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This content is a press release from our partner Business Wire. The AP newsroom and editorial departments were not involved in its creation.

2-Day Course: The New Clinical Trial Regulation - Overview & Impact (London, United Kingdom - April 11-12, 2019) - ResearchAndMarkets.com

February 22, 2019

DUBLIN--(BUSINESS WIRE)--Feb 22, 2019--The “The New Clinical Trial Regulation: Overview and Impact” conference has been added to ResearchAndMarkets.com’s offering.

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU.

Why You Should Attend

The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC). The new regulation was originally due to come into effect in 2016, however implementation has been delayed until the new portal and clinical trial database have been completed and audited.

Key aims of the new regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new clinical trial database and portal. Guidelines for enacting the new regulation are also being prepared in a number of areas including inspection, investigational medicinal product and trial documentation etc.

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU. The course will highlight the most important of these key requirements and changes and how these are likely to impact on trials now and in the future for biopharmaceutical companies, CROs and study sites.

Key Topics Covered

Who Should Attend?

This course is ideal for anyone requiring an update on the new Clinical Trial Regulation. The course is relevant for those working in regulatory, clinical research, clinical operations, project management, pharmacovigilance, quality assurance (GCP auditors), vendor/CRO professionals, study sites and other professionals in pharmaceutical and biotechnology organisations conducting trials with drugs, biologics or combination products.

It will also be of interest to those departments who liaise/support clinical trial personnel, and all other professionals who want to know more about this important new Regulation.

Agenda

Introduction and Objectives

Background to the EU clinical research regulation in Europe

Changes in the new EU Clinical Trial Regulation

Clinical trial regulatory authorisation and ethical approval

Clinical trial transparency requirements in the EU

Investigational medicinal product/auxiliary product guidelines

Pharmacovigilance and adverse event reporting - key safety changes

Considerations for regulatory inspection - review of the delegated act

Summary and close

For more information about this conference visit https://www.researchandmarkets.com/research/2h6jt2/2day_course_the?w=4

View source version on businesswire.com:https://www.businesswire.com/news/home/20190222005339/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T. Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Related Topics:Clinical Trials,Medical Law

KEYWORD: UNITED KINGDOM EUROPE

INDUSTRY KEYWORD: EDUCATION HEALTH CLINICAL TRIALS TRAINING

SOURCE: Research and Markets

Copyright Business Wire 2019.

PUB: 02/22/2019 10:46 AM/DISC: 02/22/2019 10:46 AM

http://www.businesswire.com/news/home/20190222005339/en