Introduction to Clinical development of New Medicine

This course provides you with a general overview and understanding of why and how we do clinical drug development

  • TBD

2 days course

English

8.500,- DKK ex VAT
(app. 1.143,- EUR ex VAT)

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

SUMMARY

This course gives you a general overview and understanding of why clinical drug research is conducted the way it is today, how drugs are developed, how to monitor adverse drug reactions (ADRs), what monitoring during clinical trials entails and who is responsible for what during the entire process, from before the molecule has been discovered to the point where it is administered as a drug to patients.

Our course will combine teaching by experts, workshops and group work, meaning there will be plenty of opportunities for you to put your learning into practice and engage in discussions with your teachers and fellow students.
  

Keywords

Definition of Target Product Profile
Clinical Development Plans
Clinical Development Phases
Study Design and use of Clinical Data
Pharmacovigilance During Development and After Marketing
Data Monitoring During Clinical Trials
Good Clinical Practice (GCP)

What you will learn

  1. The basic principles of clinical drug development
  2. Study designs and different phases of drug development (Pre-clinical, Phase I, II & III studies, post-marketing studies)
  3. The importance of pharmacovigilance during study conduct and post-marketing
  4. The importance of data monitoring during clinical trials according to ICH Good Clinical Practice (GCP)
  5. The regulatory requirements in the drug development life cycle and market authorization process

What your company will get

  1. An employee who understands the basic principles of clinical drug development
  2. An employee who understands the importance of data monitoring and data safety (pharmacovigilance)
  3. An employee who understands the regulatory requirements during drug development and the market authorization process
  4. An employee who can provide valuable input to all other team members involved in clinical drug development

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 us at + 45 39 27 60 60, or send us an email at contact@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 and cannot attend the course, you may hand over the seat to a colleague, who will then have to register for the course on our website prior to course start. If the registration is closed, please send us full name, email, phone and title of your colleague to bfl@atriumcph.comRead our cancellation policy.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Programme Director Ann Jelert Kristensen at +45 39 15 09 52

Send an email

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