Basic Regulatory Aspects of Clinical Development

Get a basic overview of clinical development

  • TBD

2 days course

English

3.500,- DKK ex VAT
(app. 471,- EUR ex VAT)

At the moment there is no available dates for this course.

Summary

This course will give you a basic overview of clinical development. You will learn the clinical requirements for a regulatory application for a new treatment, a new product or a new indication. You will also learn what Good Clinical Practice (GCP) is and how trials are designed to meet the regulatory requirements.

The course is relevant for you if you are a regulatory affairs professional with limited knowledge about clinical development or a professional who provides documents to regulatory affairs that are to be used for applications to health agencies.
  

Keywords

Clinical development phase I, II and III
Good Clinical Practice (GCP)
Design and end points
Randomized clinical trial
Dose-response and dose-selection  
Comparators and target population
Biostatistics in clinical development, ICH E9
Regulatory risk assessment
Benefit-risks
Product summaries

What you will learn

  1. The basic principles of clinical development and requirements for marketing authorization
  2. The impact of regulatory requirements for clinical documentation
  3. How to evaluate the basic needs for clinical data to support a regulatory application to health agencies

What your company will get

  1. A regulatory affairs professional who has a basic understanding of the main issues in clinical development
  2. A regulatory affairs professional who can give valuable input on regulatory affairs issues related to clinical development
  3. A regulatory affairs professional who will be better qualified to attend the Atrium course on Clinical development and documentation

Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call Carina Schaldemose Hansen, Digital Project Manager at + 45 39 15 09 22, or send her an email at csc@atriumcph.com.

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick on the day of the course, you can hand over your seat to a colleague. To hand over your seat, please contact us at +45 39 27 60 60. Read our cancellation policy.

Want to know more about this course?

Contact Senior Programme Director Tina Jensen at +45 39 15 09 14

Send an email

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