Pharmacovigilance has become one of the most demanding aspects to both understand and comply with. This course will provide a concise overview of the pharmacovigilance function and the regulatory requirements.
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.
Why you should attend
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 Pharmcovigilance
Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.
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
- 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
Mr Graeme Ladds,
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.
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.
11 Thurloe Pl,
The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.
You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.