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Regulatory Affairs For Support Staff (Course, London)

DUBLIN, Ireland, March 13, 2014 /PRNewswire/ --

Research and Markets ( has announced the addition of the "Regulatory Affairs For Support Staff (Course, London)" conference to their offering. 
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The Regulatory Affairs For Support Staff course will be held on the 20-21st March 2014 at The Rembrandt Hotel, London.

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

The first day will provide an overview of the EU Regulatory procedures, an insight into applying for clinical trials applications and seeking scientific advice and how to maintain product labelling whilst complying with pharmacovigilance requirements. You will gain an overview of the basics of the registration procedures and how to organise the registration files.

The second day will focus on the procedures required to register products in Europe and the Regulatory activities that need to be complied with to keep products on the markets. Pharmacovigilance and safety reporting will be covered as well as licence variations and the commercial aspects of pharmaceutical products.

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

Topics to be covered:

- Learn about the Drug Development Process - from Drug Discovery to Product Launch and Beyond

- Understand the Background of European Law - Regulations, Directives, etc.

- Discover where you can find Information on Regulatory Affairs, Approvals, Withdrawals, etc.

- What is the Centralised Procedure

- How to Seek Scientific Advice in Europe

- What is the Common Technical Document

- Applying for a Marketing Authorisation in the EU

- Key Aspects of Drug Safety Reporting

- Pharmacovigilance and GCP Inspections

- Managing Product Labelling

- Discussion on Licence Variations

- Understand Parallel Imports and Generic Applications


This course is specifically designed for anyone who is new to Regulatory Affairs, including personal assistants, secretaries, administrators and any member of support staff wishing to gain a greater understanding of Regulatory Affairs in the Pharmaceutical Industry. It is also suitable for those who interface with the Regulatory Affairs function and who provide support to the Regulatory procedures and activities.

Key Topics Covered: 

*Day One - 20 March 2014

Introduction to the Course,

Course Leader and Attendees

The Drug Development Process from Discovery to Product Approval

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

European Law - Regulations,Directives, etc.

Where Can We Find the Information on Regulatory Affairs, Approvals,Withdrawals, etc?

- The Internet
- Publications
- Regulations, Directives and Guidelines
- Approvals and withdrawals

The EU Centralised Procedure

- How it works
- Who is involved

The EU Clinical Trials Directive

- What is the Process for running Clinical Trials in Europe?

Seeking Scientific Advice in Europe

- What are the processes?
- How are the rocedures organised?

The Common Technical Document

- Structure and content of a CTD

End of Day 1

*Day Two - 21 March 2014

Applying for a Marketing Authorisation in the EU

- Mutual Recognition Procedure
- Decentralised Procedure
- National Procedures

Safety Reporting 

- Notice to Applicants requirements

Pharmacovigilance and GCP Inspections

- What to expect

Managing Product Labelling

- Company core data sheets
- Updates to Summary of Product 

Licence Variations

- Type I and Type II variations
- Procedures and timelines

Parallel Imports

- How the process works

Generic Applications

- Requirements

Managing/Supporting a Regulatory Affairs Department

- Things to consider
- Maintaining oversight

Close of Meeting 


For more information visit

Media Contact: Laura Wood , +353-1-481-1716, [email protected]

SOURCE Research and Markets

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