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.
Join us for this webinar on the topic of ‘Work/Life Effectiveness in Crisis Times’ with Margaret Dorgan (The Catalyst Coach) on Tuesday 9th June 2020 @ 8.00pm.
About the Webinar:
This webinar is designed to help you identify opportunities for managing your time effectively, especially during our current global crisis. A key focus will be on how better management of time can help improve our performance and deliver a range of positive personal & professional benefits.
Participants will examine strategies for evaluating priorities, remaining focused and managing both their own and others expectations through engaging and thought-provoking exercises such as:
- Time Management Style Identify your Time Management Style
- Dialogue Identify and remedy time barriers
- 3P’s Managing conflicting priorities
- Buddy Contract Commitment to positive Change.
For dial in details, see Margaret Dorgan webinar login details_9th June 2020.
A PIER Career Focus webinar is being organised on Thurs 2nd April 2020 at 1.00pm on the topic of 'Overview of Medical Information Services provided by Pharma Companies' with David Coleman (Novartis HQ). For further information see event flyer PIER career webinar on Med Info Services_2nd April 2020.
Email education@pier.ie to register.
A PIER Career Focus webinar is being organised on Wednesday 11th March 2020 at 1.00pm on the topic of 'Overview of Market Access Opportunities in Pharma' with Shellie Jones (AbbVie). For further information see event flyer PIER Webinar Market Access Opportunities in Pharma_11th March 2020.
Email education@pier.ie to register.
The first of the EIPG/PIER webinars in 2020 will be held on Thursday 27th February 2020 in conjunction with School of Pharmacy, UCC.
Our speaker is Dr Annie Curtis, Lecturer and Principal Investigator of the Curtis Clock Laboratory, Royal College of Surgeons in Ireland. Dr Curtis believes that WHEN you take a medicine may be just as important as WHAT you take because up to half of the 100 top selling medicines are against a target that is controlled by our molecular clock, leading to daily changes in the expression of this target. Each of our cells has the capacity to tell the time of day. Dr Curtis will discuss the future of bringing chronobiology and chronotherapy into modern medicine.
For further information about this webinar and registration details, see event flyer EIPG PIER 'The Role of the Body Clock in Drug Development, Efficacy & Toxicity'.
The first PIER Career Focus webinar of 2020 is being organised on Thurs 16th January 2020 at 12.30pm on the topic of 'An Insight into Global Regulatory Affairs - CMC' with Michael Lennon (Alexion). For further information see event flyer PIER Regs CMC career webinar_16th Jan 2020.
Email education@pier.ie to register.
EIPG is organising a webinar on the European Directorate for the Quality of Medicines & HealthCare (EDQM) inspection programme to be held on Tuesday 10th December 2019 at 4pm.
Dr. Sotirios Paraschos, one of the EDQM Inspectors, will present on the EDQM role within the European regulatory framework, including its function within EU legislation of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs). The webinar will introduce the EDQM inspection programme and its relevance to CEPs, preparation, performance and follow-up of the inspections. In addition, there will be a review of the frequent types of issues observed during EDQM inspections.
Please register via the following link: http://newbusinessmedia.mn-ssl.com/nl/link?d=2nov&h=2rvs5585bsp71dvji0sjb65v6c&i=3og&iw=5&n=1aac&p=H301800627&s=wv&sl=ita&sn=1aac.
Attendance is free of charge for PIER members.
For further information on EDQM, see https://www.edqm.eu/.
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)
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