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.
The Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom has accredited this training course with 32 CPD credits.
The Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM) have accredited this training course with 32 credits.
DIA is an authorised training organisation accredited under the number 11 99 53383 75 to the Préfet of Ile-de-France.
What participants from previous course say:
"I found the course very enjoyable, I learned a lot and it also reinforced the knowledge I already had. The course was very thorough."
"Comprehensive overview of diverse PV topics with practical examples during a relatively short time period."
"Based on my experience I will reccomend this course to my colleagues and any one else within the industry and I am looking forward to continue to participate in DIA courses."
"This event provided a comprehensive overview of Pharmacovigilance reinforcing the linkages across the system (data collection, signal detection, risk management etc). A focused and direct way to get a broad appreciation of PV regulation as it applies today."
What you will learn
Definitions and Methods in Pharmacovigilance
Regulatory Aspects in Pharmacovigilance and Practial Examples
Diagnosis of Adverse Drug Reactions
Signal Detection and Signal Management
Modern Technologies and Social Media
Who should attend?
Professionals involved in pharmacovigilance and namely Qualified Persons for Pharmacovigilance (EU QPPV), clinical research, regulatory affairs, risk management, medical product safety assessment, data analysis, epidemiology, labelling, quality assurance, compliance, and medical information.
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
Describe how to be prepared for 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
GLD Conseil, France
Phil Tregunno • Signal Management & Quality Standards Unit Manager
MHRA, United Kingdom