News
The PIER Committee is organising a virtual career information event 'Strategies for Successful Career Change' on Thursday 30th September 2021 (7.00pm-9.00pm). This event are a great opportunity for students, interns or patient facing pharmacists to get advice about job hunting and to hear from a panel of pharmacists who have made a career change in recent years (representing AstraZeneca, HPRA, Medisource, Novartis, Pfizer and Servier).
PIER members & non-members welcome to attend this particular event.
See event flyer for further information PIER 'Strategies for Successful Career Change' virtual event flyer_30th Sept 2021.
Register via https://docs.google.com/forms/d/1Tod1O341yAxGBxZU06lhRfKctA_YZJyJ0Lz9UmizfO4/edit
Overview of Webinar:
Over the last 20 years Physiologically - Based Pharmacokinetic (PBPK) Modelling and Simulation has developed and is now used extensively within Discovery and Development in the Pharmaceutical Industry. Its adoption has been driven by the availability of commercial software platforms and a realisation of the benefits to be gained including the potential to reduce the number of in vivo studies performed.This webinar will cover an introduction to PBPK modelling, what it is and how it can be applied to support Chemistry, Manufacturing and Controls (CMC) development.It will provide an overview of usage in oral, small molecule development, supported by examples from the areas of biopharmaceutics and formulation development. Current and potential future applications of PBPK modelling in Quality and Regulatory fields will also be discussed.
Learning Outcomes:
By the end of this webinar, you will be able to:
1. Understand the definition of a Physiologically - Based Pharmacokinetic (PBPK) model.
2. Demonstrate an awareness of how PBPK models can be used.
3. Appreciate the benefits and challenges in applying PBPK models in CMC areas.
About the Speaker:
Dr Jonathan Brown graduated in Pharmacy from University of Nottingham and is a registered UK pharmacist. He gained a PhD in Drug Delivery from the University of Manchester and subsequently joined Bristol-Myers Squibb. He has worked on the development of solid oral dosage forms and also in CMC project team leadership for over 20 years. He has worked extensively in the design of extended release systems and has strong understanding and experience of PBPK modelling of oral formulations. He is a co-founder of the Gastroplus User Group and has contributed to several academic-industrial consortia in the area of paediatric formulation and biopharmaceutics.
To Join the Webinar
Please register for the event by filling out the Webinar Registration Form in the event flyer EIPG PIER 'Physiologically-based PK modelling and simulation webinar'. The access instructions will be shown on the screen when you submit the form, for you to keep a record of them.
Continuing Education:
A certificate of attendance will be issued after the webinar. The session will be an hour of Continuing Education.
Please join us for lunchtime speednetworking on Friday 30th July 2021 from 1.00pm.
https://us06web.zoom.us/j/96609087487?pwd=a1YzcnBIYmRDZHNvYkdRdVZ4M3RRQT09
Meeting ID: 966 0908 7487
Passcode: 031907
European Medicines Registration Consultancy (EMRC) is an established pharmaceutical consultancy company based in Ashbourne offering an extensive range of regulatory affairs and compliance services to both Irish and international pharmaceutical companies, wholesalers and manufacturers.
A vacancy currently exists for an experienced Regulatory Affairs professional to undertake standard tasks including the following:
- Provide consultancy and practical assistance to pharmaceutical, medical device, food supplement and cosmetic companies as well as pharmaceutical wholesalers and manufacturers.
- Compile and submit MA variations to the HPRA, follow through SPC/PIL/artwork changes
- Local PV activities including ADR/PQC logs and reconciliations, literature searches
- Educational and Marketing material regulatory review and approval
- GDP QMS review, SOP and GDP training.
This role is flexible and can be tailored to suit the candidate’s circumstances i.e. full-time or part-time, short or long term, office based or work from home. The successful candidate would have a minimum of 3 years experience in regulatory, quality or compliance with a pharmaceutical company and would be familiar with HPRA and Irish regulatory requirements.
Please forward enquiries or declaration of interest to: Eimear O'Reilly at eoreilly@emrc.ie.
Posted: 10th July 2021
- Digital Therapeutics
- Remote Patient Monitoring
- Clinical Decision Support Solutions
- Telemedicine
- Connected Drug Delivery
- Use cases in CTs &R&D
- Data Analytics
- Opportunities for pharma
- Predictions
The PIER Committee is delighted to organise its first virtual site vist to the Pfizer Newbridge manufacturing site. It is one of Europe’s largest manufacturers of solid-dose pharmaceuticals. The facility currently supplies a largre range of products across a number of therapeutic areas: including cardiovascular, central nervous system and women's health to more than 100 markets across the world.
The virtual visit will take the following format:
- Introduction to the site by Kieran Coffey (Technical Services Lead)
- Panel disscusion with some of the pharmacists working on-site in areas including Quality and Tech Ops.
Register via: https://docs.google.com/forms/d/1Qcn2PFP3VQl-ACEyy75XteQ0tdI9b9Cb_1xVxHiAfEk/prefill.
Webex details will be provided closer to the date.
EIPG are organising a mini-Symposium 'The Post-COVID Era and Pharmacy' on Friday 18th June 2021 at 1.30pm BST (2.30pm CEST).
The event will allow EIPG members to consider the lessons learned from the Covid-19 pandemic: the repurposing of medicines for treatment, vaccines development, clinical trials design update, agility in drug development and regulatory flexibility.
It will be a great opportunity to hear and put your questions to the following speakers:
- Dr Fergus Sweeney, Head of the Clinical Studies and Manufacturing Task Force at the EMA covering the Clinical Trial Information System, Biological Health Threats and Vaccine Strategy
- Dr Derek O’Hagan, Global Head of Vaccine Chemistry and Formulation, GSK Vaccine Research, Cambridge, MA.
- Professor Mahendra G. Patel, Pharmacy and Ethnic Minority Communities Research Lead and Co-Investigator, PRINCIPLE Trial, University of Oxford
- Dr Oksana Pyzik, Lead of UCL Global Citizenship Programme, Global Health Adviser, UCL School of Pharmacy
The discussion about how pharmacists can shape the future in a post-COVID era will be chaired by Professor Gino Martino, Chief Scientist (Royal Pharmaceutical Society).
The Symposium is free for all members of EIPG Associations and will last for just over 2 hours. Please register via link in this event flyer EIPG 'Post-Covid Era Symposium_18th June 2021',
GSK currently have an exciting opportunity for a Quality Assistant (based at Citywest, Dublin) on a full-time basis for an 18-month fixed term contract. This position is to help support the Trading Partner Quality Team in the worldwide virtual wholesale distribution operations of GSK’s Pharma Trading Partner companies. It is a great opportunity to obtain a strong grounding experience of Good Distribution Practice (GDP) and the QMS (Quality Management Systems) in a virtual wholesale distributor.
See role profile: https://gsk.wd5.myworkdayjobs.com/GSKCareers/job/Ireland---Dublin/Quality-Assistant_290106-1.
Posted 24th May 2021
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 