Sponsors of clinical trials 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 formalised 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 experienced team at Wainwright Associates have the knowledge and the contacts as specialist consultants with which to assist you in meeting your pharmacovigilance obligations.

Clinical Trial Safety

In accordance with the Clinical Trials Directive (2001/20) sponsors of clinical trials in the European Union are required to monitor the safety of all clinical trial subjects and to collect and assess Serious Adverse Events (SAEs) for expedited and periodic reporting to the European Union Member State Competent Authorities and to the appropriate Ethics Committees.

Wainwright Associates can assist throughout the entire process, 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 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.

One specific area of focus for EU Member State Competent Authorities at present, when considering Marketing Authorisation Applications (MAAs), is that of risk management and pharmacovigilance planning. Once an investigational medicinal product is approaching the MAA stage we can assist with the creation and development of the required risk management and pharmacovigilance plans.

Post-Marketing Pharmacovigilance

Directive 2001/83/EU (as amended) includes the specific instruction for Marketing Authorisation Holders to put in place a system of pharmacovigilance to enable the collection of information for the surveillance of medicinal products.

The requirements 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.

The appointment of a Qualified Person for Pharmacovigilance for the European Union is a fundamental requirement of a pharmacovigilance system. Whilst we advise that a Marketing Authorisation Holder should appoint a suitably qualified person from within their own organisation, where this is not possible we can provide the services of an appropriate Qualified Person for Pharmacovigilance.

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.

Additional Pharmacovigilance Services

Wainwright Associates are also able to offer a number of other services related to pharmacovigilance including:

• Provision of pharmacovigilance training for the Clients organisation (including sales representatives).
• Auditing existing pharmacovigilance systems and the provision of recommendations.
• Preparation for, and assistance during, MHRA pharmacovigilance inspections.