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.

Adis to unveil a new-look service for pharmacovigilance

Adis will reveal a brand new look for its regulatory literature monitoring solution at the DIA Annual Meeting, taking place from June 26th to 30th in Philadelphia, USA.

For more than a decade, Adis has provided customized literature monitoring services to pharmacovigilance departments under the name of Reactions Pharmacovigilance Service. The outsourcing solutions offered include ICSR monitoring, local literature monitoring and annual reports. The service will be renamed as Adis Pharmacovigilance as part of the current rebranding initiative.

To celebrate the re-launch at DIA, a champagne reception will be held at the Springer Nature stand on the evening of Monday 27th June, immediately after the official conference opening ceremony. The event will be attended by Springer Nature colleagues including Director of Product Management for Adis Business Intelligence, Mirko Walter, and Product Manager for Pharmacovigilance, Suzanne Berresford, who will be on hand to speak to delegates about their literature monitoring needs.

Mirko explains:

“The Adis reactions portfolio has a very proud heritage and an enviable position as the industry leader in delivering pharmacovigilance content and solutions. The bold new branding reflects our ambitions in this area, in which we plan to continue growing and offering cutting edge, expert solutions for our customers.”

Adis is the industry leader with more than 30 years’ experience of delivering pharmacovigilance content and solutions to over 6,000 customers globally. Adis is a publishing imprint of Springer Nature, a scientific publishing company resulting from the May 2015 merger of Springer Science+Business Media and Georg von Holtzbrinck Publishing Group’s Nature Publishing Group, Palgrave Macmillan, and Macmillan Education.

Further information about Adis Pharmacovigilance can be found here.

Adis involved in the First EMR/Arab Countries meeting

Adis was pleased to be involved in a breakthrough pharmacovigilance event hosted by the Centre Anti Poison et de Pharmacovigilance du Maroc (CAPM), which took place on 22-26 September 2014 in Rabat, the capital city of Morocco.

The summit was organized by CAPM in association with the Moroccan Society of Pharmacovigilance (SMPV), the Council for International Organizations of Medical Sciences (CIOMS), the International Society of Pharmacovigilance (ISoP) and Springer.

The purpose of the meeting was to promote interaction, exchange information, implement and reinforce national pharmacovigilance activities in Arabic countries and define an action plan for its development.

Attendees of the meeting

Springer offers a range of products and services in drug safety and pharmacovigilance through the Adis brand, and got involved in the event with a view to understanding the needs of Arab countries when it comes to monitoring the safety of medicines, as well as possibly providing support and resources that may help with building awareness and respond to work and educational needs.

Daniela Ranzani, Product Manager for Pharmacovigilance at Adis, hosted a presentation on the challenges and trends in literature monitoring for pharmacovigilance and stated

“The content presented at this meeting was extremely valuable, as were the working groups that were established for discussion of topics such as integrated pharmacovigilance systems, harmonization of terminology and definitions, risk minimization plans and how to strengthen national pharmacovigilance systems for vaccines. We firmly believe that this was the first milestone in a series of events, whether they are discussion forums or educational workshops, and Springer is ready to engage further with this vital segment , to collaborate with centers in this region, and to provide them with any support and resources they may need.”

The meeting was also attended by Nadja Madani, Springer’s Licensing Manager for Health, Hospitals & Pharma in the region, who commented:

“We were very pleased to participate in the meeting, which had a rich programme including presentations and participation from several regional and international authorities, including the WHO, the US FDA, the Arab League, the Uppsala Monitoring Centre, experts from the Industry, representatives from national drug safety authorities and Health Ministries in the Arab region, amongst others. A special thanks goes to Rachida Soulaymani, Head of the Centre Anti Poison et de Pharmacovigilance du Maroc, for having us and to all of her wonderful staff and participants – we hope to see them all again soon.”

A full meeting report will be published soon in one of the Adis Journals.

Adis involved in a breakthrough pharmacovigilance summit

Adis is working in partnership with the Centre Anti Poison et de Pharmacovigilance du Maroc to host a special pharmacovigilance event for Arabic-speaking countries.

Adis is pleased to announce its involvement in an upcoming pharmacovigilance event, being hosted by the Centre Anti Poison et de Pharmacovigilance du Maroc (CAPM).

The summit, organized by CAPM in association with the Moroccan Society of Pharmacovigilance (SMPV), the Council for International Organizations of Medical Sciences (CIOMS), and the International Society of Pharmacovigilance (ISoP) will take place on 22-26 September 2014, and it is the first event of its kind in the region.

Morocco was the first Arabic country to join the International Pharmacovigilance Programme lead by WHO, and of the 22 countries belonging to the Arab League, 40% are currently official members. However, Arab countries representation in Vigibase amounts to only 0.4% of all individual case reports.

The purpose of this meeting is to interact, exchange information, implement and reinforce national pharmacovigilance activities in Arabic countries and define an action plan for its development.

Click here to read the first announcement and draft program. To register for the event, complete the registration form here or email the organizers at louammi@gmail.com