Events
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 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.
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.
Leaning Outcomes
By the end of this presentation, you will:
- Understand the potential implications of the proposed Annex 21
- Understand how delegates may communicate their concerns to the European Commission.
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.
The PIER Committee will host a virtual speed networking event on Thursday evening 9th July 2020 from 8.00pm. Great opportunity to meet new people. All welcome including non-PIER members.
To register email: pierevents20@gmail.com.
Join us for this webinar on the topic of ‘Take Action to Unlock Value-What tangible actions can you take to move your project forward' with pharmacist Tom O'Brien (www.sprintmodo.com) on Tuesday 23rd June 2020 @ 8.00pm.
About the Webinar:
Have you ever sat in a team meeting and listened to challenges being discussed that sound remarkably similar to the challenges raised in the same meeting 6 months ago? At these meetings everyone has great intentions to solve the challenges, but when back to the day job, nothing changes. Frustrating right?
You can be the one to help your team to move from ideas to action.
This webinar will explore the importance of having a value-based approach to identification of key actions to be taken. It will introduce some key principles of agile that can help non-software development teams to break a challenge into small pieces and build momentum towards addressing the challenge.
Participants will be exposed to the following:
- Tangible actions to unlock value
- Agile scrum application to non-software development teams
- Tools to help structure the ideation to action process
- Discussion on the application of the approach to the Pharma industry.
See Zoom login details Tom O'Brien webinar dial in details_23rd June 2020.
The PIER Committee invite you to a Virtual Quiz Night on Friday 19th June 2020 from 8pm. Individual and team (up to 4 per team) registration welcome. Individuals who register will be randomly assigned to a team on the night. Members and non-members welcome to attend.
Zoom Rooms and Google Forms will be technology used. There will be a number of rounds of questions including some pharmacy related ones.
To register, please email pierevents2020@gmail.com.
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 