Adis publishes white paper on the changing faces of device safety

Wendy McNeely, Product Development Specialist for Adis Business Intelligence, has recently authored a paper on the changing guidelines for medical device safety and the implications for manufacturers.

The paper acknowledges the increased workload related to gathering real-world performance data once a device is on the market, but stresses that there are many benefits to be attained from proactive literature monitoring throughout the lifecycle – from helping to cut costs and time to market to gaining a competitive advantage.

benefits
Benefits of proactive literature monitoring for device safety

Some high-profile cases of safety issues with medical devices from the last decade are also highlighted, demonstrating the need for manufacturers to do all that they can to decrease the risk of devices causing harm once they get to market.

The full paper is available to download here .

Adis launches expanded range of services to support pharmacovigilance departments

Adis Pharmacovigilance will help pharmacovigilance teams to face the challenges of regulatory literature monitoring

pv-bubbles-zoomed

Under the name of Adis Pharmacovigilance, Adis, a leading global provider of drug information, has launched an expanded range of services to support pharmacovigilance departments. This new suite of services includes monitoring special situation Individual Case Safety Reports (ICSRs), local literature and customised source coverage, ongoing safety monitoring, and aggregate reports, PSURs and annual reports.

When Adis started out as an outsourcing partner for pharmacovigilance, its primary offering was centred on ICSR monitoring, which involves searching the literature to identify potential ICSRs related to a pharmaceutical company’s drugs.

Suzanne Berresford, Product Manager for Pharmacovigilance at Adis, explains:

“We work very closely with our customers to understand their unique situations, current set-up and requirements, and to design fully-customised solutions that make the most of our combined manpower and expertise. The expanded range of services we now offer reflects the success of this partnership approach – as our customers’ needs and regulatory requirements have changed, we have been able to adapt the way in which we support them”

Pharmacovigilance is concerned with identifying and reporting the adverse effects associated with the use of pharmaceutical products. Each company that has one or more drugs on the market has a regulatory requirement to conduct pharmacovigilance activities. A major part of this involves regularly monitoring the literature to identify and triage reports of adverse effects related to their products.

The European launch of Adis Pharmacovigilance will take place on 14 September 2016 at the World Drug Safety Europe congress in Munich. Mirko Walter, Director of Product Management for Adis Business Intelligence will deliver the plenary keynote speaking slot on the second day of the meeting, exploring the impact of the EMA MLM service and options for integration.

Mirko tells us:

“This is a great opportunity for us to meet with customers new and old to discuss some of the challenges they are facing. We know that the EMA MLM service has raised many questions within the industry and we look forward to sharing our experience to date of integrating this into workflows”

Adis Pharmacovigilance is the expert solution for regulatory literature monitoring offering a wide range of services and personal support every step of the way. Adis has been publishing pharmacovigilance and drug safety content for more than 30 years and for the last decade has applied this expertise to helping pharmaceutical companies with their global regulatory literature monitoring needs. More information can be found here.