Joint MHRA/DIA Excellence in Pharmacovigilance: Clinical Trials and Post-Marketing
This course is designed to provide a firm grounding in key aspects of European Clinical Pre- and Post-Marketing Safety regulatory requirements. This 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 for each of the 4 course modules separately:
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 2017 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."
What you will learn
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
Who should attend?
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.
For the five key topics as outlined above, the learning objectives also include the ability to:
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
Gaby L. Danan, MD, PhD • Pharmacovigilance Expert
Phil Tregunno • Group Manager, Vigilance, Intelligence and Research Group
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom