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.

Continuing on with the PIER Career Focus webinars highlighting some of the careers that pharmacists hold in industry, Maria Cawley (Sanofi Genzyme) will present on 'Medical Affairs-A Rewarding Career for Pharmacists' on Thursday 19th September 2019 at 7.30pm. 

For further information see the event flyer PIER Career Webinar on Medical Affairs_19th Sept 2019

Email education@pier.ie to register. 

PIER in collaboration with EIPG & UCC School of Pharmacy is delighted to organise the following webinar 'The Development & Regulatory Approval of Orphan Medicines' on Tues 15th Oct 2019 at 4pm. 
 
Overview of Webinar
40 years ago, rare diseases and the development of medicines to treat them were not being addressed. Investment, research and development focussed on diseases where populations were large and the likely return on investment was favourable. Today, orphan medicines are rising stars. Some of the world’s best-selling medicines are for the treatment of orphan diseases. The potential return on investment is favourable and large pharma companies have grown their own and acquired rare disease companies. There are also hundreds of start-ups, blooming across the USA and Europe attracting funding and investment. This webinar will describe how legislative changes incentivised research and development in rare diseases, the pathways and procedures to develop and approve new orphan medicines and where to find trusted information. The webinar will cover the development and regulatory approval of orphan medicines in the European Union.
 
Learning Outcomes
By the end of this presentation, you will be able to:
  1. Define what is meant by an orphan disease
  2. Define what is meant by an orphan medicine
  3. Understand the incentives available to develop new orphan medicines
  4. Appreciate the special needs for the development of orphan medicines for children
  5. Consider the importance of re-purposing older medicines for the treatment of orphan diseases
  6. Consider formulation and supply problems specific to some orphan medicines
  7. Understand the lifecycle of an orphan medicine, including applying for orphan designation, applying for a Marketing Authorisation application for an orphan medicine, and postauthorisation activities
  8. Find trusted information on orphan diseases and medicines
About the Speaker
John Watson BSc MBA MTOPRA has worked for four SME biotechnology companies and several large pharma companies. He currently works for Zogenix International Ltd as Head of Regulatory Affairs Europe. John has vast experience in the strategy, preparation, submission, negotiation of approval and maintenance of medicines regulated using the EU centralised procedure including twenty Marketing Authorisations. He has planned and managed the development and submission of eight orphan medicine applications, and many CHMP and national scientific advice procedures.
 
 
To Join the Webinar
Please register for the event by filling out the form in the attached flyer EIPG PIER Orphan Medicines Webinar_15th Oct 2019
Further instructions will then be sent by e-mail.
 

PIER members are invited to a site visit at Alexion’s biologics manufacturing site in College Park, Blanchardstown (Eircode D15 R925) on Friday 13th September 2019 from 1.00-4.00pm.

Visitors will have the opportunity to visit different areas of the site including:

  • Quality Control Centre of Excellence
  • Global Packaging and Labelling facility
  • Window tour of the newly constructed Bulk Drug Substance facility.

For further information, see Alexion site visit flyer_13th Sept 2019

Numbers are limited so places will be allocated on a first come, first served basis. Email education@pier.ie to register before Monday 9th September 2019.

 

HiTech Health focuses on enabling healthcare companies to launch and support products. The company was established in 2013 in Dublin, Ireland, bringing together an experienced and multi-disciplinary team from across the pharmaceutical, biotechnology and medical device industries. Operating internationally, HiTech Health supports healthcare companies from the development to the launch and supply of products.

HiTech Health are now recruiting for the position of Qualified Person. This is an exciting role for a dynamic individual to join a growing organisation, to work with a number of clients and contribute to a variety of projects.

The role involves supporting Quality Assurance activities for HiTech Health as a service provider to clients. The candidate will play a key role in the development of the company. The ideal candidate will be responsible for ensuring quality compliance with U.S. and E.U. requirements from early development right through to commercial manufacturing and supply to patients.

Please see the following link for more information;     http://hitech-health.com/qualified-person/

 

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