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
Registration & refreshements from 6.30pm in the Atrium area.
To register, please email firstname.lastname@example.org 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 email@example.com.
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 firstname.lastname@example.org.
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 email@example.com 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 firstname.lastname@example.org before 4th March 2018.
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:
PIER is delighted to announce details of the first EIPG/PIER webinar of 2018 on the topic of 'Insight into New Medical Device Regulations in the EU' on Tuesday 13th March 2018 at 4pm (GMT).
Overview of Webinar:
EU legislation has been updated for both Medical Devices and In-vitro Diagnostic Medical Devices with major changes in the requirements such as clinical evaluation and performance testing. In parallel, Quality System Standards have been updated. Tightening regulations give more challenges for Medical Device companies throughout Europe. After attending this webinar, participants will be able to:
About the Speaker:
Petra Lehtinen MSc (Pharm) is Senior Regulatory and Quality Management Specialist at Biocodex PHAME (Pharmaceutical and Medical Services).
To Join the Webinar:
Please register for the event by filling out the form at https://docs.google.com/forms/d/e/1FAIpQLSdUBoelICCL0i5T_HgoF7K9Up1Ycxp3GimOcLuzfxyECdamQ/viewform. Further instructions will then be sent by e-mail. Attendance is free to current PIER members.
EIPG have requested that PIER members assist with a survey being carried out by Michael Anisfeld (Chair of the Industry Section of FIP). See some background information below.
As you may be aware, there is concern as to a potential future role for pharmacists in the pharmaceutical industry. This concern is evidenced by two factors:
The question needs to be asked is whether employing a pharmacist in the pharmaceutical industry adds value to the pharmaceutical industry.
Your input and assistance in answering these questions will be much appreciated. Please can you take about 10 minutes to answer the 16 questions in our survey?
To participate in the survey, please click on https://www.surveymonkey.com/r/BGG52TM.
Eirgen in Waterford are recruiting for a Regulatory Affairs Officer based at the R&D Centre in Waterford City. This is an entry level position which would be suitable for a pharmacist with some industry experience.
For further information, see Eirgen Regulatory Affairs Officer position Jan 2018.