An Essential Overview of Pharmacovigilance
Course
In The Rembrandt Hotel, London
Description
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Type
Practical seminar
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Level
Intermediate
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Location
The rembrandt hotel, london
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Class hours
8h
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Duration
1 Day
Pharmacovigilance has become one of the most demanding aspects to both understand and comply with. There are many requirements for companies to perform regarding the safety of their products to satisfy regulatory demands, and sanctions for non compliance can be severe. This course will provide a concise overview of the pharmacovigilance function and the regulatory requirements.
Facilities
Location
Start date
Start date
About this course
The new Pharmacovigilance Legislation requires companies to train all staff, including those not working directly with Pharmacovigilance and this course will meet that requirement.
TOPICS TO BE COVERED INCLUDE:-
An Introduction to EU Pharmcovigilance
Documentation to be supplied to Regulatory Authorities
Department links in the company to Pharmacovigilance
Licensing partners and Pharmacovigilance
The role of the Qualified Person for Pharmacovigilance
Standard Operating Procedures (SOPs) in Relation to Pharmacovigilance
This course will be relevant for anyone requiring an overview of Pharmacovigilance. It may be of particular interest to those new to Pharmacovigilance or in a support staff role. It will also be relevant to anyone who works with Pharmacovigilance – eg Regulatory Affairs, Clinical, Sales & Marketing, Legal, Commercial and Quality.
Reviews
Subjects
- Pharmacovigilance
- Qualified Person
- Pharam
- Pharma
- Pharmaceutical Regulations
- License holder
- Management
- Medical Devices
- Training
- SOP's
Teachers and trainers (1)
Graeme Ladds
Director, PharSafer
Course programme
09.00 Registration and Coffee
09.30 Meeting starts
An Introduction to EU Pharmacovigilance
- Safety reporting requirements
- Safety report sources
- Follow up of safety reports
- Electronic safety reporting
- Safety file retention
Documentation to be Supplied to Regulatory Authorities
- Individual Case Safety Reports
- Periodic Safety Update Reports (PBRERs; DSURs; RMPs)
- Answering queries from Regulatory Authorities
- Updating product labelling – emphasis on safety changes
Department Links in the Company to Pharmacovigilance
- Product Quality and Pharmacovigilance
- Sales and Marketing and Pharmacovigilance
- Legal, Commercial and Pharmacovigilance
- Regulatory and Pharmacovigilance
- Medical Information and Pharmacovigilance
The Roles and Responsibilities of a Licence Holder
- Obtaining a license for a product
- Supporting the license approval
- Submissions and license approvals
- Regulatory Inspections
The Role of the Qualified Person (QP) for Pharmacovigilance
- Contract versus Permanent
- Essential attributes of the QP
- The duties of the QP
- What the QP must do
- Internal audits of the Company Pharmacovigilance activities
Standard Operating Procedures (SOPs) in Relation to Pharmacovigilance
- Types of SOPs required
- Production and sign off of SOPs
- SOP maintenance
- SOP training
- Who should be trained and in what
Pharmacovigilance Inspections
- Preparation for a Regulatory Inspection
- Scope of the Pharmacovigilance Inspection
- Conduct of the Pharmacovigilance Inspection
- The Pharmacovigilance Inspection Report
- Corrective actions following a Pharmacovigilance Inspection
17.00 Meeting ends
Additional information
An Essential Overview of Pharmacovigilance