The PIER 2018 Autumn CPD meeting & AGM will take place on Sat 1st Dec 2018 in Clayton Liffey Valley, Dublin (9.30pm-1pm). The theme of the CPD meeting is 'Insights into Rare Diseases'. The agenda is as follows: 

  • Aoife Coughlan (Genomics Medicine Ireland) 'Solving the diagnostic odyssey of rare diseases in Ireland'
  • Geraldine O'Dea (HPRA) 'An overview of the work of the Committee for Orphan Medicinal Products'
  • Linda Vittone (Vertex) ’From bench to bedside, the development of orphan medicines’.

The PIER AGM will take place after the CPD meeting. 

To register, email education@pier.ie before Thursday 29th November 2018. 

On Thursday November 29th 2018, the IIOP will host a pharmacy practice research event aimed at pharmacists currently involved in the area, and at those who would like to become involved. It is hoped that that this can help pharmacists who have identified research as an area for development through their CCSAT.

Registration is via the IIOP website.

For further information see, IIOP Pharmacy Practice Research Event Agenda and IIOP Pharmacy Practice Research Event Flyer

PIER in collaboration with EIPG are organising a webinar on the topic of 'Data Integrity' on Tues 11th December 2018 at 4pm GMT. The speaker is Dr Alessandro Regola who has extensive experience in GMP and quality systems. The session will be chaired by Dr Piero Iamartino, EIPG Vice-President, Technical and Professional Development.

Overview of Webinar: The presentation will cover the issue related to the integrity of GMP relevant data that the pharmaceutical industry has been struggling with for the past 5-7 years mainly due to violations recorded during Authority inspections to pharmaceutical (both API and drug product) manufacturing facilities. Most common and frequent compliance issues related to paper, IT or hybrid (paper+ IT) systems will be discussed. A recommended risk assessment and remediation approach will be presented, including the classification of affected system based on risk for the quality of the product and the patient health, the evaluation of the gaps and the prioritisation of corrective actions.

For further details on the webinar and how to register, see EIPG PIER webinar on Data Integrity_11th Dec 2018

 

 

PIER is delighted to announce that its 2018 Autumn CPD meeting & AGM will take place on Sat 1st Dec 2018 in Clayton Liffey Valley, Dublin (9.30pm-1pm). The theme of the CPD meeting is 'Insights into Rare Diseases'. Great speakers from Genomics Medicines Ireland (GMI), HPRA and Vertex will be presenting. 

To register, email education@pier.ie

Paraxel are currently recruiting for Consultants in their Kilmainham Dublin office. The website link is https://jobs.parexel.com/job/dublin/regulatory-affairs-consultant/877/9246740.

 

CMC Consultant Overview:

A Consultant must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services PC provides.

A consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market.

A consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Technical Lead, a Consultant assures the work of the entire team is delivered on time and that it meets client’s and PC’s quality expectations.

 

Qualifications:

-Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred

-Several years of experience in an industry-related environment

 

Skills required:

-Variation/Lifecycle Maintenance experience EU/RoW: Simple (Type I), complex variations (Type II) to EU markets in the CP and NP procedures, Renewals etc.

-Change Control assessment experience

-Capable of participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) with support of an SME

-Proactive’ and ‘efficient working method

-Strict adherence to timelines (both internal and HA deadlines)

-Excellent interpersonal and intercultural communication skills, both written and verbal

-Client-focused approach to work (Quality)

-Results orientation

-Teamwork and collaboration skills

-Critical thinking and problem-solving skills

-Proficiency in local language and extensive working knowledge of the English language

 

Posted 25th Oct 2018

EirGen Pharma in Waterford (part of OPKO, Miami, US) are recruiting a number of Science graduates to join their Regulatory/Clinical Affairs team with immediate start. The Regulatory department has a structured training program for graduates delivered by both internal and external trainers with extensive experience of Global Regulatory Affairs. This is an exciting opportunity to join an expanding Regulatory Affairs department supporting EirGen's newly built R&D facility in the space of New Drug Development and niche Generic drug development in a variety of dosage forms, including Oral Solid Dose – immediate and modified release, soft capsules and liquid fill hard capsules and Fill/Finish for both small molecules and biologics. See job description for further information EirGen Reg Affairs Office positions_Aug 2018

For anyone who wishes to apply they can send a copy of their CV to HR@Eirgen.com

Posted 19th Oct 2018 

 

PIER is organising a careers evening in RCSI College Hall for undergrads, interns and pharmacists interested in careers in the pharmaceutical industry. 

The event will take place on Wednesday evening 7th November 2018. The formal part of the evening will run from 6.30pm-9.00pm with refreshments available from 6.00pm.

Attendees will be invited to rotate around nine focus areas (Commercial, Consulting, Manufacturing/Tech Services, Market Access, Medical, Drug Safety/Pharmacovigilance, Quality & Compliance, HPRA, Regulatory Affairs) where they can learn about some of the interesting careers in industry by chatting to pharmacists working in the particular area. 

Email careerhub2@rcsi.ie to register.

For further information see, RCSI Careers Evening 7th Nov 2018

PIER in collaboration with EIPG are organising a webinar on the topic of 'Integrated Quality Management Systems'. The presenter is John Jolley (PharmaConsult Global) and will be held on Monday 15th October at 4pm (GMT). 

In his talk on the requirements of an Integrated Quality Management system, John will include the principles of applying quality risk management, the management of product and process deviations, CAPA and change control, audit management of inspections and the management of enterprise resource planning and supplier quality management.

Numbers are limited and are on a first come, first serve basis. Anyone applying to participate and then finding they are unable to do so must cancel their participation before the event.

For further information, see Integrated QMS webinar_15th Oct 2018

PIER in collaboration with EIPG are organising a webinar on the topic of 'FMD Implementation- Insights from a National Medicines Verification Organisation'.

The deadline for the implementation of the Delegated Regulation on Safety Features is fast approaching and industrial pharmacists throughout the entire pharmaceutical regulatory and supply chain will be interacting closely with their NMVO in the coming months. This webinar will provide insights into how an NMVO operates and an understanding of the importance of collaboration between all players and their national MVO, as part of the European network, in order to ensure the success of this project. The presenter is PIER member Leonie Clarke, Project Manager IMVO. It will be held on Tuesday 25th September at 4pm GMT.

Numbers are limited and are on a first come, first serve basis. Anyone registering to attend and then finding they are unable to do so must cancel their participation before the event.

For further information, see FMD webinar_25th Sept 2018

A recording of the recent EIPG/PIER webinar (FMD webinar_25th Sept 2018hosted by Leonie Clarke (IMVO) on 'FMD Implemenation-Insights from a National Medicines Verification Organisation' is now available in the members area of the PIER website. A copy of the presentation slides is also posted. Access is via password which is posted in the members area of the PIER website.