The US Regulatory Environment

The US Regulatory Environment
Module 11 of the MSc (Medicines) and Masterclass: The purpose of this module is to provide you with an understanding of the regulatory environment in the USA in order to place these global influences in perspective. As the largest single country market for pharmaceutical products, the regulatory requirements of the US FDA has a major influence on the design of pharmaceutical development programmes both within the USA and globally. This module offers an understanding of the US regulatory environment in order to place these global influences in perspective.

When: 11 April - 13 April 2018
Where: De Vere Latimer Estate, Chesham, UK


What is it?

  • Outline of Module Topics:

    • History of drug regulation in the USA
    • The basis of Regulatory Affairs in the USA
    • FDAMA and PDUFA VI and all UFAs
    • The IND process and how to manage it
    • The ANDA
    • The SNDA and manufacturing strategies: SUPAC and BACPAC
    • OTC products
    • Orphan drugs
    • Fast track approvals
    • Adverse event reporting
    • Labelling, advertising and advertising controls
    • Communication with the FDA
    • Making maximum use of the NDA

    Learning outcomes:
    You will understand the legal basis of pharmaceutical regulations in the USA and how the FDA operates within the legal framework.

     

     

 


Who is it for?
This course is suitable for anyone working in US , or individuals involved in this area and students completing their MSc in regulatory affairs (Medicines) or (Medical Devices). This will be a valuable course to ensure you are up to date with the current US legislation and guidelines.

 

 

What will I learn?
Download the full programme

CPD: 18.5


How do I apply? 

Course fees:
Type Student Non-Student
Standard    £1500+VAT £1700+VAT 

Discounted places
A limited number of discounted places are available for those working in regulatory agencies, government bodies, charities or patient groups . Please email us for a discount code before making your booking.


 

Terms and conditions 
Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions 


     

    Travel and accommodation is not included. You will receive information on how to book accommodation and special rates once you have booked onto the course. The special bed and breakfast rate is £99.00 plus VAT per night.


    The discounted rate is limited to six weeks prior to the start of the module and may change subject to availability, so please ensure you book as soon as possible.


     
    When
    11/04/2018 - 13/04/2018
    Where
    De Vere Latimer Estate Chesham HP5 1UG UNITED KINGDOM
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