PharmiWeb.com - Global Pharma News & Resources
28-Jan-2019

2-Day Course: Regulatory Affairs for Support Staff (London, United Kingdom - September 23-24, 2019) - ResearchAndMarkets.com

The "Regulatory Affairs for Support Staff" conference has been added to ResearchAndMarkets.com's offering.

This course provides an introduction to Pharmaceutical Regulatory Affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

You will gain an overview of EU regulatory procedures required to register products in Europe and the regulatory activities that need to be complied with to keep products on the market.

Pharmacovigilance and safety reporting will be covered as well as license variations and the commercial aspects of Pharmaceutical products.

The course will provide a thorough grounding in the subject of Regulatory Affairs and enable you to perform in your role more effectively.

Agenda

Programme - Day one

European Law - Regulations, Directives

  • Impact of Brexit
  • Where can we find the information on regulatory affairs, approvals, withdrawal?*
  • The Internet/publications
  • Approvals and withdrawals

The drug development process

  • Drug discovery
  • Pharmaceutical R&D
  • Non-clinical tests
  • Clinical studies - Phase I to IV
  • Registration

CASE STUDY 1

  • The EU Clinical Trials Directive and Regulation*
  • What is the process for running clinical trials in Europe?

Seeking scientific advice in Europe

  • What are the processes?

The Common Technical Document

  • Structure and content of a CTD

The European Medicines Agency

  • Impact of Brexit

Impact of Brexit

Programme - Day two

Applying for a Marketing Authorisation in the EU with discussion on the impact of Brexit

  • The EU Centralised Procedure
  • Decentralised Procedure
  • Mutual Recognition Procedure
  • National procedures

CASE STUDY 2

Generic applications

  • Requirements

Parallel trade

  • How the process works
  • Impact of Bexit

Managing product labelling

  • Company core data sheets
  • Updates to Summary of Product Characteristics

Post Authorisation Obligations; Pharmacovigilance, variations and renewals including discussion on the impact of Brexit

Pharmacovigilance and GCP inspections

Licence variations

  • Type I and Type II variations
  • Procedures and timelines

CASE STUDY 3 Renewals

Managing and supporting a regulatory affairs department

  • Things to consider
  • Maintaining oversight

For more information about this conference visit https://www.researchandmarkets.com/research/xgw3z9/2day_course?w=4

View source version on businesswire.com: https://www.businesswire.com/news/home/20190128005288/en/

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Last Updated: 28-Jan-2019