Service Types

The pharmacovigilance requirements for the European Union are provided in great detail in the 200-plus pages of Volume 9a of the Rules Governing Medicinal Products in the European Union. Wainwright Associates can guide you through the complexities of Volume 9a and advise and assist with the processes described therein including:

• The collation, assessment, follow-up and reporting (including electronic) of spontaneous adverse drug reactions received by the Marketing Authorisation Holder.
• Routine literature searching to identify potential adverse events related to the Marketing Authorisation Holder's products.
• Preparation and submission of Periodic Safety Update Reports.

Case Processing

Wainwright Associates can help your company with case processing through:

• Managing the receipt and assessment of spontaneous reports, literature reports and regulatory authority reports
• Prepare case narratives
• Manage your database entry
• Request  follow-ups
• Expedited reporting, inc. EVWEB entry
• Case reconciliation

Qualified Person for Pharmacovigilance (QPPV)

The appointment of a Qualified Person for Pharmacovigilance (who must be resident in the European Economic Area) is a legal requirement  for EU Marketing Authorisation Holders. The legislation allows the QPPV function to be contracted out and one of our appropriately qualified and experienced consultants can carry out this role on your behalf. The QPPV will be responsible for:

• Ensuring an appropriate system of pharmacovigilance is in place
• Maintaining an oversight of the safety profile of relevant products
• Preparation of  literature search strategies
• Conduct of weekly literature searches for possible adverse event reports
• Being the central point of contact for the authorities and pharmacovigilance inspectors
• Ensuring all Standard Operating Procedures (SOPs) are in place and working

Periodic Safety Update Reports

Wainwright  Associates can Prepare PSURs in accordance with ICH E2C on behalf of clients or offer assistance to clients with preparation of their PSURs

Risk Management & Pharmacovigilance Plans

One specific area of focus for EU Member State Competent Authorities at present, is that of risk management and pharmacovigilance planning. Once an investigational medicinal product is approaching the Marketing Authorisation Application stage we can assist with the creation and development of the required Risk Management and Pharmacovigilance Plans.

Standard Operating Procedures

All pharmacovigilance procedures must be fully documented, usually by way of SOPs. We can assist you in the preparation of such SOPs, either by advising on content, reviewing draft SOPs or preparing SOPs on your behalf according to your particular requirements.