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33842 Conferences

The EU Clinical Trial Regulation + EU Filings & Registrations 2017

Added by globalcompliancepanel on 2017-09-06

Conference Dates:

Start Date Start Date: 2017-11-02
Last Date Last Day: 2017-11-03
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2017-11-01

Conference Contact Info:

Contact Person Contact Person: Event Manager
Email Email:
Address Address: Zurich, Zurich, 89119, Switzerland
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

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.


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 interact
Which registration procedure to use
How regulations effect product development strategies
Pricing issues - Coordinated filing vs. Individual filing
Understanding the concerns/issues of European Regulatory Personnel
How to negotiate with the regulators
Information necessary for effective submissions
Strategies for streamlining the registration application process for faster approval
The advantages and disadvantages of various registration procedures
How to efficiently initiate trials.....first patient, first visit
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 and EUCTR vs. FDA IND Regulations
Impending Changes of the EU Clinical Trial Regulation and timing for Implementation


Day 1 Schedule

EU Clinical Trial Directive / New EU CT Regulation

Lecture 1:
Overview of the EU and EU Regulatory Structure
Lecture 2:
Overview of the EU Clinical Trial Directive, the 2007 Pediatric Legislation
Lecture 3:
Impending Changes of the EU Clinical Trial Regulation
Lecture 4:
Clinical Trials in the EU
Phases of a clinical trial
Start-Up and Application Processes
Ethics Committee and Competent Authority Review Process
Trial Protocol and Management
GCP and GMP Compliance
Labeling Requirements
Lecture 5:
End of a Clinical Trial
Lecture 6:
How Changes of the new Clinical Trial Regulation will affect Sponsors

Day 2 Schedule

European Filing & Registration Procedures

Lecture 1:
EU Agency Regulatory Structure
Lecture 2:
Registration Options
Lecture 3:
Company Strategy- Linking Clinical Trials & Marketing Authorization Applications
Lecture 4:
Balancing Strategy and Long Term Regulatory Cost & Maintenance
Lecture 5:
Registration Procedures
Member State Procedures
Mutual Recognition Procedure
Centralized Procedure
Lecture 6:
Abridged Applications
Similar Products & Devices
Request for Extensions
Use of Expert Reports
Lecture 7:
Generics, Orphan Drugs, Biologics and Combination Products
Lecture 8:
Changes Concerning Manufacturing Aspects (Product & Process)
Labeling & Packaging Leaflet Requirements
EU Commission Regulations
Lecture 9:
Decision Making Process
Check-in Procedure
Internal Commission
Industry's Ability to Impact?- Involvement & Timing
Standing Committee Participation
Favorable Standing Committee Opinion
Non-Favorable Opinion ?- Process & Timing

Read More: trol/globalseminars/~product_id=901354SE MINAR?worldconferencecalendar-November-2 017-SEO
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