The second EIPG/PIER Webinar of 2021 will be held in conjunction with UCC School of Pharmacy on Monday 10th May 2021. The topic is 'The importance of Knowledge Management in both the Development and Manufacture of Medicinal Products'.
See attached flyer for registration details EIPG PIER 'Knowledge Management' webinar_10th May 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.
PIER is delighted to be collaborating with The Irish Pharmaceutical Student Association (IPSA) to organise a virtual information event on opportunities for early career pharmacists through graduate programmes.
For further information, see event flyer PIER IPSA virtual graduate programme information event_25 Feb 2021.
The first EIPG/PIER Webinar of 2021 will be held in conjunction with UCC School of Pharmacy on Wednesday 3rd February 2021. 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.
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 email@example.com.
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.
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'.
The PIER Committee is organising two virtual industry career information events on Thursday 3rd September 2020 & Thursday 10th September 2020 from 7.00-9.00pm. These events are a great opportunity for students, interns or patient facing pharmacists to hear from a panel of pharmacists who have transitioned into different industry roles in recent years. There will be different presenters and panel participants each evening so attendance at both events is recommended. PIER members & non-members welcome to attend.
Register via this link: https://docs.google.com/forms/d/e/1FAIpQLSfjKMAZaO457jvmCDPnEeKRBMVavPuSpa0LtgHzerWbv2Kj-w/viewform. Further information will be provided closer to the events.
PIER in collaboration with EIPG will co-host a webinar 'Consultation on the draft Annex 21: Importation of medicinal products, of the EudraLex Volume 4' on Wed 5th August 2020 at 4pm.
Overview of Webinar
The European Commission has announced a targeted stakeholders’ consultation on the draft Annex 21: Importation of medicinal products, of the EudraLex Volume 4. This new Annex, in which the Qualified Person (QP) has a key role, and which has been under discussion for a long time, provides guidance for the interpretation of the principles and guidelines of GMP for both human and veterinary medicinal products. The document intends to bring clarity to areas which have been unclear for some time, and the speaker will discuss the background to the Annex, the challenges which have existed within the EU Regulatory Framework, and how the proposed Annex may or may not address these challenges. The speaker will suggest potential areas of concern, and how delegates may wish to communicate these to the European Commission both via the European Commission’s own communication process, and through the participation of their member organisations in the consultation process within the European Industrial Pharmacists Group.
By the end of this presentation, you will:
About the Speaker
Stan O’Neill, a pharmacist from Trinity College, Dublin, is the Managing Director of The Compliance Group, a specialist consultancy group consisting of ex-Regulators. After qualifying as a pharmacist, Stan spent over five years working in the pharmaceutical industry in Regulatory Affairs, Marketing and Quality Assurance (Qualified Person) and then joined the Irish Medicines Board (IMB), now the Health Products Regulatory Agency (HPRA), for a period of ten years. In his capacity as a Senior Inspector, he performed GMP inspections throughout the world, represented Ireland at European level for the negotiation of standards of inspection for medicinal products and trained Inspectors at Irish, European and International levels. He has been a consultant to the pharmaceutical industry, Regulatory Authorities, Government Bodies and NGOs since 2009. He is the former PIER Chair.
To Join the Webinar
Please register for the event by filling out the form at https://forms.office.com/Pages/ResponsePage.aspx?id=JyXrHv_AJUeBnS4kTn1CfOCIkfr1hJNCpQuKaBczc51UNklOMUdaNlpZVTI5NkVESU4xUVFZS1kzViQlQCN0PWcu. Further instructions will then be sent in the form of a Calendar Invitation.
See event flyer Annex 21 webinar_5 August 2020.