Intended Learning Outcomes:

Knowledge and Understanding

Successful students will typically...

• Develop a systematic understanding of, and a critical awareness of, the  practical aspects of nonclinical development, types and design of nonclinical safety studies and pharmacokinetic requirements in the context of the nonclinical research phase of drug development
• Demonstrate a comprehensive understanding of the nonclinical regulatory requirements, nonclinical guidelines and other requirements for running nonclinical drug safety studies
• Have a conceptual understanding of the legal and ethical aspects of nonclinical research and the importance of critical evaluation of the study designs and data generated during research on medicinal products.

Skills and Attributes

Successful students will typically...

• Demonstrate the ability to critically analyse the nonclinical regulatory documentation and guidelines for the nonclinical part of drug development
• 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 communications from regulatory bodies and research publications covering the nonclinical data.

CPD

This course offers 15 CPD hours for successful completion, to learn about why CPD is important visit the Lifelong Learning page

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.

• Students completing MSc Regulatory Affairs: £1500.00 plus VAT £300.00 20% Total £1800.00
• Non Student: £1700.00 plus VAT 20% £340.00 Total £2040.00

   

  
  

All fees are shown in Pounds Sterling and include VAT (where applicable) Terms and conditions apply.