives of the Rules Governing Medicinal ProceduresRegulatory FrameworkNew Products, Requirements, & ProceduresLecture 12:Political Implications of The RegulationsCompare/Contrast EMA and the FDA proceduresLecture 13:How and When to Influence the Regulatory ProcessEffective Monitoring ActivityAssociation vs.
Individual Company Involvement & InterventionThe Regulatory Negotiation ProcessEffective ApproachesThe Do's and Don'ts of Regulatory InvolvementLecture 14:How to Use Regulations / Regulatory Contacts to Your AdvantageCheck-in ProcedureInternal Commission InteractionsProcedures within each regulatory office, contacts, etc.Product Development StrategyBusiness Impact Within and Outside the EUProfessionalism in Regulatory LobbyingLecture 15:Maintaining Your License: RenewalsLecture 16:Helpful WebsitesLecture 17:Glossary of Terms SpeakerRobert RussellPresident, RJR Consulting, Inc.
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. Location: Zurich, Switzerland Date: November 2nd & 3rd, 2017 and Time: 9:00 AM to 6:00 PMVenue: Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50 Price: Price: $1,695.00 (Seminar Fee for One Delegate)Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)* Register now and save $200. (Early Bird)Until September 15, Early Bird Price: $1,695.00 From September 16 to October 31, Regular Price: $1,895.00Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)* Sponsorship Program benefits for "Quality Assurance Auditing for FDA Regulated Industry" seminarAt this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO's of various designations.
Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry. As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants. For More Information- https://www.globalcompliancepanel.com/control/sponsorship
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