Pharmacovigilance has undergone rapid regulatory change in recent years and become one of the most demanding aspects of the pharmaceutical industry to both understand and comply with. There are many requirements and duties for companies to perform regarding the safety of their products to satisfy regulatory demands, and sanctions for non-compliance can be severe.
EU pharmacovigilance legislation requires companies to train all staff, including those not working directly in pharmacovigilance, and this invaluable one-day course will help you meet that requirement with a concise overview of the pharmacovigilance function and current regulatory requirements.
Benefits of attending
- Gain an overview of EU pharmacovigilance
- Understand the documentation required by regulatory authorities
- Clarify the roles and responsibilities of a licence holder
- Understand the role of the Qualified Person for Pharmacovigilance (QPPV)
- Review the standard operating procedures (SOPs) in relation to pharmacovigilance
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Agenda
An introduction to EU pharmacovigilance
- Safety report sources
- Safety reporting requirements
- Follow-up of safety reports
- Electronic safety reporting
- Safety file retention
Documentation to be supplied to regulatory authorities
- Individual case safety reports - special situations - EU
- 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 licence for a product - the PSMF
- Supporting the licence approval
- Quality management requirements
- Submissions and licence approvals
- Regulatory inspections
The role of the QPPV
- Essential attributes of the QPPV
- The duties of the QPPV and what the QPPV must do
- Internal audits of the company's pharmacovigilance activities
SOPs in relation to pharmacovigilance
- Why the need for SOPs?
- Critical SOPs
- SOP maintenance
- SOP training
- Who should be trained and in what?
Pharmacovigilance inspections
- Purpose of a regulatory inspection
- Scope of the pharmacovigilance inspection
- Conduct of the pharmacovigilance inspection
- The pharmacovigilance inspection report
- Corrective actions following a pharmacovigilance inspection
Speakers
Mr Graeme Ladds,
Director ,
PharSafer Associates Ltd.Graeme Ladds, Director of PharSafer, has over 22 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.
The last 11 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.
Who Should Attend
This course will be relevant for anyone requiring an overview of pharmacovigilance or wishing to consolidate existing knowledge. It will also benefit those working in pharmacovigilance, as well as those who support or interact with pharmacovigilance from areas including medical information, regulatory affairs, clinical, sales and marketing, legal, commercial and quality.
