Safety strategies and efficiencies – what is the best solution?

Safety strategies and efficiencies – what is the best solution?

This was the subject of many discussions at the recent World Drug Safety Congress Americas 2019 in Philadelphia. As has been the case at many pharmacovigilance meetings in the last few years, artificial intelligence, outsourcing solutions and automation were hot topics, with debates over the future use of such strategies to achieve operational efficiency whilst strengthening patient safety. Continue reading “Safety strategies and efficiencies – what is the best solution?”

DIA India 2019: Regulatory Trends in Clinical Safety & Pharmacovigilance (An EU perspective).

DIA India 2019: Regulatory Trends in Clinical Safety & Pharmacovigilance (An EU perspective).

This first session of the conference, chaired by J Vijay Venkatraman, gave the audience a broad overview of the state of flux in pharmacovigilance, essentially resulting from changes initiated in Europe – the impact of evolving Eudrovigilance, Brexit and E2B R3 were the focal points. Continue reading “DIA India 2019: Regulatory Trends in Clinical Safety & Pharmacovigilance (An EU perspective).”

Planning and strategizing in the face of evolving regulatory guidelines: Report from the DIA Pharmacovigilance and Risk Management Strategies Conference (PVRMS19)

Planning and strategizing in the face of evolving regulatory guidelines: Report from the DIA Pharmacovigilance and Risk Management Strategies Conference (PVRMS19)

The PVRMS19 was presented at the Omni Shoreham Hotel, Washington DC, January 2019. During the packed three-day event, we learned that many aspect governing the development and subsequent safe and effective use of medicines are in a state of flux… and so they should be. As we learn by our actions (triumphs and failures) we make adjustments to enhance the future investigations and create medicinal agents that are effective and safe, or more precisely, have a benefit that outweighs the risks. Continue reading “Planning and strategizing in the face of evolving regulatory guidelines: Report from the DIA Pharmacovigilance and Risk Management Strategies Conference (PVRMS19)”

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”