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). 

Sanofi Waterford is currently recruiting for an Regulatory Site Officer for their Regulatory Affairs Department. Position may be suitable for Pharmacists making transition across to industry.

For further details, see the job description Sanofi Regulatory Site Officer.

For enquries/applications, contact Jadwiga.Zmuda-ext@sanofi.com

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

Astellas is currently recruiting for an Affiliate Lead for their Regulatory Affairs Department.

For further details, see the job description Astellas RA Affiliate Lead position

The PIER Spring CPD meeting will take place in Trinity School of Pharmacy (Lecture Theatre LTEE1 (to the right and down the stairs on entering the Panoz Institute)) on Thursday evening 19th April 2018 from 7pm. The theme of the meeting is 'Getting the balance right in market access to medicines'. Speakers include

  • Dr Máirín Ryan (HIQA),
  • Dr Róisín Adams (NCPE)
  • Muireann McAlister (Pfizer)

Registration & refreshements from 6.30pm in the Atrium area. 

To register, please email education@pier.ie before Tuesday 17th April 2018. Attendance is free for current PIER members. 

The 2018 QP Forum will be held in TCD School of Pharmacy on Thursday 12th April 2018.

For further details regarding the agenda and registration, see https://pharmacy.tcd.ie/postgraduate/QPForum.php

Continuing on with the PIER Career Focus webinars highlighting some of the careers that pharmacists hold in industry, Donal MacConaill (Veeva Systems & Pharmabuddy.ie) will present on career opportunities in Health IT on Monday 9th April 2018 @ 7.30pm. For further details, see Career Opportunities in Health IT

To register, email education@pier.ie.

Continuing on with the PIER Career Focus webinars highlighting some of the careers that pharmacists hold in industry, former PIER Chair Stan O'Neill (The Compliance Group) will present on career opportunities in quality on Tuesday 27th March 2018 @ 4.30pm (note change of time). For further details, see PIER Career Focus 'Quality Career Opportunities'

To register, email education@pier.ie.

The PIER Committee invites you to a speed networking event in Doheny & Nesbitt (Cellar Bar) on Baggot Street on Friday 23rd March 2018 from 7.30pm. RSVP membership@pier.ie by Thursday 22nd March 2018.

PIER members are invited to provide comments on the revision of Eudralex Volume 4 ANNEX 1, Manufacture of Sterile Medicinal Products. These comments will be provided to the EIPG who will collate the feedback received from member organisations and send to the European Commission and the EMA. The consultation document can be accessed via the link below. Please provide your feedback to education@pier.ie before 4th March 2018.

https://ec.europa.eu/health/sites/health/files/files/gmp/2017_12_pc_annex1_consultation_document.pdf

Annex 1 was first published in 1971, since then it has undergone a number of targeted updates but, until now it has not undergone a full review. This revision is intended to add clarity, introduce the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes and to change the structure to a more logical flow. Key changes are:

  • Introduction of new sections: scope, utilities, Environmental and process monitoring sections and glossary
  • Introduction of QRM Principles
  • Restructured to give more logical flow
  • Added detail to a number of the previous sections to provide further clarity.

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