Regulatory Strategy for a New Active Substance: GCD

Regulatory Strategy for a New Active Substance: GCD
Module 4 of the MSc: This will enable you to develop effective regulatory leadership within your organisation throughout the clinical development and the registration of a new medicine.

When: 27-29 November 2017
Where: De Vere Latimer Estate, Chesham, UK

What is it? 

 This module will cover designing a CT program, the overview of  requirements and phases of clinical development. Toxicology package requirements for each phase of the development and the ethnic factors for Non-ICH markets, statistical input, paediatric and other specialist populations as well as unconventianal study designs and the philosophies and assessment techniques of the regulatory authorities.

This is the only face to face course that has speakers from the MHRA so you can interact with the regulatory authorities and gain their perspective on your submissions.

  • Knowledge and Understanding


    Successful students will typically.....

    • display a systematic understanding of knowledge, and a critical awareness of the regulations and international directives pertaining to clinical development of a new medicine
    • Show a critical awareness of the clinical programme strategies which can be employed during development and registration of a new medicine of clinical programme strategy, and effective regulatory leadership throughout the clinical development and the registration of a new medicine
    • Display a comprehensive understanding of the EU legislation on the different aspects of clinical development, and of the procedures and regulatory requirements for clinical trial reports clinical overview and summary documents for optimal product labelling
    • Evaluate methodologies and develop critiques of the medical, statistical, economic and operational aspects of clinical trial programmes.

    Skills and Attributes

    Successful students will typically...

    • Demonstrate the ability to critically analyse the legal documentation and global operational clinical trial programme considerations of clinical research
    • deal with complex issues both systematically and creatively, make sound judgements in the absence of complete data, and communicate their conclusions clearly to specialist and non-specialist audiences
    • Critically appraise and evaluate global clinical research communications from regulatory bodies and research publications.

 


Who is it for?
This course is suitable for anyone working in global clinical development, or individuals involved in this area, who are interested in non-clinical development, and students completing their MSc in regulatory affairs.

 

 

What will I learn?

To download the programme please click HERE

To learn about why CPD is important visit the Lifelong Learning page. 


CPD: 19

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
27/11/2017 - 29/11/2017
Where
De Vere Latimer Place Chesham HP5 1UG UNITED KINGDOM
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