Author Archives: Elaine Harris

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The First Dublin City University Pharmaceutical Regulatory Symposium March 15th

DCU is working in partnership with the European Directorate of the Quality of Medicines and Healthcare (EDQM) in Strasbourg to host an event focused on  regulatory aspects of active substance manufacturing.

The event aims to provide attendees with discussion and analysis on the current “hot topics” in active substance regulation (risk management, definition of starting materials, elemental impurities, mutagenic impurities) . The theme for the Symposium is:

“Using process knowledge and Risk Management Tools to build an effective control strategy for drug substance manufacture”

The topics will be presented by regulatory experts in each relevant field from the EDQM and the HPRA.

The event itself will be chaired by Dr. Michael Morris (former HPRA / Former Chair of the European Pharmacopoeia Commission).

Further details, including the Agenda, can be found at the following link:

https://www.eventbrite.com/e/dublin-city-university-pharmaceutical-regulatory-symposium-webinar-tickets-31410510683?aff=INVENT

If you would like to find out more about the event, please do not hesitate to contact

Dr. Kieran Nolan – Head of School of Chemical Sciences DCU – 01-7005913

Ciaran Feeney – EDQM – 0033 (0)6 12 15 85 02


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“The Future of (Bio)Pharmaceutical Manufacturing” February 28th, Brussels

Elaine Harris will attend this high level seminar whose objective is to bring together policy- and decision-makers, industry R&D and academia, and other relevant stakeholder organizations in order to discuss a roadmap for innovation in (bio)pharmaceutical manufacturing. Attendees and speakers will include Barry Heavey (IDA), Rainer Fischer (Fraunhofer IME), Sean Kelly MEP, Mark Ferguson (Chief Science Advisor to the Government of Ireland), Seamus Malone (Eli Lilly),Yvonne Van Megan (Janssen Biologics B.V.), Padraig Somers (Helsinn), Ian Jones (Innopharma Labs)
http://iscintelligence.com/event.php?id=311


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Recent publication by E Harris on the use of social media for ADR reporting

Category : Publications

A recent publication in the Journal of Pharmacovigilance by Elaine Harris (Innovation 21) and Ishak Omar (Quintiles IMS) discusses the potential benefits of using social media for Adverse Drug Reaction (ADR) reporting. Results  from the study indicate that a collaborative effort is required between the pharmaceutical industry, HCPs and the public before social media can reach its full beneficial potential as a tool in Pharmacovigilance. https://www.esciencecentral.org/journals/the-use-of-social-media-in-adr-monitoring-and-reporting-2329-6887-1000223.php?aid=83486view=mobile


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