Product Types

Sponsors of clinical studies and holders of Marketing Authorisations for medicinal products are required to continuously monitor the safety of trial subjects and patients and meet ever more stringent regulatory requirements.

In addition, the Post-marketing Surveillance and Vigilance reporting requirements for medical devices have recently been formalised with the implementation of a more structured EU-wide vigilance system.

Whether you are planning a new Marketing Authorisation Application, have new or established medicinal products on the market, or are working with investigational medicinal products or with medical devices, the team at Wainwright Associates have many years of experience of vigilance work with the knowledge and the contacts as specialist consultants to assist you in meeting your vigilance obligations.

We can work on an on-going or ad hoc basis to address your specific needs.

Clinical Study Safety

Wainwright Associates can assist with your clinical trial safety processes, from design and setup of safety procedures, to the creation and review of Serious Adverse Event narratives, reporting Suspected Unexpected Serious Adverse Reactions (SUSARs) to the national Competent Authorities and Ethics Committees and the creation and submission of Annual Safety Reports.

In addition, we can advise on or create safety updates to Investigator Brochures and Investigational Medicinal Product Dossiers (IMPDs) or create bespoke safety reviews in response to regulatory authority requests.

Post-Marketing Vigilance

The vigilance 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 can advise and assist with the processes described therein including:

• 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 Holders products.

• Preparation and submission of Periodic Safety Update Reports.

Qualified Person for Vigilance (QPPV)

The appointment of a Qualified Person for Vigilance (who must be resident in the European Economic Area) is a legal requirement. 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.

Risk Management & Vigilance Plans

One specific area of focus for EU Member State Competent Authorities at present, is that of risk management and vigilance 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 Vigilance Plans.

Audits & Vigilance Inspections

It is a requirement that vigilance systems should be audited. Our team, who have recent experience of supporting companies through the Competent Authority inspection process, can audit your system and provide recommendations for improvements where necessary.

We can also help you to prepare for Competent Authority vigilance inspections, including preparation of the pre-inspection documentation and assistance during the inspection itself. We can work with you to prepare your response to any inspection findings.

Vigilance Training

All staff involved with vigilance activities, including sales representatives and administrative staff must be able to demonstrate that they have been appropriately trained. We can prepare and deliver bespoke vigilance training to help you meet the specific needs of your organisation.

Standard Operating Procedures

All vigilance procedures must be fully documented, usually by way of Standard Operating Procedures (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.

Medical Devices

As of January 2008 new EU guidelines on the Medical Device Vigilance System came into effect in order to facilitate a uniform application of the requirements described in the three EU Medical Device Directives. Wainwright Associates can assist with the required Field Safety Corrective Actions and the creation of Field Safety Notices and notification to EU Member State Competent Authorities.