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PRESS RELEASE from provider: Business Wire
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: EU Pharmaceutical Regulations & Strategy (London, United Kingdom - April 29-30, 2019) - ResearchAndMarkets.com

February 22, 2019

DUBLIN--(BUSINESS WIRE)--Feb 22, 2019--The “EU Pharmaceutical Regulations & Strategy” conference has been added to ResearchAndMarkets.com’s offering.

This course will provide an up-to date overview of the European pharmaceutical regulatory environment, procedures and obligations.

You will learn about the legal basis of regulation, development strategies and the strategic importance of pre-submission actions, the format for presentation of data, how the registration procedures work and post-authorisation strategies and obligations.

It will be of value for regulatory affairs personnel and also for those who interact with regulatory personnel in order to understand action timelines and information requirements.

Benefits of Attending

This course is for you, particularly if involved in:

Agenda

Programme Day One

EU regulatory environment: legal basis

Development strategy and pre-submission activities

Case study 1: Submission requirements

The Common Technical Document (CTD)

Case study 2: Registration strategy discussion

Will Brexit alter this?

Programme Day Two

Registration procedures

Managing product labelling

Abridged applications

Post-authorisation obligations and strategic considerations

Safety reporting

Licence variations

Type I and Type II variations

Strategic considerations

Case study 3: Post-authorisation strategy discussion

Will Brexit alter this?

Licence renewals

For more information about this conference visit https://www.researchandmarkets.com/research/hpn79p/2day_course_eu?w=4

View source version on businesswire.com:https://www.businesswire.com/news/home/20190222005307/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:Drug Discovery

KEYWORD: UNITED KINGDOM EUROPE

INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL

SOURCE: Research and Markets

Copyright Business Wire 2019.

PUB: 02/22/2019 09:47 AM/DISC: 02/22/2019 09:47 AM

http://www.businesswire.com/news/home/20190222005307/en