概要

This course is designed to provide a strong foundation in all important key aspects of European Clinical Pre- and Post-Marketing Safety regulatory requirements. This comprehensive and interactive five-day training course also includes highlights and updates on the pharmacovigilance legislation and the latest news on the international harmonisation and standardisation activities in pharmacovigilance.

It is also possible to register to each of the 4 course modules individually:
Module 1: Definitions and Methods in Pharmacovigilance
Module 2: Regulatory Aspects in Pharmacovigilance and Practical Examples
Module 3: Signal Detection and Management
Module 4: Risk Management

98% of past course participants would recommend this course to a colleague or a friend

"I would like to praise Jan Petracek and Gaby Danan for their knowledge and enthusiasm transformed in presentation."
Maja Vovk, PV coordinator, Medis d.o.o., Slovenia

"Very good course, a lot of materials with explanations and examples, the faculty members were excellent, the organisation was brilliant and the venue was very appropriate. Great! Thank you!"
Iliyana Mitova, Pharmacovigilance Assistant, Pharma Support Services Ltd., Bulgaria

"I really liked the presentation skills of Jan Petracek, even though I was less familiar with the topics presented by him, they were presented in a very clear, transparent manner. I did not get bored during the presentation and found the topics very interesting."

"Very good presentation skills of the knowledgeable experts."

何を学ぶか

Definitions and Methods in Pharmacovigilance
Regulatory Aspects in Pharmacovigilance and Practical Examples
Diagnosis of Adverse Drug Reactions
Signal Detection and Signal Management

Modern Technologies and Social Media

Risk Management

参加対象

This course will benefit professionals with basic knowledge and experience in Pharmacovigilance or adjacent functions, for example, PV Officers, PV Specialists, PV Experts, PV Coordinators, Heads/Directors/Managers of Regulatory Compliance, Quality or Safety departments.
Level: Beginner/Intermediate

学習目的

Additionally to the five key topics, you should also be able to:

Understand basic definitions and methods in pharmacovigilance
Describe the expedited and periodic ICSRs reporting requirements in clinical trials and post-marketing including the medical evaluation
Understand the process of audits and inspections in pharmacovigilance
Understand the principles of signal management
Describe the components of the risk management

プログラム委員会

Gaby L. Danan, MD, PHD Pharmacovigilance Expert
GLD, France
Fakhredin Sayed Tabatabaei, MD, PHD Senior Assessor
MEB, Netherlands

Digital Learning Catalog

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Joint MEB/DIA Excellence in Pharmacovigilance: Clinical Trials and Post-Marketing training course

概要