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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
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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
A joint webinar with the European Pharmaceutical Students’ Association and EIPG is being held this Thursday 20th May 2021 at 17.00 GMT on “Understanding Advanced Therapies”.
SCOPE: The background to advanced therapies will be discussed including gene therapy, cell therapy, and tissue engineering. Examples will be shown of how advanced therapies are dramatically changing the way patients are treated for a wide variety of diseases. A discussion will be held on the role of pharmacists and their ability to advise patients about these products which have such huge potential for the future of medicine.
SPEAKER: Sunayana Shah is an expert in regulatory, medical, and pharmacovigilance policy development as well as technical, scientific, and regulatory intelligence at global level including working with WHO, European and UK organisations. Sunayana worked at the Association of the British Pharmaceutical Industry (ABPI), London, where, as Head of Regulatory and Safety Policy she advised the pharmaceutical industry and worked with senior UK and EU government officials on international regulatory policy issues, including the impact of Brexit. Previously, she led the scientific and medical affairs function at the Proprietary Association of Great Britain (PAGB) where she developed and implemented national and pan European and global OTC reclassification policy, regulatory expertise, and led the Professional Learning training programmes. Sunayana is a registered pharmacist and EIPG’s delegate for Great Britain. She is a consultant and recently co-authored a toolkit on cell and gene therapy for the International Alliance of Patient Organisations and IFPMA.
REGISTRATION: There is no registration for this webinar.
Free access is via the link: Zoom Meeting https://zoom.us/j/93920028291?pwd=WEI1NGlhZktrV3JaeEF3Q1U0eGx0dz09
Meeting ID: 939 2002 8291 Passcode: 576982
A PIER Career Focus webinar is being organised on Thurs 20th May 2021 at 1.00pm on the topic of 'Opportunities for Pharmacists in Manufacturing Operations' with Colm Murphy (UCB). Register via https://rb.gy/qtohny
See event flyer Career Opportunities in Manufacturing Operations webinar_20 May 2021.
The PIER Committee is delighted to host a virtual CPD meeting on the topic of 'What is New in Health Innovation and Entrepreneurship' on Thursday 10th June 2021.
https://zoom.us/j/92203441896?
Meeting ID: 922 0344 1896
Passcode: 279597
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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