Events

Created: 03 June 2022

Overview of Webinar

The revision of ICHQ2(R1): Validation of Analytical Procedures and the development of ICHQ14: Analytical Procedure Development reached the key ICH milestone of Step 2 publication for public consultation in March 2022. The combined topic Q2(R2)/Q14 represents an opportunity to provide guidance on how to apply enhanced development approaches (‘Quality by Design’) to analytical procedures and how to use the knowledge obtained to support routine use of procedures. Q2(R2)/Q14 will also have the potential to facilitate the selection or identification of development approaches that will reduce the risk incurred by post-approval changes to analytical procedures discussed in ICHQ12: Pharmaceutical product Lifecycle Management. This webinar will explain why these guidelines are being developed as well as highlighting the implications and opportunities.

Learning Outcomes

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

• How Quality by Design can be applied to Analytical Procedures (“Analytical Quality by Design” or AQbD) and learn about key concepts such as the Analytical Target Profile (ATP)
• What has changed in the revision of ICHQ2(R1) and what opportunities this may provide
• The purpose of ICHQ14 and what this new guideline means for the pharmaceutical industry.

About the Speaker

Philip Borman, director and senior fellow at GSK. Over many years, Phil has pioneered the adaptation of Quality by Design principles to analytical procedures and currently co-leads the EFPIA ICH Q2(R2) and ICH Q14 guidance on Quality by Design.  

For further information including registration link, see event flyer EIPG webinar 'Analytical Procedures ICH Q2(R2) and Q14'_15 June 2022. 

Created: 24 April 2022

The PIER Committee is delighted to organise the 'Protecting your rationale self - how to apply intelligence for wise decisions' lunchtime webinar on Wed 27th April 2022 from 1.05pm-2.00pm.

The presenter is Fiona Fennell of Think4Purpose (https://www.think4purpose.com/), 

Outline agenda is as follows: 

 How ‘rational’ has evolution shaped us to be?
- Which definition of 'rationality' underscores Evidence-Based Medicine?
- Why is 'Self-Knowledge' important for well-informed Risk-Based Decision-Making? &
- Will thinking more philosophically in Work 4.0 offer benefits to Patients?

All PIER members and non-members welcome to attend. 

Join Zoom Meeting https://us06web.zoom.us/j/81473536005?pwd=QVJyQjNRUE5vMUNWcmVnd1ZEMklNdz09

Meeting ID: 814 7353 6005
Passcode: 624176

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.