Pharmacovigilance in the Middle East: Adis PV attends the regional ISoP meeting

Pharmacovigilance in the Middle East: Adis PV attends the regional ISoP meeting

Springer Nature sponsored the annual meeting of the International Society of Pharmacovigilance (ISoP) Middle East Chapter under the Adis Pharmacovigilance brand, held on the 20th of September 2018 in Dubai. ISoP is an international non-profit organisation which aims to promote pharmacovigilance and enhance the safety and proper use of drugs worldwide. Continue reading “Pharmacovigilance in the Middle East: Adis PV attends the regional ISoP meeting”

The World Drug Safety Congress in Amsterdam addresses key challenges

The World Drug Safety Congress in Amsterdam addresses key challenges

Adis Pharmacovigilance attended the World Drug Safety Congress in Amsterdam on Sept 10th and 11th.

The event has been running for over a decade and is world renowned for its ability to connect key stakeholders in the drug safety field, as well as for leading the way in moving the sector forward.

Senior level drug safety professionals, as well as representatives from sponsors and service providers, met to discuss key topics and showcase solutions.

This year’s theme, Addressing Key Challenges for Safety Professionals, had us prepared for a series of interesting presentations and discussions on the ever growing importance of pharmacovigilance and the challenges connected with ensuring patient safety. Continue reading “The World Drug Safety Congress in Amsterdam addresses key challenges”

Revolution, innovation, and collaboration: report from the World Drug Safety Congress

Revolution, innovation, and collaboration: report from the World Drug Safety Congress

Although automation and artificial intelligence were yet again some of the buzz words at this pharmacovigilance conference, I was even more interested to hear other perspectives on how the industry is changing and what initiatives are being implemented in order to adapt to this environment. The World Drug Safety Congress US took place in Philadelphia on 10-11 April with over 350 attendees and over 100 speakers. Continue reading “Revolution, innovation, and collaboration: report from the World Drug Safety Congress”

Using state-of-the-art technology to combat challenges unique to 21st century culture

Using state-of-the-art technology to combat challenges unique to 21st century culture

Since I now have a piqued interest in the application of artificial intelligence in pharmacovigilance, I was interested to read the findings from a study using machine learning to identify ICSRs in social media.  Until now, my impression of ADRs reported in the social media was that identifying valid ICSRs was more than challenging due to their diversity, complexity, colloquialisms and anonymity. Also, it seems the regulatory authorities acknowledge these challenges as it is not yet a regulatory requirement to monitor social media as a source for ICSRs. But is this looking set to change if machine learning and automation become the norm? Continue reading “Using state-of-the-art technology to combat challenges unique to 21st century culture”

Why rise of the machines will be beneficial in the pharmacovigilance world

Why rise of the machines will be beneficial in the pharmacovigilance world

Automation, machine learning, artificial intelligence, robots – hearing such terms mentioned in the workplace can strike fear in the everyday employee, that soon the human workforce will be replaced entirely by a ‘digital workforce’. And of course many sci-fi movies only play on this hype. Whilst in certain industries or for specific job roles there may be more than an element of truth to this, in the pharmacovigilance world, using machines to supplement human input is not only a necessity but also a blessing. Or so I learnt at the International Society of Pharmacovigilance (ISOP) Seminar on Intelligent Automation in Pharmacovigilance, held in Boston in December 2017. Continue reading “Why rise of the machines will be beneficial in the pharmacovigilance world”

The Year of the Dog: If you can’t run with the big dogs, stay on the porch

The Year of the Dog:  If you can’t run with the big dogs, stay on the porch

Report from the DIA’s Pharmacovigilance and Risk Management Strategies Conference, Washington, DC, 22-24 January 2018

Despite the US government shutdown resulting in a noticeable absence of FDA personnel, the DIA’s Pharmacovigilance and Risk Management Strategies conference was a well-attended event. The conference was hosted in Washington, DC, from 22-24th January 2018. As usual the programme was excellent, extensive and covered many hot topics; a recurring theme was how quickly some players in the PV industry are adapting to modern-day challenges including newer technologies for treatment, so-called big data, seemingly incessant social media and the rise of artificial intelligence. Continue reading “The Year of the Dog: If you can’t run with the big dogs, stay on the porch”

E2B R3: the countdown is over

E2B R3: the countdown is over

After many years of planning, on 22nd November 2017 the EMA’s EudraVigilance system started accepting ICSRs submissions in the E2B R3 format. This was one amongst many changes made to EudraVigilance on this date, but implementation of R3 is certainly one of the most significant milestones. The switch from R2 to R3 is not simply a technical format change, but has potential upstream and downstream effects on case processing and other PV activities. Although there will be expected challenges in transitioning to a new ICSR format, there may also be unexpected benefits. Continue reading “E2B R3: the countdown is over”

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?”

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?”