News
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.
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:
- Define what is a medical device.
- Recognise the reasons for the two new Regulations.
- Understand the key aspects of the new legislation.
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 global march of deregulation in all professions, including deregulation in the pharmaceutical industry;
- The move of university training for pharmacists to strengthen education in clinical (patient oriented) pharmacy, and downgrade emphasis on pharmaceutical technology (pharmaceutical manufacturing, pharmaceutics) subjects.
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.
LEO Pharma are recruiting for a permanent senior position in the Manufacturing, Science and Technology Finished Goods department (MSAT FG). This involves the management of process development and technology transfer projects and the provision of technical support.
The successful candidate will have:
- an honours degree in pharmacy
- 3 years’ experience in product/process development or related post-graduate research
- excellent teamwork skills as well as being capable of working on his/her own initiative
- strong capabilities with respect to dealing with ambiguity
- excellent collaboration and communication skills.
Please apply with a recent CV via the following link https://my.hirehive.io/leopharma/jobs/32741/manufacturing-science-and-technology-finished-goods-msat-fg-senior-professional-p5-dublin
The HPRA are currently recruiting for a number of positions that may be of interest to pharmacists with different experience.
For further details, see http://www.hpra.ie/homepage/about-us/recruitment
In the final edition of the EIPG Journal in the current form, some of the topics covered include:
- Regulatory consequences of cata integrity failures
- Revisions made to European Pharmacopoeia sterilisation chapters
- Predicting production tablet properties from small scale manufacture
- Qualification of visual inspection of parenteral products.
Here is a link to the publication EIPG Journal #35 Dec 2017.
Pharmacists selected to participate in the 2017/18 ePortfolio Review are reminded that the closing date for submission of their ePortfolio extract is Sunday 28 January 2018.
There are a wide variety of resources available on the IIOP Website which you help you when preparing your extract for review, including information on the 2017/18 ePortfolio Review Standards.
If you require any support in relation to ePortfolio Review, please contact the IIOP on 01-4025112 or info@iiop.ie.
PIER is organising a careers evening in UCC Aula Maxima for undergrads, interns and pharmacists interested in careers in the pharmaceutical industry.
The event will take place on Thursday evening 1st Feb 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 seven focus areas (Commercial, Manufacturing/Tech Services, Market Access, Medical, Drug Safety/Pharmacovigilance, Quality & Compliance, Regulatory Affairs) where they can learn about some of the interesting careers in industry by chatting to pharmacists working in the particular area. Companies being represented include Accord, AbbVie, Biomarin, CUH-MRF, Eirgen, Genzyme, HPRA, Lilly, MSD, Perrigo, Pfizer, QM Specials, Recordati, Regeneron, Roche & Sanofi.
Email piercareerevents@gmail.com to register.
For further details see: PIER UCC Careeer Evening_1st Feb 2018.
Continuing on with the PIER Career Focus webinars highlighting some of the careers that pharmacists hold in industry, Peter Twomey (HPRA) will present on ‘Role of an Inspector with the HPRA’ on Thursday 11th January 2018 at 7.30pm. For further information, see Peter Twomey Career Focus Webinar_11th Jan 2018.
To register, email education@pier.ie.
Useful Links
- Academy of Pharmaceutical Sciences (APS)
- European Industrial Pharmacist Group (EIPG)
- European Industrial Pharmacists Group Newsletter
- European Medicines Agency (EMA)
- Health Products Regulatory Authority (HPRA)
- Irish Institute of Pharmacy (IIOP)
- Irish Medical Device Association (IMDA)
- Irish Pharmaceutical Healthcare Assocation (IPHA)
- Pharmaceutical Managers Institute (PMI)
- Pharmachemical Ireland
- The Pharmaceutical Society of Ireland (PSI)
- UK & Ireland Controlled Release Society (UKICRS)
- The Organisation for Professionals in Regulatory Affairs (TOPRA)