Drug Safety in Clinical Research

Your Speaker: Dr. Marcus Berger

Dr. Marcus Berger is a patient-centered scientist with a degree in biology (PhD 2006 - focus: pharmacology; biochemistry; physiology at the University of Cologne). After his academic career, he switched to the pharmaceutical industry, where he has been professionally active for over 16 years. During this time, he has undergone further training in clinical monitoring/clinical research, pharmacovigilance and pharmaceutical quality management. He has been self-employed as a GXP expert since 2014 and supports his clients in the areas of project management in clinical trials, GxP quality management and pharmacovigilance. He has successfully completed several projects for medium-sized companies in these areas. These include projects on Phase III trials from the perspective of a project manager and pharmacovigilance officer. He has been active as a trainer for almost ten years with a focus on pharmacovigilance in clinical trials and quality management.

More under:

www.gxpexpert.de

LinkedIn: Dr. Marcus Berger – GXP Expert

Target group: Project Managers; CRA; Medical Advisors; Clinical Operations; Regulatory Affairs Manager; Investigators, Pharmacovigilance Managers; QPPV

Participation fee: EUR 940.00 plus VAT

You will receive the training materials as a pdf document. You will receive a certificate of attendance after successfully completing the course.

Duration: Online training (MS Teams)

9 am until 5 pm (CET)

Date: 26-Mar-2025

Please use our registration form to register.
Registration deadline: 12-Mar-2025      

Training contents

Drug Safety in Clinical Research

• Pharmacovigilance in a Drug's Life Cycle
  • Pharmacovigilance in the Clinical Development
    • Overview Preclinical Stage
    • International Council for Harmonisation (ICH) Guidelines for Pharmacovigilance
    • Overview Clinical Development (Monitoring; AE-Reporting; DSMB; Patient-related-Outcome; Challenges and Benefit-Risk-Assessment)
  • Patient-Centric Pharmacovigilance and challenges
  • Real-World Evidence Integration and potential Artificial Intelligence and Machine Learning (Defining, Benefits and Challenges; Case examples)
• QPPV and Clinical Operation
  • Interaction between GCP and GVP
  • The Difference: Pharmacovigilance in Clinical Trials
  • Basis of SAE-Management
  • Technologies in Data Collection and Analysis
  • Collaboration Between Pharmacovigilance and Clinical Trial Department
    • Why Is this Collaboration So Important?
  • Critical Role of a Pharmacovigilance Physician in Medical Assessment
  • Unblinding for Safety Reason
• Reporting Obligations in Clinical Trials
  • Urgent Safety Measures and Emergence Safety Issue
  • SUSARs and Co. (Sponsor / Investigator)
  • Communication strategy for Adverse Event Reporting
  • Role of ICH-E2B R3
  • EudraVigilance Database and XEVMPD
  • Serious Breaches (incl. Examples), DSUR and Auxillary Medicinal Products
• SAE-Management in Minimal-interventional Clinical Trials
  • How can I customize the SAE-Management - prerequisites for implementation
  • The importance of ICH-E19 and CTR 536/2014
  • Practical examples
• Development Safety Update Report (DSUR) and Risk Management Plan
  • DSUR cycle
  • Which chapters are important
  • Reference Safety Information and Investigator Brochure
  • Link to Risk Management Plan
  • Excursus Post-Authorization-Safety-Study (PASS)

The training can also be offered as in-house training.

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