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Training - ISoP Seminar

ISoP Seminar
Boston, USA

4-5 December 2017

Intelligent Automation in Pharmacovigilance



ISoP Seminar – Intelligent Automation in Pharmacovigilance

Coordinator: Jan Petracek (ISoP Board member / ETP America)

Can automated processes powered by artificial intelligence provide effective solutions to the ever-increasing challenges in pharmacovigilance?
The volume and diversity of regulated safety data to be screened, compiled and analysed by Regulators and Licence Holders has been steadily increasing over the years and is anticipated to further increase, implying the need for resources to a problematic extent.
Thanks to recent progresses in Artificial Intelligence, it has become realistic to consider that automated and semi-automated processes have the potential to provide higher efficiency -and/or reduce cost- in the execution of the most burdensome pharmacovigilance activities, especially the screening, management and evaluation of individual case safety reports from an increasing diversity of sources, especially patient support programs and multiple social media.  However, relying upon process automation is a complex strategic decision, that requires careful in-depth critical evaluation involving specialised competencies.

In Boston, last December, ISoP offered a unique, highly focused, scientific and interactive two-day seminar that explored the emerging tools of potential interest for process automation in pharmacovigilance. Strengths, limitations, challenges for implementation and further evolutions were debated among relevant specialists.

This seminar was aimed to engage all interested pharmacovigilance professionals in an industry, regulatory, or university setting.

The programme covered topics such as:
– Case intake automation
– ICSR processing automation
– Signal management support tools
– Robotic process automation
– New skillset for careers in Pharmacovigilance
– Pharmacovigilance automation
– Pharmacovigilance insourcing and outsourcing model for industry 4.0

There was ample opportunity to exchange views and ideas in discussions both following individual presentations, after the panel discussion at the end of the seminar, and during coffee breaks.

The faculty consisted of international experts in pharmacovigilance, representing government, academia, and industry.
Training certificates of attendance were provided to those who complete the seminar.

This seminar was organized in Boston (USA) Massachusetts’ capital. It was the first time that such ISoP meeting had been undertaken in North America.

The International Society of Pharmacovigilance would like to extend its gratitude to Biogen for hosting the meeting at its premises, and to PrimeVigilance for their organizational support.
The seminar received very positive feedback and ISoP is hopeful that a follow up seminar can be held again.

Adis pharmacovigilance has now published a report from the seminar:
Blog Adis in-Touch (Author: Suzanne Berresford) – Click here

Participants at the ISoP Seminar, Boston 5 Dec


We are delighted to announce an outstanding faculty of international experts,
please check out the final programme available here

Meeting Venue

Biogen Building 8, 812 Auditorium (Floor 1)
Access through Biogen Building 9, 300 Binney Street, Cambridge, MA 02142

Biogen Building 8, 812 Auditorium
via Biogen Building 9
300 Binney Street,
Cambridge, MA 02142



For your stay in Boston, we recommend the following hotels (walking distance from meeting venue) – rooms subject to availability:

Residence Inn Boston Cambridge
120 Broadway, Six Cambridge Center Cambridge Massachusetts 02142 USA

Boston Marriott Cambridge
50 Broadway, Cambridge Massachusetts 02142 USA