Preclinical and Clinical Aspects of Pharmacovigilance

Learn about preclinical safety studies and safety monitoring in clinical phase I, II and III studies

  • 25. Jan 2018

2 days course

English

11.200,- DKK ex VAT
(app. 1.506,- EUR ex VAT)

Module 5  

Summary

This course will help you understand the preclinical and clinical aspects of pharmacovigilance, including preclinical safety studies. You will also learn about decisions for safety margins and first-dose-in-man, safety principles in phase I, II and III studies, and regulations for safety assessments.

After the course, you will be able to analyze the different pre-application tasks related to preparing clinical study protocols, annual safety reports (SUSARs), integrated clinical study reports and scientific advice in relation to the preparation of clinical trial applications (e.g. endpoints, statistical power, safety parameters, etc.) as well as the pre-application tasks related to conducting clinical studies.

The course is offered every 2 years.

Keywords

Pre-clinical Safety Studies
Drug Development
Clinical Safety Studies
Risk Assessment
Pharmacovigilance in Clinical Trials
Drug Safety
Regulatory Affairs
Communication with Regulatory Authorities

What you will learn

 

  1. Why preclinical safety studies are done and what preclinical data can be used for in safety assessments
  2. The rationale behind dose selection for first-dose-in-man trials and the reasoning behind decisions for safety margins
  3. The principles of safety monitoring in clinical phase I, II and III studies and regulations for the assessment and monitoring of safety issues in clinical studies
  4. How pharmacovigilance units can co-operate with regulatory authorities
  5. How to share knowledge on preclinical and clinical aspects of pharmacovigilance

What your company will get

  1. A safety and pharmacovigilance professional who understands why preclinical safety studies are done and what preclinical data can be used for in safety assessments
  2. A safety and pharmacovigilance professional who understands the relationship between pharmacovigilance and the processes of application and registration
  3. A safety and pharmacovigilance professional that can independently analyze and evaluate the steps in regulating drug safety
  4. A safety and pharmacovigilance professional who can provide valuable input to all other team members working with preclinical and clinical aspects of pharmacovigilance
Available start dates

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 Programme Director Gitte Hornemann Møller at +45 39 15 09 20

Send an email

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