News
- 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.
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.
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.
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.
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:
- Understand the difference between the set of documents applicable under the EU Directive 2001/20 and those applicable under Regulation 536/14.
- Comprehend how to update the quality system to be in compliance with the new scenario.
- Allow the Sponsor to be aware of the new scenario in order to speed up the approval of the clinical trial.
- 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.
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.
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
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)
- BioPharmaChem 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 