News
The first EIPG Webinar of 2021 will be held in conjunction with PIER and University College Cork on Wednesday 3rd February. It is entitled: “The Practical Implementation of EU Regulations for Medical Devices and in vitro Diagnostic Medical Devices”.
Regulation 2017/745 on Medical Devices (MDR) and Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR) were agreed at a political level between the three relevant European institutions (European Council, European Parliament and European Commission) and entered into force in May 2017. The Regulations have a staggered transitional period with some aspects becoming legally binding after 6 months of entry into force. The MDR was due to become fully applicable on 26 May 2020 after a three-year transition period. However, due to the global outbreak of Covid-19, full application of the MDR has been postponed and will become fully applicable on 26 May 2021. The IVDR will be fully applicable on 26 May 2022, after a five-year transition period.
The speaker is John Deavin, a pharmacist and Qualified Person who has been responsible for the registration of a large range of medical devices during his career in Regulatory Affairs.
Compliance with the general safety and performance requirements for labelling, technical documentation and quality management systems for medical devices will be some of the subjects discussed. The importance of clinical evaluation, classification of devices and the roles of the Competent Authorities, the European Commission, the Medical Device Coordination Group, Notified Bodies and EUDAMED will be explained.
See attached flyer for registration details EIPG MDR IVDR webinar_3rd Feb 2021. Please be aware that you will receive connection details for the webinar when you register and will need to keep the Zoom meeting details to join the webinar.
InPharma is a MSCA European Industrial Doctorate programme offering a comprehensive training program addressing the challenges of developing emerging drug candidates into new licensed medicines, including innovative modeling and bio-predictive tools tailored to streamline the oral drug product development process. InPharma brings together global pharmaceutical companies and leading research institutions together as a multi-sectorial team to deliver a unique research and training programme for 13 Early Stage Researchers (ESR) to complete their industrially based PhDs. It is a great opportunity for someone who would like to do their PhD at a university across Europe.See website for further details https://www.inpharma-network.eu/open-positions/.
The School of Pharmacy in UCC is one of the partner academic institutions and are currently recruiting for two positions (ideally a pharmacy graduate).
- ESR2: Modelling drug-excipient solubilisation interactions to predict excipient selection Host: Roche (Switzerland) & UCC (Ireland)
- ESR4: Molecular dynamics simulations to predict drug supersaturation in microemulsion formulations Host: UCC (Ireland)
For further information, see https://www.ucc.ie/en/hr/vacancies/research/full-details-1258321-en.html.
The deadline for the on-line application is 15 January 2021.
Applicants will only be notified if they have been shortlisted for interview by an InPharma recruitment committee. The selected candidates after interview will be expected to start their research as quickly as possible (target: February – April 2021).
The PIER Committee invite you to attend the 2020 AGM virtually on Tuesday evening 1st December 2020 from 8.30pm. All members welcome to attend.
A number of positions on the committee are available. Expressions of interest can be emailed to membership@pier.ie.
Register via https://docs.google.com/forms/d/1Dho1HM6iKtN-y71C15CG3cSI3SIyCI1zBg5drtja_ao/edit#responses
Continuing on with the PIER Career Focus webinars highlighting some of the careers that pharmacists hold in industry, Dr Eva Flavahan (Roche Holdings Ltd, UK) on 'Real-world Data Opportunities in Drug Development' on Friday 6th November 2020 @ 1.00pm. See event flyer for further information PIER Career Focus webinar Real-world Data Opportunities in Drug Development.
Register via this link https://docs.google.com/forms/d/1m2stRDXOhclIMpkyFSFF-sQF67ewZkDK7WSbUp4FNkA/edit
Acknowledging UCC School of Pharmacy for the continued technical support.
PIER is delighted to collaborate with EIPG for a webinar 'Advanced Therapy Medicinal Products (ATMPs)' on Tuesday 24th November 2020 @ 5.00pm. The speaker will be pharmacist Robert Smith who has worked in the area of ATMPs since 2006.
For further details on the event and the registration link, see the event flyer EIPG PIER 'Advanced Therapy Medicinal Products (ATMPs)' webinar_24 Nov 2020.
The Irish Pharmaceuical Healthcare Association (IPHA) who represents the international research-based pharmaceuical industry in Ireland are recruiting for a Health Data Analysis role. For further information about the role, see the job description IPHA Health Data Analyst Role.
Posted 11th Oct 2020
APPEL (Affiliation for Pharmacy Practice Experiential Learning) is now seeking expressions of interest from pharmacists in ALL practice settings who would like to facilitate an experiential learning placement for a 4th year pharmacy student next year.
Pharmacy students in Ireland now undertake a 5-year integrated masters programme to become qualified pharmacists. Key to this new programme are the experiential learning placements that students undertake throughout the course. In the 4th year of their studies, students have the opportunity to put their academic knowledge into practice in community pharmacy, hospital pharmacy, industry, academic, regulatory, and other practice settings.
There are 43 industry based placements (25%) for period August-December 2020. Most of these placements are based in Dublin and Cork but there are also placements in Galway, Kildare, Sligo, Tipperary and Waterford.
Pharmacists who have previously facilitated APPEL placements have found the experience enjoyable and rewarding. In surveys, 90% of pharmacists said they would recommend facilitating a placement to other pharmacists. The advantages of facilitating an APPEL placement include:
- Continuing Professional Development - APPEL Trainer Training can contribute to pharmacists CPD, as can the experience of facilitating a placement.
- Development of your talent pipeline – many students will look to start their career in the organisations or practice settings where they undertook their placements
- Engagement – participating in the APPEL programme provides you with the opportunity to increase awareness of your pharmacy/organisation. APPEL training and events provide fantastic networking opportunities.
The next 4th-year placements will run from the 27th of August to the 17th of December 2021. The deadline to confirm your interest in offering placements is the 1st of November 2020. You can do this by clicking on the link below: https://forms.gle/yxLf3D16P9GHTuzN6
If you have any questions or want further information, please call APPEL on 01-4025129 or email ops@appel.ie.
This webinar summarizes the most relevant comments to the V12 draft document of Annex 1 (appendix of Eudralex Vol. 4 EU GMP) as developed by the EIPG national working groups and delivered to EC for consideration for the preparation of the final Annex to be published. Comments are mainly focused on the key issues about the aseptic process, such as premises, personnel, production technologies and process monitoring.
For further details including registration information, see event flyer EIPG position on Annex 1-Focus on Main Issues.
PIER is delighted to collaborate with EIPG for a webinar 'How a pandemic has affected the pharma industry' on Wednesday 7th October 2020 @ 4.30pm. The speaker will be Dr Sheuli Porkess, Executive Director Research, Medical and Innovation at the Association of the British Pharmaceutical Industry (ABPI).
See event flyer for registration details EIPG PIER webinar 'How a pandemic has affected the pharma industry'.
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)
Find out more about the PBF and the work they do 