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/.

PIER is happy to announce that we are now on Instagram ! Follow us on Instagram using the handle @pierpharmacists or using the link below to keep up-to-date with all of PIER’s news and events !

https://instagram.com/pierpharmacists?igshid=14m4e4wtjxl4p

The PIER 2019 Autumn CPD meeting & AGM will take place on Sat 23rd November 2019 in Clayton Liffey Valley, Dublin (9.30pm-1pm). The theme of the CPD meeting is 'Medicines Shortages'. Confirmed speakers include Dr Caitriona Fisher (Director Quality, Scientific Affairs and Communications, HPRA) and Edel Sweeney (Quality Director, Uniphar Group). 

The PIER AGM will take place after the CPD meeting. 

To register, email education@pier.ie before Thursday 21st November 2019. 

Veeva Systems, a global cloud based service provider to the life sciences industry are hiring for graduate positions based in Barcelona or Budapest. This would be an ideal opportunity for a young mobile pharmacist interested in IT. 

Pharmacist Donal MacConaill who previously presented on a PIER career webinar (https://vimeo.com/322455286) is happy to advise on the positions. Contact on donal.mcconnell@veeva.com. Password for webinar is posted in members' area of the PIER website.

For further information, see https://www.veeva.com/generationveeva/

Due to growth, Cook Medical in Limerick have opportunities in their Regulatory Affairs department at all levels from Associate to Manager level. From Limerick, the regulatory team are responsible for global regulation in over 60 countries for product classifications ranging from Class I to III. Involved throughout the device lifecycle from the design process through to post market, leading global projects and setting up a new EU Authorised Rep office, this is an exciting time to be part of regulatory in Cook! Your next career move awaits!

https://emea-cookmedical.icims.com/jobs/search?ss=1&searchRelation=keyword_all&searchCategory=23738&searchLocation=13267--Limerick

For further information about the company and these opportunities, see Cook Medical Overview

Overview of Webinar
The presentation will cover the GMP requirements and the practical implementation of a management system for quality related documentation. After an introduction referencing the relevant GMP norms and guidances, the different types of documents will be described with their function in the Quality System and their requirements. Paper and electronic based systems will be described with their peculiarities. The presentation will continue with a description of the most frequent deficiencies in documentation management, including some examples of Authorities’ observations during inspections (observations from FDA, EMA and MHRA inspections will be presented). Finally, some best practices will be presented, combining GMP compliance and efficiency in documentation management and recommended by the speaker based on his experience.
 
 
About the Speaker
Alessandro Regola is currently a free-lance consultant in Pharmaceutical Sciences with main activities in the areas of cGMP and Pharmaceutical Quality System, and in optimisation or problem solving/trouble shooting. He graduated from the University of Milan in Medicinal Chemistry and Pharmaceutical Technology and has extensive experience in the pharmaceutical industry. He spent ten years working for several different companies in R&D, first in organic synthesis of small molecules and then in pharmaceutical technology. He switched to drug product manufacturing, obtaining significant experience in GMP and Quality Systems applied to dosage forms ranging from sterile products to oral solids and semisolids. His last job in the pharma industry was as head of Quality Unit of the Garbagnate and Segrate sites of Bayer Health Care Manufacturing in Milano which included responsibility for Quality Assurance and Quality Control. He regularly collaborates with Academic and Professional Societies and holds lectures and presentations at University and Industry / Regulatory Meetings.
 
 
Learning Outcomes
By the end of this presentation, you will:
1. Understand norms and guidelines requirements for documentation management
2. Understand documentation types used in the pharma industry and their characteristics
3. Be familiar with the Authorities’ interpretation of requirements and most frequent observations during inspections
4. Be informed about best practices combining GMP compliance and efficiency in documentation management
 
 
To Join the Webinar
Please register for the event via link in event flyer EIPG PIER GMP Documentation Management webinar_18th Nov 2019
 
Further instructions will then be sent by e-mail.
 
 

PIER is collaborating with UCC School of Pharmacy & UCC Pharmacy Society to organise an industry career information event in the Brookfield Health Science Complex on Thursday evening 14th November 2019 (7.00pm-9.00pm). Hear from a panel of experienced pharmacists working in different industry roles including Commerical, Market Access, Medical Affairs, Regulatory Affair and Quality. For further details, see the event flyer PIER UCC Career Information Evening_14th Nov 2019

To register email piercareerevents@gmail.com before Tues 12th November 2019. 

Continuing on with the PIER Career Focus webinars highlighting some of the careers that pharmacists hold in industry, Dr Donal Og O'Donovan (Regeneron Ireland) will present on 'Introduction to Pharmacovigilance, Risk Management and Medicine Safety' on Wednesday 23rd Oct 2019 @ 1.00pm. See event flyer for further information PV, Risk Management & Drug Safety Career Webinar

Email education@pier.ie to register. 

PIER: Communications & Confidence Building Workshop (Pre-2020 Mentorship Programme)

Date:    Wednesday 13th November 2019

Time: 9.30am – 4pm

Location: Red Cow Moran Hotel, Dublin

 

Overview: 

The PIER committee is organising a one-day customised workshop for experienced patient-facing pharmacists who wish to transition into an industry role. It will also act as a forum to galvanise participation in the PIER 2020 mentorship programme due to commence in January 2020. The workshop will focus on building core competency in communications & individual confidence – leveraging participant’s transferrable skills into industry opportunities.

This will be an interactive workshop facilitated by external career consultant Margaret Dorgan to include role-play and positioning techniques.

Workshop Outputs:

● Communicate Effectively – Fundamental skills of listening, questioning & feedback.

● Identify individual skill set - Bridging a synergy within industry.

● Build Resilience, Optimism & Self Motivation.

● Highlight alignment across sectors with recruitment industry.

● Networking Skills – Rapport and Emotional Intelligence.

● SWOT analysis.

● Craft a Position Statement.

Attendance at this workshop is free for PIER members. Spaces are limited so early registration is recommended. To register, please email piermentorship@gmail.com with a brief summary of your background and professional experience.

See event flyer PIER Communications & Confidence Building Workshop_13th Nov 2019

Takeda are currently recruiting for the role of External Supply Quality Manager (Oncology) for the European region.

For further details, see the role profile on https://takeda.wd3.myworkdayjobs.com/External/job/Bray-Ireland/External-Supply-Quality-Manager--Oncology-Products--European-Region_R0011686-1.

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