Overview
Over the five days of this comprehensive and interactive virtual live training course, participants will develop a solid foundation in all the key regulatory requirements of European Clinical Pre- and Post-Marketing Safety. They will also be brought up-to-date on all the current news and developments in international pharmacovigilance harmonisation and standardisation activities.
- Day 1 - Module 1: Definitions and Methods in Pharmacovigilance
- Understand legal basis of requirements (GVP modules, ICH and Volume 10)
- Define criteria of a valid report. What to do in case of abuse, misuse, overdose or medication error?
- Differentiate between solicited and unsolicited reports
- How to report and follow up?
- Day 2 & 3 - Module 2: Regulatory Aspects in Pharmacovigilance and Practical Examples
- How to report adverse reactions in Clinical trials and post marketing
- Aggregate reporting
- The role and responsibilities of the QPPV
- Insights in audits and inspections and their preparation
- Day 4 - Module 3: Signal Detection and Management
- The principles of Signal Management – from industry and regulatory perspectives
- Medical evaluation of adverse drug reactions
- Which epidemiologic study design to choose
- Day 5 - Module 4: Risk Management
- Present and Future of Pharmacovigilance – PRAC perspective
- The components of Risk Management
- Effectiveness of Risk minimization
- How to communicate Risks?
You can also register for each of the four course modules individually.
What participants from the previous virtual course say:
"In general, the whole course Excellence in PV was very well planned (in terms of topics covered) and organized with very good selection of presenters. The interactive part of the sessions was not affected by the fact that this was an online course. Based on this experience, you can consider with continuing online courses even after the pandemic is over. I would certainly attend and recommend it to my colleagues."
Program Committee
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Wendy Huisman, PharmD Director
Vigifit, Netherlands -
Fakhredin Sayed Tabatabaei, MD, PhD Senior Assessor
MEB, Netherlands
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