This course is designed to provide trainees with knowledge, skills and attitudes of efficient regulatory pharmaceutical affairs and Pharmacovigilance specialists.
On Regulatory Affairs
Pharmaceutical Sector in Kenya is very broad and wide and therefore research and training. Jeyflex Consultants understands that, what its potential current client’s need is training of new staff members for its clients especially during this time when the medical sector is on the spot light dealing with diseases like Cancer and COVID 19 virus pandemic to which they are committed.
Professional training in regulatory affairs and pharmacovigilance course overview
MODULE 1: Regulatory Affairs Training
- Registration of medical products and health technologies. These include Human and veterinary pharmaceutical products , medical devices & invitro diagnostics, herbal products , borderline products.
- Ectd dossier compilation, audit and submissions .
- Post registration regulatory processes such as variations , renewals , marketing and product promotion.
- People skills such as emotional intelligence and customer experience .
Course duration: 80 hours – spread according to clients availability and schedule.
MODULE 2: Pharmacovigilance Training
- Introduction to Pharmacovigilance
- Principles of good pharmacovigilance practices
- Pharmacovigilance system master file
- Risk management plands
- Periodic safety reports
- Pharmacovigilance data
- Sources of safety information
- How to collect, record, evaluate and report safety information
- Requirements and Responsibilities of the qualified person for pharmacovigilance (QPPV)
Course duration: 60 hours – spread according to clients availability and schedule.
Why work with us?
Customer service shouldn’t just be a department, it should be the entire company.
Interested In Our Training Services?
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