The EU Clinical Trial Regulation + EU Filings & Registrations 2017

  • 1695.00 Dollar US$
  • Published date: September 21, 2017
    • Zurich, Switzerland, Hilton Zurich Airport, United States

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 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


Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901354SEMINAR?science-marketplace-November-2017-SEO

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel

Result 0 votes
John Robinson
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • Diversity and Inclusion 101

    Diversity and Inclusion 101

    Quality Control, Safety & Security Fremont, CA (California) March 20, 2019 110.00 Dollar US$

    Overview Diversity and inclusion are common buzzwords these days but few understand what they really mean or entail. In this webinar, we will explore what diversity and inclusion REALLY are as well as common myths and misconceptions. We will discuss ...

  • Oxaloacetate Assay Kit II

    Oxaloacetate Assay Kit II

    Quality Control, Safety & Security Shirley (New York) February 26, 2019 10.00 Dollar US$

    Oxaloacetate (OAA, HOOC-CO-CH2-COOH) is a TCA cycle intermediate. It precedes citrate which is formed by the transfer of an acetyl group to OAA. OAA is formed by the deamidation of aspartate or condensation of CO2 with pyruvate or PEP. Since mammals ...

  • Controlled Document System for a Life Sciences Manufacturing Plant

    Controlled Document System for a Life Sciences Manufacturing Plant

    Quality Control, Safety & Security Fremont (California) February 22, 2019 150.00 Dollar US$

    Overview: Life science manufacturing plants have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions...