1998 Shirov: Bishop to h3! Dubbed an all-time strategic chess move… How do future pharmacovigilance strategies compare?

1998 Shirov: Bishop to h3! Dubbed an all-time strategic chess move… How do future pharmacovigilance strategies compare?

Report: Pharmacovigilance Strategy Meeting, Boston, MA, USA November 2017

In less time than it took for me to travel to the meeting from New Zealand – the day was over! Hard to believe that within a short eight hours, 25 lively roundtables were conducted, two keynote speeches were delivered, and the panel discussed the learning of the day, including challenges of monitoring diverse sources, importance of real-world evidence in the context of risk benefit, and the game-changing impact of artificial intelligence. Continue reading “1998 Shirov: Bishop to h3! Dubbed an all-time strategic chess move… How do future pharmacovigilance strategies compare?”

Fail Early, Fail Fast – and increase Likelihood of approval with biomarkers

Fail Early, Fail Fast – and increase Likelihood of approval with biomarkers

Our partners Amplion recently published an interesting blog post on the benefits of biomarkers in informing earlier decisions in the drug development process – “fail early, fail fast” to save time and money, and increase approval success. An interesting read, check it out! Continue reading “Fail Early, Fail Fast – and increase Likelihood of approval with biomarkers”

Date announced for next safety biomarkers webinar

Date announced for next safety biomarkers webinar

The second in a two-part series of live webinars on Pharmacovigilance and Safety Biomarkers is set to take place on Tuesday, March 21, 2017.

Joining forces with Amplion, the leading biomarker business intelligence company, we aim to provide useful insights for anyone involved in R&D, product strategy decisions, or working directly in a drug safety related role.

During the webinar, our speakers will cover: Continue reading “Date announced for next safety biomarkers webinar”

A brave new world: what does the future hold for pharmacovigilance?

A brave new world: what does the future hold for pharmacovigilance?

Report from the DIA Pharmacovigilance and Risk Management Strategies Conference, January 23-25, 2017, Washington, DC.

Written by Suzanne Berresford, Product Manager, Pharmacovigilance, Springer Nature

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Report author, Suzanne Berresford

The nature of medicinal products is in a rapidly shifting world, with therapeutic innovation becoming a major global trend that is here to stay. The precision medicine approach and use of targeted therapies such as biologicals, gene therapy and stem cell therapy is weaving its way into standard practice but questions still remain about monitoring the long-term safety and efficacy of such advanced therapies. The DIA Pharmacovigilance and Risk Management Strategies Conference set out to discuss some of the challenges and to provide an opportunity for pharmacovigilance professionals to share their experiences in these areas. Continue reading “A brave new world: what does the future hold for pharmacovigilance?”

Adis brings together expert speakers for special webinar on safety biomarkers

The team behind AdisInsight are working in collaboration with their latest partners, Amplion, to host a special live webinar on December 13, 2016, on the topic “Pharmacovigilance and Safety Biomarkers”.

Safety biomarkers offer potential benefits throughout the drug lifecycle. These range from the identification of drug candidates most likely to be tolerated in humans, through to predictive identification of patients most likely to benefit from, or not be harmed by, a treatment.

The webinar will provide an introduction to biomarkers, their characteristics, and current uses in drug safety. Information presented will be of interest to those working in pharmaceutical/biotechnology industries and adjacent markets – including those working in R&D, making strategic decisions, or directly involved in drug safety.

Guest speakers for the session include Nitin Joshi, Editor of Drug Safety – the official journal of the International Society of Pharmacovigilance (ISoP), which is published by Adis.

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Speaker profiles

Registration is free and open to all via the information page: http://www.springer.com/gp/adis/pharmacovigilance-and-safety-biomarkers

The December session will be the first in a two-part series on this topic, the second part of which will be held in late January 2017.

Meeting report: 3rd Annual Risk Management and Pharmacovigilance Summit, Vienna

Meeting report: 3rd Annual Risk Management and Pharmacovigilance Summit, Vienna

Colleagues from SpringerNature recently took part in the 3rd Annual Risk Management and Pharmacovigilance summit in Vienna, with the following meeting report provided by Daniela Ranzani, Adis Business Intelligence Product Manager.

Traditional topics as well as best practice and case-study presentations remain at the core of the meeting, allowing attendees to share knowledge and diverse experiences. Regulation revisions were also discussed, with a spotlight on the GVP Modules V and IX updates. Attention to patients with dedicated programs was highlighted, and a presentation on social media listening reminded us all of the great power represented by such tools when used for PV, which also brings great challenges in terms of carefully managing this type of information. Continue reading “Meeting report: 3rd Annual Risk Management and Pharmacovigilance Summit, Vienna”

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.

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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

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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.

Adis unveils a bold new look for pharmacovigilance at DIA

Two members of the Adis Product Management team have recently returned from the DIA Annual Meeting in Philadelphia where they officially launched Adis Pharmacovigilance to 7,000+ attendees.

For more than a decade, Adis has provided regulatory literature monitoring services under the name of Reactions Pharmacovigilance Service. This range of customizable outsourcing solutions includes ICSR monitoring, local literature monitoring and annual reports. The service has now been re-launched with a new name – Adis Pharmacovigilance .

A champagne reception was held during the DIA meeting to celebrate the official launch and the event attracted many visitors to the Springer Nature stand. The conference itself presented many opportunities for the team to speak to attendees about their current pharmacovigilance set-up and needs.

James DeFalco, Executive Licensing Manager, speaking with delegates during the champagne reception. 
Suzanne Berresford, Product Manager for Adis Pharmacovigilance, at the Springer Nature stand.

Over the coming weeks the Adis team will be preparing for a further three pharmacovigilance-related conferences– World Drug Safety Europe in Munich, the 3rd Annual Risk Management & Pharmacovigilance Summitin Vienna, and the ISoP Annual Meeting which will take place in Agra, India.

Further information about Adis Pharmacovigilance is available on the landing pageadis.com/pharmacovigilance.