Essentials of European Pharmaceutical Regulatory Affairs

Essentials of European Pharmaceutical Regulatory Affairs
Regulatory Affairs can be confusing and complex, particularly if you have no formal industry background. This course provides an awareness of the regulatory environment.

When: 22 November 2018
Where: TOPRA, 6th Fl, 3 Harbour Exchange, South Quay, London, E14 9GE, UK  

Time: 9:30-16:00
 
 

What is it?
Regulatory Affairs can be a confusing and complex place, particularly if you have no formal industry background. This course will provide a basic grounding of the regulatory affairs profession in a relaxed, enjoyable environment.

Who is it for?
This is course is designed for those who are new to regulatory affairs and require an overview of the profession. In particular those from related disciplines (eg manufacturing, marketing and sales, support staff, etc.) and those wishing to move into the profession.


What will I learn?
This course will cover: 
  • Background to regulatory affairs
  • The European legislative framework
  • Overview of drug development
  • Overview of clinical trials
  • Marketing Authorisation Applications
  • Labels and leaflets
  • European Procedures
  • Lifecycle management, including variations
CPD: 6

Programme

Click here to download the course programme
 

How do I apply? 
This course is now full. To be added to the waiting list, please email meetings@topra.org.

 The next Essentials of European Pharmaceutical Regulatory Affairs course will take place on 28 March 2019 - Book now to avoid disappointment.

Course fees:
Type Registration fee
Standard    £580+VAT

Discounted places
A limited number of discounted places are available at the rates below. Please email us at meetings@topra.org for a discount code before making your booking.
Those working for regulatory agencies, government agencies or academic institutions 
  £435+VAT
  
Those working for charities, patient groups or are in full-time education
  £290+VAT

 

Terms and conditions 
By booking a place on this course you are agreeing to the training terms and conditions.
When
22/11/2018 09:30 - 16:00
Where
TOPRA Office 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
Online registration not available.
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NOTE
Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

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