News

Created: 31 March 2022

Pfizer CMC Regulatory Affairs (Vaccines) is recruiting for a Regulatory Stragegist role. This is a contract role and would suit a recently qualified pharmacist or experienced patient facing pharmacist looking to gain experience in CMC. 

See job description Pfizer CMC Regulatory Strategist role_March 2022. 

Posted 30th March 2022

Created: 21 March 2022

• Kevin Sweeney, 'Experiences & Reflections from Data Integrity Investigations in the Pharmaceutical Industry' on 6th April 2022. 
• Fiona Fennell, 'Protecting your rationale self - how to apply intelligence for wise decisions' on 27th April 2022. 

Register via PIER April CPD webinars registration link. 

Created: 21 March 2022

About the Speaker

Giustino Di Pretoro is a Scientific Director at Janssen Pharmaceutica, a Johnson & Johnson Company. He is a subject matter expert and drug product development lead for continuous manufacturing, and coordinator for a series of academic collaborations within the field. Before joining Johnson & Johnson, Giustino was Team Leader and Principal Scientist at Novo Nordisk AS in Denmark and was previously R&D and Business Development Manager for a Swiss contract manufacturing organisation, focussing on novel technologies. Giustino holds a Ph.D. in Pharmaceutical Technology and an MSc.in Industrial Pharmacy from the University of Milan. During his Ph.D. he worked as a Research Scientist in the Chemical Engineering and Biotechnology Department, Cambridge University, England and later as a visiting postdoc in Pharmaceutical Technology at the University of Düsseldorf, Germany.

About the Webinar

For more than 50 years, pharmaceuticals have been produced using a method known as “batch manufacturing,” a multi-step, lengthy process that usually involves the use of large-scale equipment. However, recent advances in manufacturing technology have prompted the pharmaceutical industry to consider moving away from batch manufacturing to a faster, more efficient process known as “continuous manufacturing”. The Regulatory Agencies are taking proactive steps to facilitate the pharma industry’s implementation of emerging technologies, including continuous manufacturing, to improve product quality and to address many of the underlying causes of drug shortages and recalls. Our speaker will provide his expert practical experience of continuous manufacturing.

Learning Outcomes

By the end of this webinar, you will be able to: −

• Define the differences between continuous and batch manufacture.
• Understand why the transition to continuous manufacture in many pharma companies is still in its early stages.
• Reflect on a leading industrial expert’s opinion on the advantages of continuous manufacture.
• Understand the official definitions of batch and control strategies in continuous manufacturing.
• Know where to find information and advice on the transition to continuous manufacture.

See event flyer for registration details EIPG Continuous Manufacturing of Pharmaceuticals: Higher Quality, Greater Flexibility_30 March 2022. 

Created: 01 December 2021

The PIER Committee in collaboration with TCD School of Pharmacy & Pharmaceutical Sciences are hosting the 'In Conversation with Emer Cooke' virtual event on Thursday evening 9th December 2021 (7.00pm GMT).

See event flyer for further information In Conversation with Emer Cooke virtual event_9th December 2021. 

Register via https://forms.office.com/r/RBXZAFSiQi.

Created: 24 November 2021

The PIER Committee Autumn CPD meeting 'COVID-19: The Journey so Far' has a great line up of speakers from HPRA and IQVIA. 

Email education@pier.ie to register. 

Created: 04 November 2021

About the Speaker:

Luciano Gambini began his career as an analyst in R&D. He moved into Validation and Quality Assurance for the Pharmaceutical Development Department of Farmitalia Carlo Erba. At Pharmacia, later Pharmacia and Upjohn, he spent his working life in global R&D Quality Assurance setting up the internal policies for the quality of Investigational Medicinal Products (IMPs). He is currently the coordinator of the AFI (Italian Association of Industrial Pharmacists) working group on manufacture of IMPs. The meeting will be chaired, and the subject introduced by Irene Gonzalez-Conde, Board Member of AEFI (Spanish Association of Industrial Pharmacists).

Overview of Webinar:

From the 31st January 2022 the “new” Clinical Trial Regulation 536/14 and its reference documents for IMP manufacture will enter into force. The following are some of the questions arising:

• Is this a big cultural change for people involved in IMP manufacture?
• How do the interactions between GMP and GCP evolve?
• How much should the Quality System for IMP manufacture be updated?
• What are the critical differences between GMPs for IMPs and those for the commercial pharmaceutical products and which are their interactions?
• Do the responsibilities for the Sponsor and the Qualified Person remain the same?
• Particularly important for IMPs, are the labelling requirements the same?

The aim of the webinar is to provide initial answers to these questions, highlighting the differences between the current and new regulations and to propose possible solutions to cover the gaps between the old and new scenario.

Learning Outcomes:

By the end of this webinar, you will be able to:

1. Understand the difference between the set of documents applicable under the EU Directive 2001/20 and those applicable under Regulation 536/14.
2. Comprehend how to update the quality system to be in compliance with the new scenario.
3. Allow the Sponsor to be aware of the new scenario in order to speed up the approval of the clinical trial.
4. Give the QPs the tools to certify the batch of IMP according to the new set of guidelines.

Registration:

Please register for the event by filling out the Webinar Registration Form in the event flyer EIPG PIER IMP Manufacturing in Era of Clinical Trial 536/14 webinar. The 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.

Created: 04 November 2021

The PIER Committee is organising a virtual career info 'Exploring Alternate Career Options' event on Thursday evening 11th November 2021 (7.30pm-8.30pm). This event will feature a mixed panel of pharmacists working in alternate careers related to healthcare or the life sciences. 

• Dr Evin Allen (MSD Brinny)
• Avril Byrne (Optum)
• Catherine Mulhall (Sanofi Consumer UK)
• Anita Nolan (Department of Health)
• Dr Kieran Walsh (HIQA)

The event will be chaired by Rosemarie Tully (Avadel & PIER)

Register for the event using the QR code in the event flyer PIER 'Exploring Alternate Career Options'_11th Nov 2021. 

Created: 14 September 2021

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