PIER in collaboration with EIPG are organising a webinar on the topic of 'Data Integrity' on Tues 11th December 2018 at 4pm GMT. The speaker is Dr Alessandro Regola who has extensive experience in GMP and quality systems. The session will be chaired by Dr Piero Iamartino, EIPG Vice-President, Technical and Professional Development.
Overview of Webinar: The presentation will cover the issue related to the integrity of GMP relevant data that the pharmaceutical industry has been struggling with for the past 5-7 years mainly due to violations recorded during Authority inspections to pharmaceutical (both API and drug product) manufacturing facilities. Most common and frequent compliance issues related to paper, IT or hybrid (paper+ IT) systems will be discussed. A recommended risk assessment and remediation approach will be presented, including the classification of affected system based on risk for the quality of the product and the patient health, the evaluation of the gaps and the prioritisation of corrective actions.
For further details on the webinar and how to register, see EIPG PIER webinar on Data Integrity_11th Dec 2018.
PIER is delighted to announce that its 2018 Autumn CPD meeting & AGM will take place on Sat 1st Dec 2018 in Clayton Liffey Valley, Dublin (9.30pm-1pm). The theme of the CPD meeting is 'Insights into Rare Diseases'. Great speakers from Genomics Medicines Ireland (GMI), HPRA and Vertex will be presenting.
To register, email education@pier.ie.
PIER is organising a careers evening in RCSI College Hall for undergrads, interns and pharmacists interested in careers in the pharmaceutical industry.
The event will take place on Wednesday evening 7th November 2018. The formal part of the evening will run from 6.30pm-9.00pm with refreshments available from 6.00pm.
Attendees will be invited to rotate around nine focus areas (Commercial, Consulting, Manufacturing/Tech Services, Market Access, Medical, Drug Safety/Pharmacovigilance, Quality & Compliance, HPRA, Regulatory Affairs) where they can learn about some of the interesting careers in industry by chatting to pharmacists working in the particular area.
Email careerhub2@rcsi.ie to register.
For further information see, RCSI Careers Evening 7th Nov 2018.
PIER in collaboration with EIPG are organising a webinar on the topic of 'Integrated Quality Management Systems'. The presenter is John Jolley (PharmaConsult Global) and will be held on Monday 15th October at 4pm (GMT).
In his talk on the requirements of an Integrated Quality Management system, John will include the principles of applying quality risk management, the management of product and process deviations, CAPA and change control, audit management of inspections and the management of enterprise resource planning and supplier quality management.
Numbers are limited and are on a first come, first serve basis. Anyone registering to attend and then finding they are unable to do so must cancel their participation before the event.
For further information, see Integrated QMS webinar_15th Oct 2018.
PIER in collaboration with EIPG are organising a webinar on the topic of 'FMD Implementation- Insights from a National Medicines Verification Organisation'.
The deadline for the implementation of the Delegated Regulation on Safety Features is fast approaching and industrial pharmacists throughout the entire pharmaceutical regulatory and supply chain will be interacting closely with their NMVO in the coming months. This webinar will provide insights into how an NMVO operates and an understanding of the importance of collaboration between all players and their national MVO, as part of the European network, in order to ensure the success of this project. The presenter is PIER member Leonie Clarke, Project Manager IMVO. It will be held on Tuesday 25th September at 4pm GMT.
Numbers are limited and are on a first come, first serve basis. Anyone registering to attend and then finding they are unable to do so must cancel their participation before the event.
For further information, see FMD webinar_25th Sept 2018.
PIER will be holding a careers information event in RCSI College Hall on Wednesday 7th November 2018 from 6.30pm.
TOPRA (the organisation for professionals in regulatory affairs) has postponed its planned Career Fair in DCU on 6th June 2018 until 2019. PIER will update members once a new date has been decided.
Please join us for the PIER Summer BBQ in McGrattans, Fitzwilliam Lane, off Baggot Street, Dublin on Friday 29th June 2018 from 7.30pm.
RSVP to membership@pier.ie by Wednesday 27th June 2018.
TOPRA (the organisation for professionals in regulatory affairs) are holding their Careers Fair in Dublin this year as well as London. It is a really good opportunity for both students, and other professionals looking to move into regulatory affairs, to come along and learn about the different career opportunities in this field of the pharmaceutical industry.
More information can be found on the TOPRA website: https://www.topra.org/regulatorycareersdublin
The event is free to students who are members of TOPRA (student membership is about £35 - the same cost for a student to register for the event if they are not members).
Dublin City University Pharmaceutical Regulatory Symposium & Webinar on the topic of 'Exploring Current Trends in Active Pharmaceutical Ingredients Manufacture, Control and Regulation' will take place in DCU Alpha Campus, Glasnevin on Wednesday 9th May 2018. PIER members can avail of a 20% discount on registration fees.
For further details, see API Symposium_9th May 2018.
