An effective and efficient pharmacovigilance system is essential to protect the wellbeing of patients, to meet regulatory requirements and to protect the commercial interests of organizations which market medicinal products or sponsor clinical trials.
The aim of this course is to facilitate the delegates contribution to improving the efficiency and effectiveness of the pharmacovigilance system. It will promote a clear understanding of the regulatory requirements and explore best practice in discharging legal and commercial responsibilities for marketing medicinal products for human use.
Introductions, overview of the course. What do we need to know to succeed? Pharmacovigilance planning.
The Regulatory Framework
Assessing and Processing Adverse Events
Collection, collation and evaluation of individual case safety reports. Quality management of the process.
Data Management in Pharmacovigilance
Using IT to support the PV process
Practical exploration of event assessment, processing, follow-up and documentation.
Pharmacovigilance and the Interventional Clinical Trial
Information flow and the responsibilities of the sponsor
Roles and Responsibilities of the Qualified Person for
What is a signal? Regulatory requirements.
How is signal detection and evaluation conducted? Qualitative and quantitative methods of signal detection.
Upon completion of this course, participants should be able to:
Appreciate the wide scope of company responsibilities
Develop confidence in handling quality issues within the pharmacovigilance system
Discuss and develop ideas
Solve specific problems
Who Should Attend
Professionals working in the area of:
Qualified Persons responsible for Pharmacovigilance
Regulatory Affairs Professionals
Certificate of Attendance and Course Material
All participants will receive a certificate of attendance upon completion of the course.
The participants will be receiving specially prepared course manual.